[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sepsis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sepsis":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,280,0,25,[9,44,77,105,130,163,196,222,243,270,298,323,346,374,407,426,448,468,485,510,541,568,591,617,643],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053441","monitoring-of-septic-shock-induced-immunosuppression-100053441",false,"NCT07698093","Monitoring of Septic Shock-induced Immunosuppression","Immunological and Clinical Monitoring of Patients With Septic Shock in Intensive Care Unit : In-depth Immunophenotyping of Circulating Immunoregulatory Cells During Sepsis","IMMUNOSEPSIS 5","Inclusion Criteria:\n\n* Men or women aged 18 years or over\n* Hospitalised patients with septic shock that began less than 48 hours prior to screening, defined by:\n* the presence of a diagnosed or suspected site of infection requiring microbiological sampling\n* the need for vasopressor therapy to maintain a mean arterial pressure ≥ 65 mm Hg\n* hyperlactataemia \\> 2 mmol\u002FL (18 mg\u002FdL) within 24 hours of the start of vasopressor therapy despite adequate fluid resuscitation (30 ml\u002Fkg).\n* A patient or relative who has been informed of the study protocol and has not objected to participating in the study\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* People not covered by a social security scheme or similar scheme\n* Adults subject to legal guardianship (guardianship, curatorship)\n* Patients with a language barrier\n* Persons deprived of their liberty by a judicial or administrative decision\n* Subjects participating in another interventional research study involving an exclusion period that is still ongoing at the time of pre-inclusion and which, in the investigator's judgement, may interfere with this study","ALL","18 Years",{"count":21,"type":22},300,"ESTIMATED","OBSERVATIONAL","Septic syndromes are a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units (ICU). While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immune response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (cytomegalovirus (CMV) or Herpes Simplex Virus (HSV)) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. New promising therapeutic strategies are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients.\n\nRecent studies have described the induction of immunoregulatory cells (of myeloid and lymphoid origin) following septic shock and have revealed a similar induction kinetics across all subpopulations of regulatory cells. Nevertheless, these observations need to be confirmed and linked to the underlying mechanisms responsible for the induction of these cells (notably the activation of the inflammasome pathway), which remain largely unknown.\n\nIMMUNOSEPSIS 5 study will therefore, as part of a prospective observational study involving a large cohort of patients, demonstrate the concurrent induction of all regulatory cell subpopulations following sepsis and the activation of the hyper-inflammatory response, including the inflammasome pathway. The association between these parameters and patient outcomes will also be assessed (death and\u002For the occurrence of a secondary infection).",[26],"Sepsis",[28,29,30],"SEPSIS","Immune response","Circulating immunoregulatory cells","NOT_YET_RECRUITING","2026-07-09",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":22},"2026-09-01",{"date":39,"type":22},"2031-12-01",{"name":41,"class":42},"Hospices Civils de Lyon","OTHER",5,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":53,"targetDuration":55,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100053330","outer-membrane-vesicle-and-ferroptosis-related-signatures-in-sepsis-associated-acute-lung-injury-caused-by-extra-pulmonary-hypervirulent-klebsiella-pneumoniae-100053330","NCT07686887","Outer Membrane Vesicle and Ferroptosis-Related Signatures in Sepsis-Associated Acute Lung Injury Caused by Extra-Pulmonary Hypervirulent Klebsiella Pneumoniae","Circulating Bacterial Outer Membrane Vesicle Signatures and Ferroptosis-Related Biomarkers in Sepsis-Associated Acute Lung Injury Among Patients With Extra-Pulmonary Hypervirulent Klebsiella Pneumoniae Infection: A Prospective Observational Translational Cohort Study","OMV-FERRO-ALI","Inclusion Criteria:\n\n* Age 18-85 years .\n* Clinical suspicion of infection with acute organ dysfunction consistent with suspected sepsis at the time of enrollment, as determined by the treating clinical team.\n* Presumed extra-pulmonary source of infection at enrollment, including but not limited to hepatobiliary, urinary, intra-abdominal, skin and soft-tissue, vascular catheter-related, or primary bloodstream infection.\n* Blood cultures and\u002For clinically indicated source cultures obtained or ordered as part of routine clinical care.\n* Enrollment and first research blood collection completed within 6 hours after initiation of the clinical sepsis evaluation.\n* No evidence of acute lung injury at the index time point, according to the protocol-defined criteria.\n* Written informed consent obtained from the participant or legally authorized representative, unless an ethics-approved deferred-consent procedure is used.\n\nExclusion Criteria:\n\n* Suspected or confirmed primary pulmonary infection at enrollment, including community-acquired pneumonia, hospital-acquired pneumonia, ventilator-associated pneumonia, or aspiration pneumonia.\n\nAcute lung injury or acute respiratory distress syndrome present at the index time point.\n\n* Acute cardiogenic pulmonary edema, acute decompensated heart failure, or another condition that would preclude reliable adjudication of subsequent non-cardiogenic acute lung injury.\n* Recent inhalation injury, near-drowning, major thoracic trauma, or transfusion-related acute lung injury.\n* Previous enrollment in this study.\n* Inability to obtain informed consent from the participant or legally authorized representative when deferred-consent procedures are not permitted by the local ethics committee.","85 Years",{"count":54,"type":22},120,"28 Days","This prospective observational translational cohort study will investigate whether extra-pulmonary infection caused by hypervirulent Klebsiella pneumoniae (hvKP) is associated with an increased risk of sepsis-associated acute lung injury (SALI), compared with infection caused by classical Klebsiella pneumoniae (cKP). The study will further examine whether circulating bacterial outer membrane vesicle (OMV) signals and ferroptosis-related biomarker profiles are associated with subsequent SALI development.\n\nAdults with Sepsis-3 and microbiologically confirmed extra-pulmonary K. pneumoniae infection will be enrolled within 6 hours of sepsis recognition. Patients with acute lung injury at enrollment will be excluded from the primary cohort. Blood samples will be collected at enrollment, 24 hours, and 72 hours. Clinical isolates will undergo molecular characterization to classify infections as hvKP or cKP. The primary outcome will be new-onset SALI within 7 days after enrollment. A nested translational substudy will evaluate the effects of patient-isolate-derived OMVs on human pulmonary microvascular endothelial cells.\n\nThe study will not alter antimicrobial therapy, source control, respiratory support, fluid management, or any other aspect of routine clinical care.",[26,58,59,60],"Acute Lung Injury(ALI)","Klebsiella Pneumoniae Infection","Hypervirulent Klebsiella Pneumoniae Infection",[62,63,64,65,66,67,68,69],"Hypervirulent Klebsiella pneumoniae","Extra-pulmonary infection","Sepsis-associated acute lung injury","Bacterial outer membrane vesicles","Ferroptosis","Pulmonary microvascular endothelial cells","Lipid peroxidation","Endothelial barrier dysfunction",{"date":34,"type":35},{"date":72,"type":22},"2026-07-06",{"date":74,"type":22},"2030-07-30",{"name":76,"class":42},"Southeast University, China",{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100645274","metabolic-and-functional-study-of--t-cells-in-critically-ill-patients-100645274","NCT07680816","Metabolic and Functional Study of γδ T Cells in Critically Ill Patients","Subset-specific Metabolic Adaptation and Functional Remodeling of Gamma Delta T (γδ T) Cells in Critically Ill ICU Patients: A Single-center, Prospective, Observational Cohort Study.","Inclusion Criteria:\n\n1. Healthy Control Group (NHC):\n\n   * Age ≥ 18 years.\n   * No acute or chronic major diseases.\n   * Provide written informed consent.\n2. Non-septic Critical Illness Group (CI-NS):\n\n   * Age ≥ 18 years.\n   * Admitted to the ICU and meeting the definition of critical illness.\n   * Excluded from sepsis according to the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points).\n   * Written informed consent provided by the participant or legally authorized representative.\n3. Septic Critical Illness Group (CI-Sep):\n\n   * Age ≥ 18 years.\n   * Admitted to the ICU and meeting the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points).\n   * Written informed consent provided by the participant or legally authorized representative.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Known immunodeficiency, HIV infection, active hematologic malignancy, or history of hematopoietic stem cell or solid organ transplantation within the past 3 months.\n* Receipt of T-cell-targeted immunosuppressive therapy (e.g., antithymocyte globulin, calcineurin inhibitors, mycophenolate mofetil, methotrexate, or high-dose corticosteroids \\>1 mg\u002Fkg\u002Fday prednisone equivalent) before ICU admission or within 24 hours after ICU admission.\n* Use of immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1\u002FCTLA-4 antibodies) within the past 6 weeks.\n* Expected ICU stay \\\u003C 24 hours or imminent risk of death (moribund state).\n* Pregnancy or breastfeeding.\n* Active major bleeding.\n* Inability to obtain informed consent.",true,"80 Years",{"count":87,"type":22},105,"This prospective observational cohort study investigates the subset-specific metabolic adaptation and functional remodeling of cytotoxic γδT cells in critically ill patients with and without sepsis. Emerging evidence indicates that γδT cells, as a bridge between innate and adaptive immunity, play a critical role in early anti-infection defense during sepsis. However, the functional status and underlying regulatory mechanisms of cytotoxic γδT cells in septic patients remain incompletely understood. Our preliminary single-cell transcriptomic analysis revealed that cytotoxic γδT cells from septic patients exhibit significant alterations in cytotoxicity-associated molecules (GZMB, PRF1, GNLY) and mitochondrial oxidative phosphorylation (OXPHOS) pathway genes, particularly COX6C, which correlates with cytotoxic effector molecule expression. This study aims to systematically characterize the proportion, cytotoxicity, and mitochondrial metabolic function of circulating cytotoxic γδT cells across three cohorts: healthy controls, critically ill non-septic patients, and critically ill septic patients. By integrating flow cytometry, mitochondrial function assays, and functional validation experiments, we seek to elucidate the role of COX6C-mediated mitochondrial metabolic abnormalities in cytotoxic γδT cell dysfunction, providing theoretical basis for understanding immune dysregulation in sepsis and identifying novel therapeutic targets.",[26,90,91,92,93,94,95],"Critical Illness","Immunosuppression","MODS","Mitochondrial Diseases","Dysbiosis","γδ T Cells","2026-07-01",{"date":98,"type":35},"2026-07-02",{"date":100,"type":22},"2026-07-15",{"date":102,"type":22},"2027-07-15",{"name":104,"class":42},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100506542","correlation-of-memory-cd8-t-cells-with-sepsis-severity-and-mortality-a-single-center-unblinded-prospective-non-interventional-observational-study-100506542","NCT05875740","Correlation of Memory CD8+ T Cells With Sepsis Severity and Mortality: a Single-center, Unblinded, Prospective, Non-interventional, Observational Study","Inclusion Criteria:\n\nPatients aged 18-60 years old without restriction of gender, race, religion, creed or nationality; No sedative drugs with elimination half-life were used before inclusion in the study; Patients and\u002For their family members know and agree to participate in the trial.