[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"septic-shock\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:septic-shock":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,145,0,25,[9,40,60,93,120,142,178,197,225,247,276,302,328,349,370,398,430,455,482,504,531,549,581,600,625],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100053440","septic-shock-induced-immunosuppression-100053440",false,"NCT04067674","Septic Shock-induced Immunosuppression","Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration","IMMUNOSEPSIS 4","Inclusion Criteria:\n\n* Age over 18 years\n* Patient admitted to ICU\n* Diagnosis of septic shock within less than 48h at time of screening defined by :\n* Presence of a microbiologically diagnosed or suspected infection\n* Initiation of a vasopressive treatment to maintain mean arterial blood pressure ≥ 65 mm Hg initiated during the first 48h after ICU admission\n* Presence of an hyperlactatemia \\> 2 mmol\u002FL (18 mg\u002FdL) during the 24h before or after initiation of vasopressive treatment despite adequate volemic reanimation (30 ml\u002Fkg)\n* Blood sample at D3\u002FD4 available (lab working days)\n* Non opposition to study participation obtained from patient or next of kin\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Patient with no social security insurance, with restricted liberty or under legal protection\n* Language barrier\n* Patient taking part in interventional study about medicin that could interfere with biologic results","ALL","18 Years",{"count":21,"type":22},305,"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. The prerequisite for immunostimulation administration (Interferon gama (IFNg), Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interleukin 7 (IL-7)) however relies on clinicians' capacity to identify patients who could benefit the most from these immunoadjuvant therapies, as there is no clinical sign of immune dysfunctions.\n\nIn this context, the main objectives of IMMUNOSEPSIS 4 study are:\n\n1. to identify the best biomarkers for sepsis-induced immunosuppression\n2. to evaluate ex vivo candidate treatments which could rejuvenate immune functions after septic shock",[26],"Septic Shock","RECRUITING","2026-07-10",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":31},"2019-10-21",{"date":35,"type":22},"2026-11-21",{"name":37,"class":38},"Hospices Civils de Lyon","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":4},"100053780","splanchnic-perfusion-monitoring-in-septic-shock-using-doppler-ultrasound-100053780","NCT07698834","Splanchnic Perfusion Monitoring in Septic Shock Using Doppler Ultrasound","Splanchnic Perfusion Monitoring Using Doppler Ultrasound in Septic Shock Patients: Correlation With Lactate Clearance, Organ Dysfunction, and Enteral Feeding Intolerance","Inclusion Criteria:\n\n* 1\\. Adult patients (≥18 years). 2. ICU admission with septic shock (Sepsis-3 definitions).\n\nExclusion Criteria:\n\n\\- 1. Advanced chronic liver disease. 2. Portal vein thrombosis. 3. Mesenteric ischemia (or clinical suspicion strongly suggesting it). 4. Severe right-sided heart failure. 5. Pregnancy. 6. Morbid obesity or any condition causing poor\u002Funsafe ultrasound acoustic window.\n\n7\\. Intra-abdominal conditions preventing adequate Doppler assessment. 8. Limitation of care \u002F do-not-resuscitate orders. 9. Pre-existing major gastrointestinal bleeding\u002Fobstruction if that is relevant to enteral feeding intolerance outcomes in your ICU.",{"count":48,"type":22},80,"evaluation whether splanchnic Doppler ultrasound indices (SMA resistive index, portal vein pulsatility fraction, hepatic artery resistive index\u002Fflow parameters) can:\n\n1. Reflect regional tissue perfusion in septic shock, as correlated with lactate clearance.\n2. Associate with organ dysfunction severity and progression (SOFA dynamics).\n3. Predict enteral feeding intolerance in ICU patients receiving enteral nutrition",[26],"NOT_YET_RECRUITING","2026-07-07",{"date":30,"type":31},{"date":55,"type":22},"2026-09",{"date":57,"type":22},"2027-10",{"name":59,"class":38},"Assiut University",{"id":61,"slug":62,"hasResults":12,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":76,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100641441","hemoadsorpion-in-patients-with-septic-shock-efficacy-and-safety-evaluation-100641441","NCT07661303","Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation","Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial","HAdSS","Inclusion Criteria:\n\n* Septic shock according to SEPSIS-3 criteria\n* Age: 18-80 years\n* SOFA ≥9 points\n* Diagnosis of septic shock established \\\u003C12 hours ago\n* Invasive hemodynamic monitoring\n* Norepinephrine dose \\>0.2 mcg\u002Fkg\u002Fmin\n\nExclusion Criteria:\n\n* Absolute neutrophil count less than 500 cells\u002FμL\n* Pregnancy\n* End-stage