\n\nExclusion Criteria:\n\nHistory of solid organ or bone marrow transplantation; Diseases that may affect immune-related indicators, such as autoimmune diseases such as rheumatoid arthritis and SLE, or hematological malignancies such as leukemia and lymphoma; Have received radiotherapy or chemotherapy within the past 30 days, or have received immunosuppressive drugs (tripterygium, mycophenolate, cyclophosphamide, FK506, etc); Pregnancy or lactation; Chronic nephrosis; Severe chronic liver disease (child-Pugh: Grade C); alcohol or opioid dependence, mental illness, or severe cognitive impairment; Patients and\u002For their family members refuse to participate in the trial.","60 Years",{"count":113,"type":22},30,"Sepsis is defined as a life-threatening organ dysfunction that is caused by a dysregulated host response to infection. Severe sepsis is the most common cause of death among critically ill patients in non-coronary intensive care units (ICU). Sustained excessive inflammation and immune dysfunction have been confirmed to play a key role in organ damage and early death of sepsis patients. Therefore, it is important to reduce excessive inflammatory response mediated by immune cells and pro-inflammatory cytokines in the acute phase of sepsis.\n\nSingle-cell RNA sequencing performed on both septic patients and mice suggest that changes in Tcm (CD3+ CD8+ CD44+ CD127+ CD62L+) and Tem (CD3+ CD8+ CD44+ CD127+ CD62L -) in the acute phase of sepsis may play an important role in sepsis. In addition, animal researches showed that Tcm and Tem decreased decreased continuously at 24, 48 and 72h after cecal ligation and perforation (CLP) in mice, and the adoptive transfer of Tcm , sorting from spleen of mice 24h after CLP , but not Tem improved 7-day survival rate of sepsis mice.\n\nThis observational study is aimed to investigate the quantity and proliferation of Tcm and Tem in the acute phase of sepsis and their correlation with severity level and mortality of septic patients in ICU.",[26,116],"Inflammatory Response",[118,119,120,121],"sepsis","CD8+ T cell","central memory CD8+ T cell","inflammatory response","RECRUITING",{"date":98,"type":35},{"date":125,"type":35},"2023-09-06",{"date":127,"type":22},"2026-09-30",{"name":104,"class":42},1,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":129},"100644724","ulinastatin-on-systemic-immune-inflammation-in-patients-with-complicated-intra-abdominal-infection-100644724","NCT07672496","Ulinastatin on Systemic Immune-Inflammation in Patients With Complicated Intra-Abdominal Infection","A Single-Center Randomized Controlled Pilot Study on the Effect of Ulinastatin on Systemic Immune and Inflammatory Response in Patients With Complicated Intra-Abdominal Infection","UTI-cIAI","Inclusion Criteria:\n\n1. Able to provide written informed consent voluntarily.\n2. Age ≥ 18 years old, any gender.\n3. Diagnosed with severe complicated intra-abdominal infection (cIAI) within 48 hours, consistent with the 2025 expert consensus for cIAI diagnosis. Diagnosis is confirmed by clinical symptoms (fever, abdominal pain, distension, etc.), abdominal imaging (CT\u002Fultrasound\u002FMRI), intraoperative findings, or positive pathogen culture of abdominal drainage fluid.\n4. Baseline Sequential Organ Failure Assessment (SOFA) score ≥ 2 points.\n\nExclusion Criteria:\n\n1. Severe immune deficiency conditions, including AIDS, prior solid organ or bone marrow transplantation, HIV infection with CD4 count \\\u003C 200 cells\u002Fmm³, long-term high-dose glucocorticoid therapy (prednisone \\> 20 mg\u002Fday), ongoing chemotherapy for malignant tumors, or absolute neutrophil count \\\u003C 1000 cells\u002Fmm³.\n2. Severe irreversible underlying diseases, including chronic renal failure requiring dialysis, Child-Pugh grade C liver disease, liver disease with severe portal hypertension, or acute liver failure.\n3. Patients with active malignant tumors, pregnancy, or severe psychiatric disorders.\n4. American Society of Anesthesiologists (ASA) physical status grade IV or above.\n5. Severe coagulation disorder defined as ISTH-DIC score ≥ 5 points.\n6. Critically ill patients with expected death within 48 hours after admission.\n7. Known allergy to ulinastatin or any ingredients of the study preparation.\n8. Any condition that, in the judgment of the principal investigator, makes the patient inappropriate for trial participation.",{"count":139,"type":22},165,"INTERVENTIONAL",[142],"NA","Complicated intra-abdominal infection (cIAI) triggers dysregulated systemic inflammation and immune paralysis leading to high organ failure and death risk. Ulinastatin is a protease inhibitor with anti-inflammatory properties, but its dose-related effects on immune-inflammation of cIAI patients remain unclear. This single-center single-blinded three-arm randomized controlled pilot study enrolls adult cIAI patients (≥18 years, SOFA≥2) at Fujian Medical University Union Hospital. Eligible patients are randomized into low-dose ulinastatin, high-dose ulinastatin and normal saline placebo groups (1:1:1, 5 days intravenous treatment plus standard care), total planned enrollment 165 participants after 10% dropout adjustment. Primary endpoint is Day5 change of Systemic Immune-Inflammation Index (SII); secondary outcomes include serial inflammatory biomarkers, SOFA variation, organ dysfunction, hospitalization duration, 28-day mortality and safety profiles. This pilot aims to clarify ulinastatin's immune-modulating effect and inform future large RCT design.",[145,146,26,147],"Complicated Intra-abdominal Infection (cIAI)","Systemic Inflammatory Response","Immune Dysfunction",[149,150,151,152,153],"immune dysfunction","Complicated intra-abdominal infection","Ulinastatin","SII","inflammation","2026-06-26",{"date":156,"type":35},"2026-06-29",{"date":158,"type":22},"2026-10-30",{"date":160,"type":22},"2028-06-30",{"name":162,"class":42},"Fujian Medical University Union Hospital",{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":171,"targetDuration":4,"studyType":140,"phases":173,"briefSummary":174,"conditions":175,"keywords":180,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":195},"100620841","myokine100-system-closed-loop-electrical-muscle-stimulation-to-mitigate-icu-acquired-weakness-in-medical-icu-patients-100620841","NCT07362862","MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients","Safety and Feasibility of the MyokinE100 System in ICU Settings to Mitigate ICU Acquired Weakness","ICUAW","Inclusion Criteria:\n\n* Admitted to ER or ICU within the previous 48 hours\n* APACHE II score ≥ 13\n* Meets the criteria for sepsis or severe sepsis\n* Baseline Clinical Frailty Scale (CFS) ≤ 4\n\nExclusion Criteria:\n\n* Anticipated transfer to an ICU not participating in this study\n* Expected length of ICU stay \\\u003C 48 hours\n* Myopathies (e.g. congenital)\n* Acquired myopathies with CK levels 5-times above the upper limit of normal\n* Unable to transfer from bed to chair at baseline\n* Moribund\n* Comfort care\n* New onset deep vein thrombosis within the previous 6-months\n* Malignancy in lower limb\n* Technical obstacles - fracture, burns, amputation\n* Open wound or skin abrasion at the garment application site\n* Pregnancy\n* Pacemaker and implantable cardioverter-defibrillator",{"count":172,"type":22},50,[142],"The goal of this clinical trial is to learn if a new medical device that sends electrical signals to the thigh muscles is safe and easy to use for people in the ICU (Intensive Care Unit) who are at risk of losing muscle strength. It will also explore whether this treatment can help slow down muscle weakening.\n\nThe main questions this study aims to answer are:\n\n* Do participants develop medical problems when receiving electrical muscle stimulation in the ICU?\n* Is electrical muscle stimulation a practical way to help reduce muscle weakness in critically ill patients?\n\nResearchers will compare the control group (standard of care) to the intervention group (standard of care plus 60-minute sessions of electrical muscle stimulation daily during the ICU stay) to see if the device is safe and easy to use.\n\nParticipants will:\n\n* Receive either standard of care or standard of care plus electrical muscle stimulation of the thigh muscles\n* Have their muscle strength checked during the study\n* Complete a survey three months after ICU discharge to check on their recovery",[26,90,176,177,169,178,179],"ICU-acquired Muscle Weakness","ICU-acquired Weakness","Sarcopenia","Secondary Sarcopenia",[181,182,183,184,26,185,186],"Electrical muscle stimulation","Electrical Impedance Myography","Bioimpedance","Rehabilitation","Critical illness","ICU-acquired weakness",{"date":156,"type":35},{"date":189,"type":35},"2026-05-05",{"date":191,"type":22},"2027-08-31",{"name":193,"class":194},"Health Discovery Labs","INDUSTRY",3,{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":203,"targetDuration":205,"studyType":23,"phases":4,"briefSummary":206,"conditions":207,"keywords":210,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":218,"leadSponsor":220,"locationsCount":4},"100644641","t6a-biomarker-for-detection-of-bacterial-infection-in-newborn-infants-100644641","NCT07670624","T6A Biomarker for Detection of Bacterial Infection in Newborn Infants","T6ASepsis","Inclusion Criteria:\n\n* Newborn infants who require blood testing for screening for bacterial infection OR treating physician suspects bacterial infection in newborn infant\n* Signed informed consent form\n\nExclusion Criteria:\n\n1. Refusal to participate in study or not providing written informed consent by caregivers\u002Fparents\n2. Antibiotic treatment of any kind.",{"count":204,"type":22},210,"1 Week","This study aims to assess the efficacy of a new biomarker, N6-threonylcarbamoyladenosine (t6A), for the early diagnosis of Early-Onset Sepsis (EOS) in newborns.",[26,208,209],"Newborn Sepsis","Biomarker Discovery",[211,212,213,214],"t6a","newborn sepsis","infectious disease biomarker","biomarker","2026-06-25",{"date":154,"type":35},{"date":96,"type":22},{"date":219,"type":22},"2029-01-31",{"name":221,"class":42},"Salzburger Landeskliniken",{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":140,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":240,"leadSponsor":242,"locationsCount":4},"100644582","fmt-for-90-day-outcome-of-clinical-use-in-icu-sepsis-100644582","NCT07670299","FMT for 90-Day Outcome of Clinical Use in ICU Sepsis","Fecal Microbiota Transplantation for 90-Day Outcome of Clinical Use in ICU Sepsis: a Single-Center, Open-Label, Randomized Controlled Trial","FOCUS","Inclusion Criteria:\n\n* Age ≥ 18 years, any ethnicity, any gender.\n* Diagnosis of sepsis according to the Sepsis-3 criteria (infection with an acute change in SOFA score ≥ 2 points).