heart failure (NYHA stage IV)\n* Pulmonary embolism with obstructive shock\n* Ongoing bleeding\n* Atonic coma\n* More than 30 points on the MELD scale, class C on the Child-Pugh scale\n* HIV infection\n* Burns over 10% of the body surface area\n* Patients with oncohematological diseases\n* Patients with a recognized palliative status or the definition of \"metastatic cancer\"\n* RRT using membranes with a high cutoff point and increased adsorption capacity within 72 hours from the initiation of the first hemoadsorption procedure\n* Use of plasma exchange within 72 hours from the initiation of the first hemoadsorption procedure","80 Years",{"count":70,"type":22},76,"INTERVENTIONAL",[73],"NA","Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial.\n\nThe goal of this clinical trial is the estimation of the efficacy and safety of hemoadsorption procedures (LPS (Lipopolysaccharide) and inflammatory mediators adsorption) in participants with septic shock.\n\nThe main questions it aims to answer are:\n\nDoes hemoadsorption decrease the severity of MODS (multiple organ disfunction syndrome)?\n\nThe study will include participants aged 18 to 80 years with a verified diagnosis of septic shock according to SEPSIS 3 criteria, diagnosed within 12 hours, and a SOFA (sequential organ failure assessment) score of 9 or more.\n\nIn addition to Standard of Care (SOC), blood purification, including hemoadsorption, will be used. The minimum waiting time after diagnosis of septic shock and initiation of basic therapy before inclusion of the patient in the study therapy is 4 hours.\n\nThe choice of procedure will be based on the EAA (Endotoxin Activity Assay) result:\n\n* for an EAA level of 0.6-0.9, selective lipopolysaccharide (LPS) adsorption with duration from 2 to 10 hours;\n* for an EAA level less than 0.6, inflammatory mediator adsorption with duration from 6 to 12 hours.\n\nThe choice of a specific adsorbers within the LPS and inflammatory mediator adsorption group will be based on randomization.\n\nThe use of LPS adsorption is planned based on randomization: Toramyxin R-20 or Efferon LPS. The use of inflammatory mediator adsorption is planned based on randomization: Jafron (HA 330) or CytoSorb.",[26],[77,78,79,80,81],"Septic shock","hemoadsorption","blood purification","MODS","Endotoxemia","2026-06-30",{"date":84,"type":31},"2026-07-02",{"date":86,"type":22},"2026-06-25",{"date":88,"type":22},"2027-12-25",{"name":90,"class":91},"Moscow Multidisciplinary Clinical Center \"Kommunarka\"","OTHER_GOV",7,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":18,"minAge":19,"maxAge":68,"enrollmentInfo":101,"targetDuration":103,"studyType":23,"phases":4,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"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.",true,{"count":102,"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.",[106,26],"Sepsis",[106,108,109,110],"Bone marrow","Myeloid bias","Prognosis","2026-06-18",{"date":113,"type":31},"2026-06-24",{"date":115,"type":22},"2026-07-15",{"date":117,"type":22},"2027-12-30",{"name":119,"class":38},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":39},"100327767","does-urinary-timp2-and-igfbp7-can-identify-high-risk-patients-of-progression-from-mild-and-moderate-to-severe-acute-kidney-injury-during-septic-shock-100327767","NCT03547414","Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Moderate to Severe Acute Kidney Injury During Septic Shock?","Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Moderate to Severe Acute Kidney Injury During Septic Shock? HEMOCHECK","HEMOCHECK","Inclusion Criteria:\n\n* Age 18 or over\n* Septic shock (according to Bone's criteria) within 4 hours of introduction of catecholamines\n* AKI, characterized by a KDIGO score ≥ 1\n* Social security coverage\n\nExclusion Criteria:\n\n* AKI requiring emergency RRT (in the critical care physician's opinion).\n* Anuria\n* Stage 4-5 chronic kidney failure with a GFR below 30 ml\u002Fmin.\n* Rapidly progressing renal disorders (glomerulonephritis, HUS, blockage, etc.)\n* Obstructive AKI\n* Probable glomerular damage (nephritic syndrome, nephrotic syndrome, chronic glomerulonephritis)\n* Pregnancy or breastfeeding\n* Legal guardianship or lack of social security coverage.\n* Cardiocirculatory arrest\n* Life expectancy \\\u003C48 hours.\n* Child C cirrhosis\n* Prior occurrence of AKI during the current hospital stay\n* Transplantation\n* Subject participating in another study with an exclusion period ongoing at the time of the pre-inclusion",{"count":129,"type":22},110,"Septic shock is one of the leading causes of death in patients admitted to the intensive care unit (ICU). Acute kidney injury (AKI) occurs in almost 50% of septic patients and is associated with significant mortality. Progression to the last stage (KDIGO stage 3) of AKI is an important step in the disease, as it usually requires initiation of RRT. Renal biomarkers are unable to accurately identify those patients who will progress to severe AKI (KDIGO 3). However, identification of patients at risk of progression to severe AKI could help the clinician to initiate optimal therapy including RRT. A new urine test, the Nephrocheck™ corresponding to the product of the urinary concentrations of 2 markers of renal tubule injury (TIMP2 and IGFBP7) has been validated. The Investigator have already performed two previous studies including septic shock patients (AKICHECK and BIOOCHECK). those previous datas will be reanalysed to examine whether the new urinary biomarkers TIMP2 and IGFBP7 can predict progression within 24 hours and 72 hours from mild and moderate (KDIGO 1 or 2) to severe AKI (KDIGO 3) in patients with septic shock.\n\n-All the datas required will be collected from two previous studies (AKICHECK and BIOCHECK) performed in 3 centers: Amiens medical ICU, Melun medico surgical ICU and Montpellier Medical ICU.",[132,26],"Acute Kidney Injury","2026-06-15",{"date":135,"type":31},"2026-06-16",{"date":137,"type":31},"2018-05-16",{"date":139,"type":22},"2026-06",{"name":141,"class":38},"Centre Hospitalier Universitaire, Amiens",{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":71,"phases":153,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":176,"locationsCount":39},"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.","85 Years",{"count":152,"type":22},20,[73],"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.",[26,106,156],"Critical Illness",[158,159,160,161,162,163,164,165,166,167,168,169,170],"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":111,"type":31},{"date":174,"type":22},"2026-08-01",{"date":117,"type":22},{"name":177,"class":38},"First Affiliated Hospital of Wannan Medical College",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":150,"enrollmentInfo":185,"targetDuration":4,"studyType":71,"phases":186,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":194,"leadSponsor":195,"locationsCount":196},"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":152,"type":22},[73],"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.",[26,106,189],"Critical Illness Sepsis, Severe",[191,161,162,164,165,163,26],"esmolol",{"date":111,"type":31},{"date":174,"type":22},{"date":117,"type":22},{"name":177,"class":38},2,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":150,"enrollmentInfo":204,"targetDuration":4,"studyType":71,"phases":205,"briefSummary":206,"conditions":207,"keywords":211,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":223,"leadSponsor":224,"locationsCount":196},"100641345","papaverine-and-sublingual-microcirculation-in-septic-shock-100641345","NCT07657741","Papaverine and Sublingual Microcirculation in Septic Shock","Effects of Papaverine 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\n* Age 18-85 years.\n* Septic shock according to Sepsis-3 criteria, defined as suspected or documented infection requiring vasopressors 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 continuous norepinephrine infusion at enrollment.\n* Receiving invasive mechanical ventilation at enrollment, allowing assessment of vascular waterfall-related hemodynamic variables.\n* PiCCO-based hemodynamic monitoring, invasive arterial pressure monitoring, and central venous access available before papaverine administration.\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 primarily caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.\n* Expected death or planned withdrawal of life-sustaining treatment within 24 hours.\n* Known allergy or hypersensitivity to papaverine.\n* Severe hemodynamic instability judged unsuitable for papaverine by the treating physician, including refractory hypotension or rapidly escalating vasopressor requirement.\n* Clinically significant arrhythmia, high-grade atrioventricular block, acute coronary syndrome, or active myocardial ischemia before enrollment.\n* Severe hepatic dysfunction judged by the investigator to substantially increase the risk of papaverine-related adverse effects.\n* Conditions preventing reliable 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":152,"type":22},[73],"This is a prospective, multicenter, single-arm, open-label, pilot physiological study designed to evaluate the effects of intravenous papaverine on sublingual microcirculation and the vascular waterfall phenomenon 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, and have PiCCO-based hemodynamic monitoring available before papaverine administration. Papaverine will be administered as an intravenous infusion of 30 mg over 10 minutes, followed by a continuous infusion of 2-5 mg\u002Fhour. Sublingual microcirculatory variables, vascular-waterfall-related indices, PiCCO-derived hemodynamic variables, macrocirculatory parameters, tissue perfusion variables, vasopressor dose, and safety outcomes will be assessed before and after papaverine administration.