\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Patients whom the attending clinician considers to have a high risk of death within 5 days, or patients with treatment limitations in place.\n* Active major gastrointestinal bleeding, perforation, or other severe impairment of the intestinal barrier.\n* Patients unable to tolerate enteral nutrition meeting ≥50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula.\n* Planned or recent abdominal surgery (within 14 days).\n* Current diagnosis of fulminant colitis or toxic megacolon.\n* Recent receipt of high-risk immunosuppressive or cytotoxic therapy, such as rituximab, doxorubicin, or moderate-to-high-dose corticosteroids (≥20 mg\u002Fday of prednisone or equivalent) for more than 4 consecutive weeks.\n* Pregnant or breastfeeding women.\n* Participation in another clinical trial as a subject at the time of enrollment or within 3 months prior to enrollment.\n* Subjects for whom the validity of informed consent is questionable, including those with psychiatric disorders, intellectual disability, poor motivation, or other conditions that may limit their ability to provide informed consent.","70 Years",{"count":232,"type":22},60,[142],"Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, representing one of the leading causes of death in intensive care units (ICUs) worldwide. Gut microbiota disruption is increasingly recognized as a key driver of persistent inflammation and multiple organ dysfunction in septic patients. Fecal microbiota transplantation (FMT) has emerged as a promising approach to restore gut microbial homeostasis. This study hypothesizes that FMT acts not through long-term engraftment of donor microbes, but via a \"functional pulse\" - a potent, transient biological intervention that delivers high-dose microbial metabolites (e.g., short-chain fatty acids), competitively inhibits pathogens, and rapidly modulates intestinal immune cell functions.\n\nThis is a single-center, open-label, randomized controlled trial conducted in the ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. A total of 60 adult patients diagnosed with sepsis according to Sepsis-3 criteria within 24 hours of ICU admission will be randomized in a 1:1 ratio to receive either ICU standard care alone (control group) or ICU standard care plus FMT administered via a nasojejunal tube for three consecutive days (intervention group). The primary endpoint is all-cause mortality at 90 days. Secondary endpoints include ICU mortality, in-hospital mortality, 28-day mortality, changes in gut microbiota composition and metabolites, serum citrulline levels as a marker of intestinal barrier function, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, vasopressor requirements, C-reactive protein and procalcitonin levels, fluid balance, incidence of ICU delirium and feeding intolerance, and 90-day hospital readmission rate. Safety outcomes include gastrointestinal symptoms and transient fever.",[26,90,236,94,237],"Gastrointestinal Dysfunction","Fecal Microbiota Transplantation",{"date":154,"type":35},{"date":100,"type":22},{"date":241,"type":22},"2028-10-15",{"name":104,"class":42},{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":4},"100616741","the-extended-study-of-prevalence-of-infection-in-intensive-care-iv-100616741","NCT07309549","The Extended Study of Prevalence of Infection in Intensive Care IV","The Extended Study of Prevalence of Infection in Intensive Care IV (EPIC IV)","EPIC IV","Inclusion Criteria:\n\n* All adult patients (\\>18 years) treated in the participating ICUs on the study day.\n\nExclusion Criteria:\n\n* Patients under 18 years",{"count":252,"type":22},10000,"The goal of this observational study is to learn how common infections are in intensive care units (ICUs) around the world and how they are treated. The study will look at all adults in the ICU during a single 24-hour period. The main questions it aims to answer are:\n\n* What types of infections and antibiotic-resistant bacteria are most common in ICUs worldwide?\n* How do resistance patterns affect how participants are treated and how they recover?\n\nHow are antibiotics used in ICUs, and how do hospitals practice antibiotic stewardship?\n\n* What organ support treatments do participants with infections receive?\n* What are the outcomes of participants with severe infections, including survival at hospital discharge (up to 60 days)?\n\nResearchers will compare ICUs across regions and income levels to see how infection patterns, treatments, and outcomes differ around the world.\n\nParticipants will:\n\n* Be counted if they are present in the ICU at any time during the study day.\n* Have information collected from their medical record about their health, the infection they may have, treatments they receive, and their outcome at ICU and hospital discharge (up to 60 days).\n\nBecause this is an observational study, participants will not receive any new treatments as part of the study.",[26,255],"Infection",[257,90,258,259,260,261],"Intensive Care Unit","Severe Infection","Organ Dysfunction","ICU Outcomes","Global Prevalence","2026-06-24",{"date":156,"type":35},{"date":265,"type":22},"2027-02-01",{"date":267,"type":22},"2027-06",{"name":269,"class":42},"Universidad de la Sabana",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":85,"enrollmentInfo":277,"targetDuration":4,"studyType":140,"phases":279,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":297},"100581771","phase-1-a-study-to-learn-about-how-safe-bay-3389934-is-its-suitable-dose-and-how-it-affects-the-participants-with-sepsis-induced-coagulopathy-100581771","NCT06854640","A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy","First in Patient, Dose Escalation, Open Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion of BAY 3389934 to Patients With Sepsis Induced Coagulopathy","Inclusion Criteria:\n\n* Participant must be ≥ 18 and ≤ 80 years of age at the time of signing the informed consent.\n* Participants with diagnosed sepsis according to sepsis-3 criteria. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.\n* participants with suspected or documented origin of infection.\n* Participants with coagulopathy defined by at least one of the following within 24 hours prior start of study intervention: INR ≥1.40, platelet count in the range of ≥ 30,000\u002Fmm3 to \\\u003C 150,000\u002Fmm3 OR greater than 30% decrease in platelets in 24 hours without other known etiology. The platelet count after decrease should not be \\\u003C 30,000\u002Fmm3.\n* Participants must be receiving treatment in an ICU.\n* Informed consent of capable participant or, in case of participant being incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations.\n\nExclusion Criteria:\n\n* Clinically significant active bleeding; known bleeding disorder, history of major traumatic or non-traumatic bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months.\n* Low platelets level or abnormal coagulation status due to any other reason than sepsis.\n* Participants with indication for therapeutic dose of: anticoagulation (heparin, argatroban, vitamin K antagonists\u002Fwarfarin, dabigatran, apixaban, rivaroxaban, edoxaban), oral antiplatelet agents (clopidogrel, ticagrelor, ticlopidine, prasugrel) except low dose (≤100mg) acetyl salicylic acid (ASA), digoxin, metformin\n* Any active malignancy\n* Pregnancy or breastfeeding.\n* Chronic liver disease Child-Pugh Class C.\n* Participants experienced major surgery or major trauma (intrathoracic, intra-abdominal, pelvic or femur) or surgery\u002Ftrauma in any other area with potentially clinically significant consequences due to bleeding within 28 days before study drug administration.\n* Participants experienced neurotrauma or neurosurgery (brain, spine) or orthopedic surgery in spine within 6 months before study drug administration",{"count":278,"type":22},36,[280],"PHASE1","Researchers are looking for a better way to treat people who have sepsis induced coagulopathy.\n\nSepsis happens when bacteria and their toxins spread in the blood, causing an infection. To overcome the infection the body responds activating the immune system, sometimes this immune response is too active and causes uncontrolled blood clot formation, also called sepsis-induced coagulopathy. Sepsis coagulopathy damages blood vessels and organs and leads to low platelet levels in the body. In severe cases, it can even lead to death.\n\nThe main purpose of this first in patient study is to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy. For this study, researchers will enroll people receiving treatment for sepsis induced coagulopathy in a hospital intensive care unit (ICU).\n\nFor this, the researchers will collect the number of participants with medical problems during and after receiving BAY 3389934. These medical problems are also known as \"adverse events\". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.\n\nParticipants will be divided into 2 groups. The first group will receive the lowest starting dose of BAY3389934. The researcher will carefully monitor how the participant responds to the medication and may adjust the dose, either increasing or decreasing it based on the safety and the tolerability of the drug. If no serious side effects are reported from the first group, the second group will receive higher dose of BAY3389934.\n\nEach participant will be in the study for around 28 days. During the study, the doctors and their study team will:\n\n* Take blood and urine samples,\n* Do physical examinations,\n* Check vital signs such as body temperature, blood pressure and heart rate,\n* Examine heart health using electrocardiogram (ECG)",[26,283],"Coagulopathy",[285,286,287],"DIC","Disseminated intravascular coagulation","Sepsis induced coagulopathy","2026-06-22",{"date":290,"type":35},"2026-06-23",{"date":292,"type":35},"2025-03-12",{"date":294,"type":22},"2027-02-15",{"name":296,"class":194},"Bayer",20,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":85,"enrollmentInfo":306,"targetDuration":4,"studyType":140,"phases":308,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":322},"100609524","phase-2-a-study-to-investigate-the-efficacy-safety-and-tolerability-of-azd4144in-participants-with-sepsis-associated-acute-kidney-injury-100609524","NCT07215702","A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury.","A Phase IIa, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants With Sepsis-associated Acute Kidney Injury (SERENIA)","SERENIA","Inclusion Criteria Age ≥ 18 to ≤ 80 years at the time of signing the informed consent. Participants who are admitted to an ICU or an equivalent critical-care unit.\n\nDiagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on:\n\nA. Suspected or confirmed bacterial infection AND B. Acute increase of mSOFA score of 2 or more excluding renal component (change in score measured to account for participants that may meet mSOFA criteria from pre-existing organ dysfunction before the onset of infection).\n\nHaemodynamic therapy:\n\nA. 30 mL\u002Fkg or clinically appropriate volume resuscitation prior to randomisation.\n\nB. Vasopressor and\u002For inotrope therapy for sepsis-induced hypotension (eg, norepinephrine \\[noradrenaline\\], epinephrine \\[adrenaline\\], phenylephrine, dopamine, dobutamine) for ≥ 4 hours.\n\nDiagnosis of AKI, within 72 hours of sepsis diagnosis, with modified KDIGO Stage ≥ 1, defined as: Increase in SCr to ≥ 1.5 × baseline (outpatient \\[preferred\\] or admission pre-AKI reference). Timing of AKI diagnosis is defined as the time that the initial qualifying SCr was reported. AKI must persist after completion of initial volume resuscitation (30 mL\u002Fkg or as clinically indicated per investigator discretion).\n\nOutpatient pre-AKI reference eGFR ≥ 30 mL\u002Fmin\u002F1.73 m2, if available within 2 weeks to 12 months prior to admission (preferred). If not available, admission pre-AKI reference eGFR ≥ 45 mL\u002Fmin\u002F1.73 m2 .\n\nBody weight ≥ 40 kg or ≤ 125 kg. Female or male, assigned at birth, inclusive of all gender identities. All FOCBP must have a negative pregnancy test at the Screening visit (Visit 1).\n\nContraception:\n\nA. Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods detailed in CSP from the time of first administration of study intervention administration until 100 days after the last dose of study intervention.\n\nB. FOCBP must not be lactating and must agree to use an approved method of highly effective contraception, as detailed in the CSP from the time of first administration of study intervention until 100 days after last dose of study intervention.\n\nCapable of giving signed informed consent (participant or LAR). Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics initiative research.\n\nExclusion Criteria Any clinical evidence which in the investigator's opinion makes it undesirable for the potential participant to enrol in the study.\n\nKnown history of Stage 4 or 5 CKD with documented sustained eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 prior to hospital admission.\n\nSepsis diagnosed \\> 7 days after hospital admission (to include from time of outside admission if patient transferred from another healthcare setting).\n\nAKI attributed to causes other than sepsis, including but not limited to compromised renal perfusion-related causes (surgical complication, acute abdominal aortic aneurysm, dissection, renal artery stenosis, etc), glomerular disease, acute interstitial nephritis, and medication toxicity.\n\nEvidence of recovery from AKI prior to randomisation defined as:\n\nA. A reduction of SCr to less than 1.5 times reference SCr in the last available local SoC laboratory result before randomisation or B. A \\> 25% reduction in SCr from peak SCr after volume resuscitation prior to randomisation.\n\nExpected survival from sepsis \\\u003C 24 hours. Expected survival \\\u003C 90 days due to chronic or pre-existing medical conditions other than SA-AKI Known history of renal transplant or bilateral nephrectomy. Permanent incapacitation. Incapacitation is defined as the inability to independently perform tasks essential to personal health and\u002For safety.\n\nActive cancer or cancer in remission for less than 2 years. Known history of immunodeficiency disease or currently receiving immunosuppressant therapy for non-sepsis related disease.\n\nSevere burns requiring ICU treatment. Sepsis attributed to confirmed or presumed fungal or viral infection at time of Screening.\n\nHas advanced chronic liver disease, confirmed by a Child-Pugh score of 10-15 (Class C).\n\nKnown history of cerebrovascular accident within the last 90 days. Known history of heart failure with reduced ejection fraction with documented ejection fraction ≤ 20% before sepsis diagnosis.\n\nKnown hypersensitivity to iohexol or known history of severe adverse reaction to iodinated contrast media.\n\nParticipants with known medical or psychological condition(s), or who, in the judgement of the investigator, should not participate in the study if they are unlikely to comply with study procedures, restrictions, and requirements.\n\nCurrent KRT (eg, continuous haemofiltration and haemodialysis\u002Fcontinuous kidney replacement therapy, intermittent haemodialysis, and peritoneal dialysis) or planned KRT (meaning KRT is scheduled, or the decision to initiate KRT has been made by the treating physician) at randomisation.\n\nCurrently receiving active treatment for malignancy.\n\nPotential participants will be excluded if they have received a certain class of medication during the weeks before enrollment or are anticipated to require a specific class of medication during the trial duration.\n\nParticipants with a known hypersensitivity to AZD4144 or any of the excipients of the product.\n\nReceipt of another IMP within 30 days, 5 half-lives, or the time frame of expected PD effect from most recent dose, whichever is longest.\n\nPrevious receipt of AZD4144. Active or planned treatment of sepsis with an extracorporeal haemoperfusion device.\n\nParticipation in any other concurrent ICU study which could impact participant clinical outcomes and confound results of this study to, including but not limited to volume resuscitation, vasopressor, or mechanical ventilation studies.\n\nPresence of anuria (≥ 12 hours) at randomisation. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG, at Screening, as judged by the investigator.\n\nProlonged QTcF \\> 470 ms. Known history of QT prolongation associated with other medications that required discontinuation of that medication.\n\nCongenital long QT syndrome. Known history of ST-elevation myocardial infarction or non-ST-elevation myocardial infarction, with or without intervention by percutaneous coronary intervention or coronary artery bypass grafting within the last 90 days.\n\nVentricular arrhythmia requiring treatment. Known or presumed latent or active tuberculosis. Acute pancreatitis with no established source of infection. Undergoing extracorporeal membrane oxygenation (ECMO) at randomisation. Neutropenia: ANC \\\u003C 1.5 × 109\u002FL. Admitting diagnosis of rhabdomyolysis. Admitting diagnosis of trauma with CK \\> 15000 U\u002FL. Presumed nidus of infection in central nervous system. Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n\nPrevious randomisation in the present study. For females only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.\n\nFirst infusion of IMP unable to be started within 36 hours of AKI diagnosis. Presence of a do-not-resuscitate order.",{"count":307,"type":22},124,[309],"PHASE2","This study will enroll adults aged 18 to 80 years diagnosed with sepsis due to a suspected or confirmed bacterial infection, within 7 days of being admitted to the hospital, and who have also developed acute kidney injury within 72 hours of the onset of sepsis. Eligible participants will be randomly assigned to receive either AZD4144 or a placebo intravenously once daily for the number of days specified in the CSP. During this Treatment Period, participants will undergo daily safety monitoring, as well as blood and urine sample collection and other assessments. After the Treatment Period, participants will continue to be monitored for safety and other assessments during each additional day they remain hospitalized (if applicable) as well as during up to 2 follow up visits after discharge. The main goal is to compare specific kidney function measurements between those participants receiving AZD4144 and those receiving the placebo.",[26,312],"Acute Kidney Injury",[26,312],"2026-06-19",{"date":290,"type":35},{"date":317,"type":35},"2026-02-10",{"date":319,"type":22},"2027-02-11",{"name":321,"class":194},"AstraZeneca",72,{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":85,"enrollmentInfo":330,"targetDuration":332,"studyType":23,"phases":4,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":343,"leadSponsor":345,"locationsCount":4},"100644180","myeloid-bias-in-the-bone-marrow-of-septic-patients-and-its-correlation-with-disease-severity-and-prognosis-a-single-center-prospective-cohort-study-100644180","NCT07667153","Myeloid Bias in the Bone Marrow of Septic Patients and Its Correlation With Disease Severity and Prognosis: A Single-Center, Prospective Cohort Study","Myeloid Bias in the Bone Marrow of Septic Patients","1\\. Inclusion Criteria\n\n(1) Sepsis-Associated Critical Illness Cohort\n\n* Age 18-80 years, both genders;\n* Meets the Sepsis-3.0 criteria: confirmed or suspected infection with an acute increase in SOFA score of ≥2 points;\n* Admitted to the intensive care unit (ICU) for 48-72 hours at the time of enrolment;\n* Expected ICU length of stay ≥7 days;\n* Written informed consent provided by the patient or their legally authorized representative.\n\n  (2) Non-Septic Critical Illness Cohort\n* Age 18-80 years, both genders;\n* Admitted to the ICU for 48-72 hours with a diagnosis of non-infectious critical illness, including but not limited to: (a) severe acute pancreatitis; (b) major trauma (Injury Severity Score ≥16); (c) post-major surgery (e.g., cardiovascular surgery, hepatectomy); (d) acute cerebrovascular disease (ischaemic stroke, intracerebral haemorrhage); (e) other critical conditions requiring ICU support;\n* Expected ICU length of stay ≥7 days;\n* Written informed consent provided by the patient or their legally authorized representative.\n\n  (3) Healthy Volunteer Control Cohort\n* Age 18-80 years, both genders.\n* No acute or chronic medical history; recent health check-up results are normal.\n* Normal complete blood count: white blood cell count, haemoglobin, and platelet count within the normal reference ranges;\n* Willing and able to provide written informed consent.\n\n  2\\. Exclusion Criteria\n\n  (1) Sepsis-Associated Critical Illness Cohort\n* Haematological disorders: previous or current primary haematological diseases affecting bone marrow haematopoiesis, including leukaemia, myelodysplastic syndromes, aplastic anaemia, multiple myeloma, lymphoma, etc;\n* Active malignancy or receipt of chemotherapy\u002Fradiotherapy within the past 3 years;\n* Immunosuppressed state: (a) use of immunosuppressive agents within the past 3 months (including glucocorticoids ≥0.5 mg\u002Fkg\u002Fday for ≥2 weeks); (b) history of solid organ or haematopoietic stem cell transplantation; (c) HIV infection or AIDS; (d) congenital immunodeficiency;\n* Blood transfusion or bone marrow transplantation within the past 3 months;\n* Severe chronic organ dysfunction: (a) Child-Pugh Class C liver disease; (b) end-stage renal disease (eGFR \\\u003C30 mL\u002Fmin) without regular dialysis;\n* Abnormalities at the puncture site: infection, rash, trauma, or anatomical deformity at the posterior superior iliac spine;\n* Pregnancy or breastfeeding;\n* Moribund state with expected survival \\\u003C24 hours;\n* Participation in another interventional clinical trial within 3 months before or at enrolment;\n* Refusal to sign informed consent by the patient or legal representative.\n\n  (2) Non-Septic Critical Illness Cohort\n* Evidence of infection: confirmed or suspected active infection (including pneumonia, intra-abdominal infection, urinary tract infection, bloodstream infection, etc.) within 48 hours of ICU admission;\n* All other exclusion criteria listed for the Sepsis-Associated Critical Illness Cohort (items 1-10) apply.