\n\nThe study aims to explore whether papaverine can improve microvascular perfusion and reduce microcirculatory flow impairment in septic shock, and to provide preliminary physiological and safety data for future controlled trials.",[26,208,209,210],"Microcirculatory Dysfunction","Sublingual Microcirculation","Hemodynamic Instability",[77,212,213,214,215,216,217,218,219,220],"Papaverine","Sublingual microcirculation","Microcirculatory dysfunction","Vascular waterfall phenomenon","Critical closing pressure","Perfused vessel density","Microvascular flow index","Proportion of perfused vessels","Pilot physiological study",{"date":111,"type":31},{"date":174,"type":22},{"date":117,"type":22},{"name":177,"class":38},{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":150,"enrollmentInfo":233,"targetDuration":4,"studyType":71,"phases":234,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":245,"leadSponsor":246,"locationsCount":196},"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":152,"type":22},[73],"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.",[26,106,156],[238,160,161,162,163,164,165,166,167,168,169,239,240,241,242],"dexmedetomidine","sedation","bradycardia","hypotension","norepinephrine",{"date":111,"type":31},{"date":174,"type":22},{"date":117,"type":22},{"name":177,"class":38},{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":71,"phases":257,"briefSummary":258,"conditions":259,"keywords":261,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":275},"100606724","veno-arterial-carbon-dioxide-partial-pressure-difference-co2gap-for-early-resuscitation-of-septic-shock-100606724","NCT07179276","Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock","Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock: A Multicenter Prospective Randomized Trial (CARBON)","CARBON","Inclusion Criteria:\n\n* Patients aged 18 years or older AND\n* Acutely admitted to a study ICU AND\n* Primary diagnosis of septic shock according to the Sepsis-3 criteria and defined as:\n\n  * A suspected or documented site of infection or positive blood culture AND\n  * Acute increase of at least 2 points in the Sequential Organ Failure Assessment (SOFA) score consequent to the infection AND\n  * Having a serum lactate level \\>2 mmol\u002Fl AND\n  * Requirement of vasopressors (any dose of norepinephrine) to maintain mean arterial pressure (MAP) ≥65 mmHg despite adequate fluid resuscitation (at least 1L of IV fluid in the last 24 hours prior to screening)\n\nExclusion Criteria:\n\n* Septic shock for more than 12 hours at the time of screening\n* Primary cause of hypotension not due to sepsis (e.g., acute bleeding)\n* Decision not to resuscitate (or to limit full care) or not to intubate taken before obtaining consent\n* Death is deemed to be imminent or inevitable or patients with an underlying disease process with a life expectancy of less than 3 months\n* Anticipated surgery during the first 24 hours after randomization\n* Patient or their relatives' refusal to participate\n* Patients participating in another RCT with interventions possibly compromising the primary outcome\n* Prior enrollment in the CARBON trial\n* Known to be pregnant.\n* Legal protection (i.e., incompetence to provide consent and no guardian or incarceration)\n* No affiliation with the French health care system",{"count":256,"type":22},750,[73],"Sepsis is a dysregulated host response to infection that leads to life-threatening organ dysfunction and represents a major healthcare problem. Septic shock is the most severe form, characterized by increased capillary permeability and vasodilation, resulting in hypotension and tissue hypoxia. Early identification and treatment of tissue hypoperfusion are pivotal components of initial resuscitation to limit progression to multiple organ dysfunction and death. The 2021 Surviving Sepsis Guidelines recommend guiding initial resuscitation by targeting decreases in serum lactate levels in patients with elevated lactate. However, although elevated lactate levels may reflect tissue hypoxia, serum lactate is not a direct marker of tissue perfusion. Hyperlactatemia may be attributable to mechanisms other than tissue hypoperfusion, such as accelerated aerobic glycolysis driven by excessive β-adrenergic stimulation or impaired clearance (e.g., in liver failure).