\n\n  (3) Healthy Volunteer Control Cohort\n* History of infection within the past 1 month;\n* Abnormalities at the puncture site: infection, rash, trauma, or anatomical deformity at the posterior superior iliac spine;\n* Pregnancy or breastfeeding.",{"count":331,"type":22},45,"90 Days","Sepsis remains a leading cause of critical illness worldwide, yet the underlying mechanisms driving its profound and persistent immune dysfunction are incompletely understood. The bone marrow, as the birthplace of all immune cells, plays a central role in orchestrating systemic immune responses. Emerging evidence from animal models suggests that sepsis triggers emergency myeloid-biased hematopoiesis in the bone marrow, characterized by expansion of myeloid progenitors and myeloid-derived suppressor cells (MDSCs) at the expense of lymphoid and erythroid lineages. This bone marrow remodeling precedes peripheral immune alterations and may represent the initiating event of sepsis-induced immunosuppression. However, direct clinical evidence in humans is scarce. This prospective, single-center cohort study aims to systematically characterize bone marrow hematopoietic remodeling in patients with septic shock, compared to critically ill non-septic patients and healthy volunteers, and to determine whether the degree of myeloid lineage bias correlates with disease severity, immunosuppression, and adverse clinical outcomes.\n\nThis study will enroll three cohorts. Bone marrow aspirates and peripheral blood samples will be collected at 48-72 hours post-enrollment for flow cytometric immunophenotyping of hematopoietic stem\u002Fprogenitor cells, MDSC subsets, and PD-L1 expression, as well as cytokine profiling and exploratory single-cell transcriptomics. Rectal swabs will be collected synchronously for 16S rRNA sequencing and untargeted metabolomics to investigate the association between gut microbiota, microbial metabolites, and bone marrow myeloid skewing, testing the gut-bone marrow-immune axis hypothesis. Clinical severity (SOFA\u002FAPACHE II), secondary infections, and 90-day mortality will be assessed to evaluate prognostic value. By integrating bone marrow hematopoiesis, gut microbiome, and clinical outcomes, this study seeks to provide novel mechanistic insights into sepsis-induced immunoparalysis and identify potential biomarkers or therapeutic targets for immune restoration.",[26,335],"Septic Shock",[26,337,338,339],"Bone marrow","Myeloid bias","Prognosis","2026-06-18",{"date":262,"type":35},{"date":100,"type":22},{"date":344,"type":22},"2027-12-30",{"name":104,"class":42},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":18,"minAge":353,"maxAge":55,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":4},"100644464","cbc-indices-and-serum-lactate-in-neonatal-sepsis-100644464","NCT07663084","CBC Indices and Serum Lactate in Neonatal Sepsis","Diagnostic and Prognostic Values of CBC Indices and Serum Lactate in Neonatal Sepsis","Inclusion Criteria:\n\n* Neonates aged 0 to 28 days (term and preterm).\n* Presence of two or more clinical signs highly suggestive of sepsis (e.g., temperature instability \\[\\\u003C 36.5°C or \\> 37.5°C\\], tachycardia\u002Fbradycardia, tachypnea, feeding intolerance, lethargy, or altered muscle tone).\n* Informed written consent obtained from the parents or legal guardians.\n\nExclusion Criteria:\n\n* Neonates with severe congenital anomalies or chromosomal abnormalities.\n* Neonates diagnosed with Inborn Errors of Metabolism (which inherently alter lactate levels).\n* Neonates with severe perinatal asphyxia or Hypoxic-Ischemic Encephalopathy (HIE), as these conditions cause profound primary lactic acidosis independent of sepsis.\n* Neonates who received prior broad-spectrum intravenous antibiotics for more than 24 hours prior to admission.\n* Neonates who have received prior blood transfusions.\n* Neonates requiring immediate surgical intervention.","0 Days",{"count":355,"type":22},80,"Neonatal sepsis is a leading cause of illness and death in Neonatal Intensive Care Units (NICUs). Diagnosing it quickly is challenging because the early signs often overlap with other common newborn health issues. While a blood culture is the most accurate way to confirm an infection, the results can take 48 to 72 hours. This delay highlights the need for faster, more accessible diagnostic tools.\n\nThis observational study aims to find quicker ways to diagnose neonatal sepsis and predict its severity using readily available blood tests. Researchers are investigating whether specific details from a standard Complete Blood Count (CBC), such as the variation in red blood cell size (RDW), the average size of platelets (MPV), and the ratio of immature to total white blood cells (I\u002FT ratio), combined with serum lactate levels (a marker of tissue oxygenation and stress) can serve as reliable, early warning signs.\n\nThe study will enroll newborns (0 to 28 days old) admitted to the NICU who show clinical signs of a possible infection. Upon admission and before starting any antibiotic treatment, a small blood sample will be drawn to measure these CBC indices and serum lactate, alongside the standard blood culture.\n\nBy comparing these rapid blood test results with the final blood culture outcomes and the infants' overall clinical progress in the NICU, the research team hopes to determine if this simple combination of markers can help doctors diagnose sepsis earlier, anticipate the severity of the illness, and make faster, life-saving treatment decisions.",[358,26],"Neonatal Sepsis",[358,360,361,362,363,364,365,339],"Complete Blood Count Indices","Serum Lactate","Mean Platelet Volume","Immature-to-Total Neutrophil Ratio","Red Cell Distribution Width","Diagnostic Biomarkers","2026-06-17",{"date":290,"type":35},{"date":369,"type":22},"2026-08",{"date":371,"type":22},"2027-09",{"name":373,"class":42},"Assiut University",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":382,"targetDuration":4,"studyType":140,"phases":383,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":405,"locationsCount":129},"100641107","effects-of-anisodamine-on-sublingual-microcirculation-and-vascular-waterfall-phenomenon-in-patients-with-septic-shock-100641107","NCT07657702","Effects of Anisodamine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock","Effects of Anisodamine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective, Multicenter, Single-arm, Open-label, Pilot Physiological Study","ANISO-MICRO","Inclusion Criteria:\n\n* Age 18-85 years.\n* Diagnosis of septic shock according to Sepsis-3 criteria, defined as suspected or documented infection with vasopressor requirement to maintain mean arterial pressure ≥65 mmHg and serum lactate \\>2 mmol\u002FL after adequate fluid resuscitation.\n* Enrollment within 24 hours after diagnosis of septic shock or within 24 hours after ICU admission for septic shock.\n* Receiving invasive mechanical ventilation at the time of enrollment.\n* PiCCO catheter in place and PiCCO-based hemodynamic monitoring available before anisodamine initiation.\n* Continuous norepinephrine infusion at enrollment.\n* Adequate initial fluid resuscitation and hemodynamic optimization as judged by the treating physician, with volume status assessed by dynamic indices, echocardiography, or PiCCO-derived variables.\n* Ability to obtain sublingual microcirculatory images of acceptable quality at baseline.\n* Written informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n* Shock mainly caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.\n* Expected death or withdrawal of life-sustaining treatment within 24 hours.\n* Known contraindications to anisodamine or anticholinergic therapy, including glaucoma, acute phase of intracranial hemorrhage, elevated intracranial pressure, untreated bowel obstruction, or prostatic enlargement without urinary catheterization.\n* Known allergy or hypersensitivity to anisodamine or any component of the study drug.\n* Severe or uncontrolled arrhythmia before enrollment, including sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, uncontrolled supraventricular tachycardia, or atrial fibrillation\u002Fflutter with uncontrolled ventricular response.\n* Acute coronary syndrome, clinically significant myocardial ischemia, or cardiac arrest before enrollment during the current ICU stay.\n* Severe cardiac dysfunction judged unsuitable for anisodamine by the treating physician, including severe ventricular dysfunction, cardiogenic shock, or need for high-dose inotropic support.\n* Conditions interfering with sublingual microcirculatory assessment, including major oral or sublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.\n* Immunocompromised status or agranulocytosis, including long-term immunosuppressive therapy, chemotherapy-associated severe neutropenia, or other severe immune suppression judged by the investigator.\n* Pregnancy, planned pregnancy, or lactation.\n* Participation in another interventional clinical trial that may affect study outcomes or safety.\n* Inability to obtain informed consent.",{"count":297,"type":22},[142],"This prospective, multicenter, single-arm, open-label interventional pilot study aims to evaluate the short-term physiological effects of intravenous anisodamine on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock.\n\nEligible patients will have septic shock according to Sepsis-3 criteria, will require norepinephrine support after adequate fluid resuscitation, and will be receiving invasive mechanical ventilation and PiCCO-based hemodynamic monitoring. After baseline assessment, participants will receive intravenous anisodamine according to the study protocol. Anisodamine will be administered as a loading dose of 0.5 mg\u002Fkg within 3 minutes, with a minimum dose of 20 mg and a maximum dose of 40 mg, followed by continuous infusion at 0.02-0.1 mg\u002Fkg\u002Fhour, with a maximum total daily dose of 200 mg.\n\nSublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline, 3 hours, and 6 hours after initiation of anisodamine. Systemic hemodynamic, perfusion, vasopressor, PiCCO-derived variables, and safety outcomes will also be collected.\n\nThe primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after anisodamine administration and to provide preliminary data for future controlled studies.",[335,26,90],[387,388,389,390,391,392,393,394,395,396,397,398,399],"anisodamine","anisodamine hydrobromide","septic shock","sublingual microcirculation","microvascular flow index","vascular waterfall","critical closing pressure","mean systemic filling pressure","Pcc","Pmsf","PiCCO","mechanical ventilation","arrhythmia","2026-06-14",{"date":340,"type":35},{"date":403,"type":22},"2026-08-01",{"date":344,"type":22},{"name":406,"class":42},"First Affiliated Hospital of Wannan Medical College",{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":414,"targetDuration":4,"studyType":140,"phases":415,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":423,"leadSponsor":424,"locationsCount":425},"100641364","effects-of-esmolol-on-sublingual-microcirculation-and-vascular-waterfall-phenomenon-in-patients-with-septic-shock-100641364","NCT07657754","Effects of Esmolol on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock","Effects of Esmolol on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective, Multicenter, Single-arm, Open-label, Pilot Physiological Study","Inclusion Criteria:\n\nAge 18-85 years. Diagnosis of septic shock according to Sepsis-3 criteria, requiring norepinephrine to maintain MAP ≥65 mmHg after adequate fluid resuscitation.\n\nPersistent tachycardia after initial hemodynamic optimization, adequate analgesia\u002Fsedation, and correction of reversible causes, defined as heart rate ≥95 beats\u002Fmin.\n\nContinuous norepinephrine infusion for ≥6 hours, with norepinephrine dose ≥0.10 μg\u002Fkg\u002Fmin at enrollment.\n\nAdequate volume status or absence of fluid responsiveness assessed by dynamic indices, echocardiography, or advanced hemodynamic monitoring; if PiCCO is used, GEDVI \\>700 mL\u002Fm² and\u002For ITBVI \\>850 mL\u002Fm² may be used as supportive criteria.\n\nPreserved or hyperdynamic cardiac function before esmolol initiation, defined as cardiac index \\>3.0 L\u002Fmin\u002Fm² or absence of severe septic cardiomyopathy.\n\nAbility to obtain sublingual microcirculatory images of acceptable quality at baseline.\n\nWritten informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\nShock mainly caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.\n\nSevere cardiac dysfunction or severe septic cardiomyopathy, including cardiac index \\\u003C2.2 L\u002Fmin\u002Fm² despite adequate preload, severe ventricular dysfunction, or need for inotropic agents at enrollment.\n\nUse of β-blockers before ICU admission or within 24 hours before enrollment. Contraindications to esmolol or β-blockade, including high-grade atrioventricular block without pacing, severe bradycardia, sick sinus syndrome, severe bronchospasm\u002Fasthma, or known allergy to esmolol.\n\nSevere structural heart disease or major pulmonary conditions affecting hemodynamics or safety, including severe valvular disease, significant congenital heart disease, cardiomyopathy, severe pulmonary bullae, or untreated pneumothorax.\n\nAcute coronary syndrome, life-threatening arrhythmia, or cardiac arrest before enrollment during the current ICU stay.\n\nConditions interfering with sublingual microcirculatory assessment, including major oral\u002Fsublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.\n\nPregnancy or lactation, expected death or withdrawal of life-sustaining treatment within 24 hours, expected ICU stay \\\u003C48 hours, or inability to obtain informed consent.",{"count":297,"type":22},[142],"This prospective, multicenter, single-arm interventional pilot study aims to evaluate the short-term physiological effects of intravenous esmolol on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock. Eligible patients will have septic shock according to Sepsis-3 criteria, persistent tachycardia after initial hemodynamic optimization, ongoing norepinephrine support, adequate volume status or absence of significant fluid responsiveness, and preserved or hyperdynamic cardiac function.\n\nApproximately 20 patients will be enrolled from participating intensive care units. After baseline assessment, participants will receive continuous intravenous esmolol infusion according to the study protocol and clinical safety criteria. Sublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline and at 3, and 6 hours after esmolol initiation. Additional systemic hemodynamic, perfusion, vasopressor, and safety variables will also be collected.\n\nThe primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after esmolol administration and to provide preliminary data for the design of future controlled studies.",[335,26,418],"Critical Illness Sepsis, Severe",[420,390,391,393,394,392,335],"esmolol",{"date":340,"type":35},{"date":403,"type":22},{"date":344,"type":22},{"name":406,"class":42},2,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":434,"targetDuration":4,"studyType":140,"phases":435,"briefSummary":436,"conditions":437,"keywords":438,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":446,"leadSponsor":447,"locationsCount":425},"100641303","effects-of-dexmedetomidine-on-sublingual-microcirculation-and-vascular-waterfall-phenomenon-in-patients-with-septic-shock-100641303","NCT07657715","Effects of Dexmedetomidine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock","Effects of Dexmedetomidine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective, Multicenter, Single-arm, Open-label, Pilot Physiological Study","DEX-MICRO","Inclusion Criteria:\n\n* Age 18-85 years.\n* Diagnosis of septic shock according to Sepsis-3 criteria, defined as suspected or documented infection with vasopressor requirement to maintain mean arterial pressure ≥65 mmHg and serum lactate \\>2 mmol\u002FL after adequate fluid resuscitation.\n* Enrollment within 24 hours after diagnosis of septic shock in the ICU.\n* Receiving invasive mechanical ventilation.\n* Receiving continuous intravenous sedative and\u002For analgesic therapy other than dexmedetomidine before enrollment, with a clinical decision to add dexmedetomidine for sedation management.\n* Continuous norepinephrine infusion at enrollment.\n* PiCCO catheter in place and PiCCO-based hemodynamic monitoring available before dexmedetomidine initiation.\n* Written informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n* Shock primarily caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.\n* Expected death or withdrawal of life-sustaining treatment within 24 hours.\n* Known allergy or hypersensitivity to dexmedetomidine.\n* Severe bradycardia or clinically significant conduction abnormality before enrollment, including heart rate \\\u003C50 beats\u002Fmin, second-degree or third-degree atrioventricular block, sick sinus syndrome, or other conduction abnormality without a functioning pacemaker.\n* Severe uncontrolled arrhythmia, acute coronary syndrome, or clinically significant myocardial ischemia before enrollment.\n* Severe hemodynamic instability judged unsuitable for dexmedetomidine by the treating physician, including refractory hypotension or rapidly escalating vasopressor requirement.\n* Severe hepatic dysfunction judged by the investigator to substantially increase the risk of dexmedetomidine accumulation or adverse effects.\n* Conditions interfering with sublingual microcirculatory assessment, including major oral or sublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.\n* Pregnancy or lactation.\n* Participation in another interventional clinical trial that may affect study outcomes or safety.",{"count":297,"type":22},[142],"This prospective, multicenter, single-arm, open-label interventional pilot study aims to evaluate the short-term physiological effects of intravenous dexmedetomidine on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock.\n\nEligible patients will have septic shock according to Sepsis-3 criteria, require norepinephrine support after adequate fluid resuscitation, receive invasive mechanical ventilation, and have PiCCO-based hemodynamic monitoring available before dexmedetomidine initiation. After baseline assessment, participants will receive intravenous dexmedetomidine according to the study protocol. Dexmedetomidine will be administered as a continuous intravenous infusion at 0.2-0.7 µg\u002Fkg\u002Fhour without a loading dose. The infusion rate may be adjusted according to the target sedation level, hemodynamic status, and adverse effects.\n\nSublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline, 3 hours, and 6 hours after initiation of dexmedetomidine. Systemic hemodynamic, perfusion, vasopressor, PiCCO-derived, sedation-related, and safety outcomes will also be collected.\n\nThe primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after dexmedetomidine administration and to provide preliminary data for future controlled studies.",[335,26,90],[439,389,390,391,392,393,394,395,396,397,398,440,441,442,443],"dexmedetomidine","sedation","bradycardia","hypotension","norepinephrine",{"date":340,"type":35},{"date":403,"type":22},{"date":344,"type":22},{"name":406,"class":42},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":455,"enrollmentInfo":456,"targetDuration":4,"studyType":140,"phases":457,"briefSummary":458,"conditions":459,"keywords":460,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":466,"locationsCount":129},"100641480","extracorporeal-cfdna-removal-in-septic-shock-patients-with-elevated-dna-levels-100641480","NCT07657767","Extracorporeal cfDNA Removal in Septic Shock Patients With Elevated DNA Levels","Extracorporeal cfDNA Removal in Septic Shock Patients With Elevated DNA Levels.","Inclusion Criteria:\n\n* The age of patients is 18-65 years,\n* Septic shock (Sepsis-3 criteria) with dependence on vasopressor and\u002F or sympathomimetic therapy (norepinephrine - more than 0.05 mcg \u002F kg\u002Fmin, adrenaline - more than 0.05 mcg \u002F kg\u002Fmin), persisting after correction of hypovolemia.\n* concentration of cfDNA in the bloodstream is greater than its prognostically unfavorable level, determined by the fluorimetric method, or the presence of predictors of a prognostically unfavorable level of cfDNA: the concentration of mixed venous blood lactate is more than 1.9 mmol\u002Fl, the number of SOFA scores is more than 7\n\nExclusion Criteria:\n\n* Clinical death after the onset of sepsis;\n* An untreated surgical infection site;\n* History of transfusion-related acute lung injury;\n* Allergy to heparin, GIT in the anamnesis;\n* Uncontrolled bleeding or a high risk of its occurrence,\n* The presence of cardiovascular events within the last 2 months: AMI, stroke, PE, Severe congestive CHF;\n* Severe chronic congestive heart failure;\n* End-stage CKD;\n* Chronic use of immunosuppressive therapy;\n* HIV infection, Constant use of immunosuppressive therapy, severe granulocytopenia (WBC less than 500 cells \u002Fmm3),\n* Development of acute cardiovascular insufficiency characterized by hypotension (BP system. less than 60 mmHg) and\u002For bradycardia (heart rate less than 40 min -1), refractory to adrenaline (bolus of more than 100 micrograms or infusion of more than 300 mcg\u002Fkg\u002Fmin).","65 Years",{"count":232,"type":22},[142],"modern medicine, associated with profound morbidity and high mortality rates. As a clinical syndrome characterized by a dysregulated systemic response to infection, its progression toward life-threatening organ dysfunction is driven by an array of signaling molecules. Extracorporeal therapy has emerged as a key adjunctive strategy for the targeted elimination of these inflammatory mediators. While current modalities - including non-selective cytokine adsorption, selective LPS-adsorption, and therapeutic plasma exchange (TPE) - have shown clinical benefits in specific patient cohorts, research into more precise interventions continues.\n\nA new frontier focuses on the extracorporeal removal of cell-free DNA (cfDNA) and neutrophil extracellular traps (NETs), which recognized as pivotal drivers of systemic inflammation. This study evaluates the \"Nucleocor\" plasma adsorption column, a pioneering device designed for the selective removal of DNA-containing structures. By targeting septic shock patients with prognostically unfavorable cfDNA elevations, this research aims to establish standardized protocols and generate the evidence base necessary for integrating this novel therapy into national clinical guidelines.",[26],[118,389],"2026-06-13",{"date":340,"type":35},{"date":464,"type":22},"2026-06-10",{"date":265,"type":22},{"name":467,"class":42},"Sergey Savko",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":129},"100642242","evaluation-of-biomarkers-for-quick-sepsis-diagnosis---erased-study-100642242","NCT07655154","Evaluation of biomArkers for Quick SEpsis Diagnosis - ErASED Study","Inclusion Criteria:\n\n* All patients ≥18 years old meeting criteria for organ dysfunction identified as an acute change in total SOFA score ≥2 points.\n* At least one collected microbiological sample\n* Informed consent signed by patients or legal tutors.\n\nExclusion Criteria:\n\n* Patients with an history of recent traumatic injury.\n* Patients who refuse to sign the informed consent.",{"count":425,"type":22},"Since the \"Sepsis-3\" consensus statement in 2016, sepsis has been defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Recognition of sepsis is mostly based on clinical criteria. To aid diagnosis, a wide range of biomarkers has been identified, however, with few exceptions such as procalcitonin, none is part of the routine assessment of a septic patient. Proadrenomedullin, serum calprotectin and a score of combined values of IL-6 + IL-8 + IL-10 + MCP-1 have been proposed as biomarkers to aid diagnosis and predict prognosis in sepsis, but data about their kinetics and their correlation to mortality, organ dysfunction and microbiological diagnosis is still lacking. The aim is at prospectically studying their kinetics in clinically septic patients during the first hours of their presentation in our Emergency Department, with the aim of assessing their ability to distinguish sepsis from other causes of life-threatening organ dysfunction and disease severity. Patients will be thus divided in cases (culture-confirmed infection) and controls (patient without demonstrated cause of infection). Secondary objectives will evaluate the correlation between the biomarkers' values, mortality, admission to Intensive Care Unit and organ dysfunction. In patients with confirmed infection, moreover, we will correlate biomarkers with the etiological diagnosis. The expectetion is to be able to enrol at least 120 patients in 12 months. With this number of subjects, it will be possible to detect significant differences in the mean values of the biomarkers with a power of 90% and a type I error of 5%. Analyses will produce summary indicators to synthesize the kinetics of the biomarkers including area under the curve, percentage of time spent over a critical threshold (e.g., the 75th percentile of the values), and variability indicators such as standard deviation and difference between the last and the first value. Time series among groups will be analysed with standard statistical techniques such as repeated ANOVA and advanced temporal clustering techniques. For the secondary objectives will be used the Wilcoxon test with suitable post hoc strategies to correct for multiple comparisons.",[26],"2026-06-12",{"date":366,"type":35},{"date":480,"type":22},"2026-09",{"date":482,"type":22},"2030-09",{"name":484,"class":42},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":140,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":195},"100642234","self-directed-mobile-mindfulness-to-address-icu-survivors-psychological-distress-100642234","NCT07634419","Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress","Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress: Lift RCT (Lift 3)","Lift 3","Inclusion Criteria:\n\nInclusion criteria present during hospitalization\n\n1. Adult (age ≥18)\n2. Managed in an ICU for ≥24 hours during the time inclusion criterion #3 is met\n3. Serious acute cardiorespiratory condition, defined as ≥1 of the following:\n\n   * mechanical ventilation via endotracheal tube for ≥4 hours\n   * non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure\n   * new use of supplemental oxygen ≥6 liters per minute (or increase in baseline continuous oxygen)\n   * use of vasopressors for shock of any etiology\n   * use of inotropes for shock of any etiology\n   * use of pulmonary vasodilators\n   * use of aortic balloon pump or cardiac assist device for cardiogenic shock\n   * use of diuretic intravenous drip\n   * evidence of acute coronary ischemia (i.e., elevated troponin level, supporting EKG changes, unstable angina symptoms documented)\n   * urgent cardiac catheterization\n4. Cognitive status intact\n\n   o No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart\n5. Absence of severe and\u002For persistent mental illness\n\n   o Treatment for severe and\u002For persistent mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia \\[as per medical record\\], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission\n6. Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys)\n\nInclusion criteria present after hospital discharge (i.e., at the time of arrival home after discharge from the hospital):\n\n1\\. Elevated baseline psychological distress symptoms, defined as a PHQ-9 score ≥5\n\nExclusion Criteria:\n\nExclusion criteria present in the hospital:\n\n1\\. Discharged to a location other than a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)\n\nExclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital):\n\n1. Severe psychological distress as assessed by endorsement of active suicidality (see Protection of Human Subjects document for study team management of this finding)\n2. Failure to randomize within 1 month after discharge from the hospital to home\n3. Failure to login to study app and access content within 2 weeks after randomization",{"count":494,"type":22},450,[142],"Serious acute heart and lung illnesses like heart failure, severe COVID, and sepsis often leave survivors struggling not only physically, but also with lasting depression, anxiety, and stress. These problems that are hard to treat because access to mental health care is often limited. To help address this, the researchers created Lift, a fully automated mindfulness program designed with patient input and delivered through a mobile app. The investigators now plan a large, multi-site study to test whether Lift improves mental health and quality of life over six months compared to a critical illness education program called Enlighten Recovery. Overall the goal is to make an easy-to-use, widely accessible program available to people across the U.S., including those who speak Spanish.",[90,498,26,499,500,501],"Heart Failure","Ards","Pneumonia","Trauma Injury",{"date":503,"type":35},"2026-06-16",{"date":505,"type":22},"2026-06-01",{"date":507,"type":22},"2031-05-31",{"name":509,"class":42},"Duke University",{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":519,"conditions":520,"keywords":524,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":425},"100530991","icu-combined-assessment-of-cardio-respiratory-exercise-100530991","NCT06193980","ICU Combined Assessment of Cardio-Respiratory Exercise","Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness","ICU-CARE","Inclusion Criteria:\n\n* Patients who have received mechanical ventilation for at least 7 days in the intensive care unit (ICU) and have subsequently been discharged from hospital.\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Trajectory of health expected to be significantly limited in the upcoming 12 months\n* those who self-report that they cannot climb at least one flight of stairs due to limited exercise capacity\n* have significant orthopedic or musculoskeletal impairment affecting mobility\n* have a medical history of neuromuscular disease\n* ongoing respiratory limitations (i.e., supplemental oxygen)\n* significant heart disease (i.e. ejection fraction less than 30%, unstable ischemic heart disease, severe valvular heart disease)\n* a body mass index (BMI) of ≥ 40 kg\u002Fm2 (impacting NIRS signal due to adipose tissue thickness)\n* if participant's primary residence is a significant distance from the participating study site",{"count":172,"type":22},"This study aims to investigate how sepsis and critical illness can impair the cardiovascular system and microcirculation in intensive care unit (ICU) patients, which can lead to long-lasting muscle weakness\u002Fdysfunction or ICU-Acquired Weakness (ICU-AW) and exercise limitations.",[521,26,522,90,523],"ICU Acquired Weakness","Shock","Microcirculation",[525,526,523,527,528,529,530,531],"ICU Survivors","Oxygen Delivery","skeletal muscle","Exercise","near-infrared spectroscopy","cardiopulmonary exercise test","cardiovascular physiology","2026-06-11",{"date":534,"type":35},"2026-06-15",{"date":536,"type":35},"2023-12-15",{"date":538,"type":22},"2029-12",{"name":540,"class":42},"University of Manitoba",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":18,"minAge":548,"maxAge":549,"enrollmentInfo":550,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":552,"conditions":553,"keywords":554,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":567},"100642528","smart-discharges-for-older-children-100642528","NCT07629154","Smart Discharges for Older Children","Smart Discharges for Older Children: A Cohort Study to Develop Prognostic Algorithms for Post-discharge Readmission and Mortality Among Children Over 5 Years of Age","Inclusion Criteria:\n\n* Age between 0 and 16 years admitted to pediatric ward of hospital for proven or suspected infection\n* Provide informed consent\n* Ability to provide contact information (phone number or address) for phone or in-person follow-up\n\nExclusion Criteria:\n\n* Child lives outside of the catchment area of a study site\n* Admitted for elective procedures, trauma, or short-term observation\n* Language barriers","5 Years","16 Years",{"count":551,"type":22},4000,"This study is an observational multi-country cohort study that aims to build algorithms that can identify children between 5 and 16 years of age admitted for proven or suspected sepsis who are at risk of mortality after they are discharged in East Africa.\n\nIn low- and middle-income countries, about 5% of children discharged after hospitalization for sepsis will die in the weeks after returning home. Doctors and parents are often unaware of this period of vulnerability and are poorly equipped to identify or handle this critical situation. This project builds on past work that developed and evaluated models and the Smart Discharges program to predict, during hospitalization, an individual child's risk of recurrent illness and mortality, as well as to provide additional post-discharge support to at-risk children.\n\nParticipants will be enrolled from facilities once they are admitted, collecting clinical and social variables. They will then be followed until 6 months post-discharge to understand what happens to them after they return home. This data will be evaluated to identify which variables collected at facilities can be predictive of mortality and recurrent illness after discharge.",[26],[555,118,556,557,558,559],"pediatrics","risk-prediction","critical care","post-discharge","patient discharge",{"date":534,"type":35},{"date":562,"type":35},"2024-01-02",{"date":564,"type":22},"2027-04",{"name":566,"class":42},"University of British Columbia",7,{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":140,"phases":577,"briefSummary":578,"conditions":579,"keywords":581,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":297},"100311406","phase-2-prospective-randomized-trial-of-personalized-medicine-with-pentaglobin-after-surgical-infectious-source-control-in-patients-with-peritonitis-100311406","NCT03334006","Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis","PEPPER","Inclusion Criteria:\n\n1. The patient is diagnosed with secondary or quaternary peritonitis\n2. The time of the surgical infectious source control is within 6 hours of indication (defined as date and time of registration for surgical or minimal invasive procedure).\n3. Sepsis and \u002F or septic shock (according to the current sepsis guideline of the German Sepsis Society).\n4. SOFA Score ≥ 8\n5. The concentration of IL-6 is ≥ 1000 pg \u002F ml\n6. Treatment with antibiotics is started within 12 hours of admission to the Intensive Care Unit\n7. The informed consent form has been signed by the patient and \u002F or by his legal representative (such as his spouse, an health care proxy authorized or a legal representative) or by a consultant physician\n\nExclusion criteria\n\n1. Patients with a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis nor with sepsis and \u002F or septic shock.\n2. For female patients: The patient is pregnant or breastfeeding.\n3. The patient is a minor (\\\u003C 18 years of age).\n4. The patient has known chronic renal dysfunction requiring dialysis (creatinine ≥ 3.4 mg \u002F dl or creatinine clearance ≤ 30 mL\u002Fmin\u002F1.73 m²).\n5. The patient has acute, primarily non-infectious pancreatitis or mediastinitis.\n6. The patient has a BMI \\> 40.\n7. The patient has any contraindication to study drug.\n8. The patient has participated in another clinical trial within the last 30 days.\n9. The patient is in a dependent or employment relationship with the sponsor or investigator.\n10. The patient is institutionalized by court or government order.",{"count":576,"type":22},200,[309],"The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to\n\n1. Improvement of patient outcomes for peritonitis. Improvement in outcome will be determined by scores such as MOF, SOFA and survival.\n2. Identification of biomarkers (including immunoglobulin levels, HLA-DR, NF-kB1 and other immunological biomarkers) to identify patient subpopulations that benefit most from IgGAM treatment. These patients will form the basis for a further randomized, controlled, double-blind Phase III trial (RCT) to demonstrate the benefit of this treatment.\n3. In addition, these biomarkers could help to guide a targeted, i.e. \"personalized\", adjuvant therapy with Pentaglobin® (IgGAM) in the indication of peritonitis.",[580,26,335],"Peritonitis",[582,583],"Pentaglobin®","Personalized Medicine",{"date":532,"type":35},{"date":586,"type":35},"2017-11-20",{"date":588,"type":22},"2028-03",{"name":590,"class":42},"RWTH Aachen University",{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":601,"conditions":602,"keywords":603,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":613,"leadSponsor":615,"locationsCount":129},"100643390","sepsis-multiomic-analysis--risk-stratification-in-china-100643390","NCT07599644","Sepsis Multiomic Analysis & Risk sTratification in China","Sepsis Multiomic Analysis & Risk sTratification in China (China SMART-1): A Prospective Observational Cohort Study","China SMART-1","1. Inclusion Criteria for Sepsis Group Age \\> 18 years; Meet the Sepsis-3 diagnostic criteria for sepsis: confirmed or suspected infection with an increase in SOFA score (Sequential Organ Failure Assessment) of ≥ 2 points from baseline; Develop sepsis within 72 hours of ICU admission; Voluntarily sign the informed consent form (or signed by the legal representative).\n2. Inclusion Criteria for Non-Sepsis Group Age \\> 18 years; Hospitalized in the ICU of our hospital during the same period, with no clear evidence of infection and not meeting the diagnostic criteria for sepsis; Expected ICU treatment time ≥ 24 hours; Voluntarily sign the informed consent form (or signed by the legal representative).\n3. Exclusion Criteria Complicated with end-stage chronic organ failure (end-stage renal disease, decompensated liver cirrhosis (Child-Pugh Grade C), chronic heart failure NYHA Class IV), or malignant tumor; Immunocompromised or suffering from autoimmune diseases, or long-term use of glucocorticoids\u002Fimmunosuppressants within the past 3 months; Pregnant and postpartum patients; Patients with incomplete data collection; Other conditions deemed unsuitable for participation in the study by the investigator (such as terminal state, refusal to cooperate with sample collection, or inability to cooperate with in-hospital and out-of-hospital follow-up).",{"count":600,"type":22},1400,"Objectives:\n\n1. Perform Bulk RNA-seq transcriptome sequencing on enrolled samples to screen sepsis-specific mRNA diagnostic biomarkers and evaluate their diagnostic efficacy for early sepsis in the ICU; establish a molecular risk stratification system for sepsis based on mRNA expression profiles, and clarify the immunobiological characteristics, clinical manifestation differences, and prognostic risk levels of each stratification.\n2. Integrate core indicators screened from transcriptome sequencing, open-source databases, and previous studies to establish and optimize an RT-LAMP rapid detection method for core sepsis targets, validate its diagnostic accuracy, specificity, and reproducibility, and construct a rapid sepsis diagnostic model adapted to bedside scenarios.\n3. Integrate core indicators screened from open-source databases and previous studies to screen sepsis-specific diagnostic biomarkers in plasma and urine via PRM and metabolomics, complete protein\u002Fmetabolic level validation using immunological methods (ELISA), construct a combined diagnostic model for sepsis, and complete internal validation and efficacy evaluation.",[26],[26,604,605,606,607,608,609],"Early diagnosis","Biomarkers","RT-LAMP","ICU","Cohort study","Bulk RNA-seq","2026-06-08",{"date":532,"type":35},{"date":505,"type":35},{"date":614,"type":22},"2028-12-30",{"name":616,"class":42},"Yuebei People's Hospital",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":621,"acronym":622,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":18,"minAge":624,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":627,"conditions":628,"keywords":629,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":642},"100532924","evaluation-of-the-performance-of-the-idbioriv-method-in-pathogen-identification-and-antibiotic-susceptibility-testing-in-patients-with-sepsis-100532924","NCT06219135","Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis","IDBIORIV","Inclusion Criteria:\n\n* Adult or child patient\n* Hospitalized in one of the departments registered with Hospices Civils de Lyon\n* Showing signs of infection\n* Confirmed by a 1st positive blood culture\n* Patient or close relative (trustworthy person or family member) or holder of parental authority who has given his or her non-objection after receiving the information note\n\nExclusion Criteria:\n\n* Patients under court protection\n* Patients under guardianship or curatorship","1 Day",{"count":626,"type":22},1372,"Sepsis is a disruption of homeostasis in the human body in response to bloodstream infection and is associated with a high risk of mortality.\n\nWorldwide, sepsis is affecting approximately 30 million people and resulting in six million deaths.\n\nBlood culture is a specific blood sample used to identifying microbial agent (bacterium or yeast) and determine the sensitivity of these microorganisms to antibiotics and antifungals.\n\nAny delay in identifying the microorganism and\u002For determining the AST (antibiotic susceptibility testing) has a direct impact on the administration of appropriate antibiotic treatment and, consequently, on mortality of the patient. The faster the diagnosis, the faster the antibiotic treatment will be adapted, the higher the survival rate\u002Fprobability of patients, and the lower the ecological impact.\n\nIn routine, clinical microbiology laboratories currently use 2 automatized techniques: MALDI-TOF MS® for microorganisms identification and VITEK2® method for AST determination.\n\nBased on a proteomic approach, the IDBIORIV method is a rapid method (90 minutes) in comparison of current methods (24\u002F48 hours) able to identifying a large panel of 113 pathogens and determine the antibiotic resistance profile of 49 species for 4 classes of antibiotics (Beta-lactams, Aminosides, Glycopeptides, Colistin).\n\nThe main objective of this study is to evaluate the performance of the IDBIORIV method in pathogen identification and antibiotic susceptibility testing in comparison with current methods of analysis of positive blood cultures used at the microbiology laboratory of the Hospices Civils de Lyon, in a real clinical situation, over a 2-year period.",[26],[26,630,631,632,633,634,635],"bacteria","microbiology diagnosis method","identification","resistance","antibiotic susceptibility testing","virulence",{"date":464,"type":35},{"date":638,"type":35},"2024-03-21",{"date":640,"type":22},"2026-11-21",{"name":41,"class":42},23,{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":649,"eligibilityCriteria":650,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":140,"phases":653,"briefSummary":654,"conditions":655,"keywords":656,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":663,"leadSponsor":665,"locationsCount":425},"100611121","phase-1-labile-iron-removal-by-adding-the-iron-chelator-mex-cd1-to-dialysate-in-sepsis-associated-acute-kidney-injury-100611121","NCT07236463","Labile Iron Removal by Adding the Iron Chelator MEX-CD1 to Dialysate in Sepsis-Associated Acute Kidney Injury","Performance and Safety of Labile Iron Removal by Adding the Iron Chelator MEX-CD1 to Dialysate During Continuous Veno-venous Hemodialysis for Sepsis-associated AKI: Protocol for a Phase I-II Randomized Crossover Pilot Study.","IRON-IC","Inclusion Criteria:\n\n* Adult patients (≥18 years) admitted to ICU with sepsis-associated AKI requiring CRRT\n* Sepsis defined according to SEPSIS-3 criteria (suspected\u002Fdocumented infection with organ dysfunction indicated by ≥2-point increase in SOFA \\[Sequential Organ Failure Assessment\\] score)\n* AKI Stage 3 per KDIGO (Kidney Disease: Improving Global Outcomes) criteria: acute rise in serum creatinine ≥3 times baseline or serum creatinine ≥4 mg\u002FdL or urine output \\\u003C0.3 mL\u002Fkg\u002Fh for ≥24 hours or anuria (urine output \\\u003C100ml) for ≥12 hours\n* Indications for CRRT: refractory hyperkalemia (\\>6 mmol\u002FL) or refractory metabolic acidosis (pH \\\u003C 7.20) or acute pulmonary edema unresponsive to medical management or urine output \\\u003C0.3 ml\u002Fkg\u002Fhour or anuria (urine output \\\u003C100ml) persistent for 48 hours and refractory to medical treatment\n* Informed consent obtained from patient or legal representative\n* Affiliated with or beneficiary of a health insurance plan\n\nExclusion Criteria:\n\n* Known shellfish allergy\n* Moribund status with life expectancy too low to benefit\n* Concurrent participation in another interventional study\n* Exclusion period defined by another study\n* Under legal protection (guardianship or curatorship)\n* Inability to obtain informed consent from patient or representative\n* Pregnant, parturient, or breastfeeding women",{"count":652,"type":22},14,[280,309],"The goal of this clinical trial is to learn if adding the iron-binding drug MEX-CD1 to dialysis fluid can help remove excess iron in adults with sepsis-associated acute kidney injury (AKI) requiring dialysis who are in the intensive care unit (ICU). The main questions it aims to answer are:\n\nDoes adding MEX-CD1 to the dialysis fluid increase the amount of iron removed during dialysis? Is using MEX-CD1 in dialysis fluid safe for patients?\n\nParticipants will:\n\nBe adults in the ICU with sepsis-associated AKI who need continuous dialysis (renal replacement therapy) Receive two 24-hour dialysis sessions: one with standard dialysis fluid and one with dialysis fluid containing MEX-CD1 Serve as their own control, meaning they will receive both treatments\n\nResearchers will measure:\n\nThe amount of iron removed in the dialysis waste fluid (primary outcome) Blood levels of iron Changes in other trace elements Markers of inflammation and oxidative stress Safety outcomes up to 28 days after treatment This is a pilot study being done at a single hospital in France.",[312,26],[312,26,657,658,257],"Continuous Renal Replacement Therapy","Iron Chelating Agents","2026-06-04",{"date":661,"type":35},"2026-06-05",{"date":659,"type":35},{"date":664,"type":22},"2028-06",{"name":666,"class":42},"Centre Hospitalier Universitaire de Nīmes"]