\n\nThe venous-to-arterial carbon dioxide partial pressure difference (CO₂ gap), which is inversely related to cardiac output, has been shown to reflect the adequacy of venous blood flow to remove CO₂ from tissues. The CO₂ gap is closely linked to microcirculatory blood flow during the early resuscitation phase of septic shock and may effectively identify persistent tissue hypoperfusion in shock states. A persistently high CO₂ gap during early resuscitation has been associated with significantly higher 28-day mortality and increased Sequential Organ Failure Assessment (SOFA) scores. Moreover, the CO₂ gap has been shown to respond to changes in cardiac output during inotrope infusion in patients with low blood flow, suggesting that its assessment could be useful for therapeutic adjustments. Therefore, there are compelling arguments to evaluate the usefulness of the CO₂ gap in guiding early resuscitation in patients with septic shock.\n\nThe investigators postulated that CO₂ gap-guided early resuscitation may be more effective in improving outcomes than lactate-guided resuscitation.",[260,26],"Sepsis - to Reduce Mortality in the Intensive Care Unit",[262,263,264,265,266],"lactate","CO2 gap","resuscitation strategie","sepsis","hemodynamic therapy","2026-06-12",{"date":133,"type":31},{"date":270,"type":31},"2026-03-29",{"date":272,"type":22},"2027-12-31",{"name":274,"class":38},"University Hospital, Clermont-Ferrand",28,{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":71,"phases":285,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":152},"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":284,"type":22},200,[286],"PHASE2","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.",[289,106,26],"Peritonitis",[291,292],"Pentaglobin®","Personalized Medicine","2026-06-10",{"date":295,"type":31},"2026-06-11",{"date":297,"type":31},"2017-11-20",{"date":299,"type":22},"2028-03",{"name":301,"class":38},"RWTH Aachen University",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":71,"phases":312,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":196},"100573474","phase-4-mechanistic-assessment-of-norepinephrine-therapy-vs-angiotensin-ii-in-septic-shock-100573474","NCT06746753","Mechanistic Assessment of Norepinephrine Therapy vs. Angiotensin-II in Septic Shock","Mechanistic Assessment of Norepinephrine TheRapy vs. Angiotensin-II in Septic Shock (MANTRA) Grant Submission- Dysfunctional Renin-Angiotensin System in Septic Shock","MANTRA","Inclusion Criteria:\n\n\\- The presence of septic shock, defined by sepsis-3 criteria: 1-adult patients (18 years or older) with septic shock, defined by SEPSIS-3 criteria: a) suspected or known infection, b) hypotension requiring vasopressors, and c) lactate \\>2mmol\u002FL 2-receiving either norepinephrine or phenylephrine with or without additional vasopressor support 3- total norepinephrine equivalent dose (NED) ≥0.1 mcg\u002Fkg\u002Fmin and ≤0.5 mcg\u002Fkg\u002Fmin, to maintain a MAP of at least 65 mmHg, is required for randomization 4-ability to consent and randomize within 24 hrs of first reaching NED threshold and within 48 hrs of hospital arrival\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Prisoners\n* Pregnant women\n* Patients for whom urgent surgery is anticipated\n* Leukocyte count \\\u003C1,000 cells\u002FμL\n* Absolute monocyte count \\\u003C200 cells\u002FμL\n* Bone marrow transplant within the past 30 days\n* Patients that will be withdrawing aggressive resuscitation, including withdraw of vasopressor support\n* transfer from outside ICU\n* history of liver cirrhosis with Child-Pugh score ≥6",{"count":311,"type":22},78,[313],"PHASE4","Despite best therapy efforts, sepsis and septic shock are associated with mortality rates of up to 40%. This clinical trial will determine the benefit of exogenous Angiotensin II versus norepinephrine (conventional care) treatment in septic shock patients. This trial will determine whether there are better predictors of septic shock severity. This approach may inform more appropriate treatment regimens and improve outcomes for these patients.",[26],[265,317,318],"kidney disease","intensive care","2026-06-02",{"date":321,"type":31},"2026-06-04",{"date":323,"type":22},"2026-07",{"date":325,"type":22},"2028-10-07",{"name":327,"class":38},"Wake Forest University Health Sciences",{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":338,"conditions":339,"keywords":340,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":345,"leadSponsor":347,"locationsCount":196},"100638041","comparison-of-cardiac-index-measurement-using-right-ventricular-pressure-curve-analysis-and-thermodilution-via-a-swan-ganz-iq-catheter-100638041","NCT07628023","Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.","Comparison of Cardiac Index Measurement by Analysis of the Right Ventricular Pressure Curve and by Thermodilution During Pulmonary Artery Catheterization Using Swan Ganz IQ™.","MICAP","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Hospitalization in intensive care\n* Presence of a Swan-Ganz IQ™ pulmonary artery catheter placed as part of treatment\n* Thermodilution performed by the clinician in charge as part of treatment\n\nExclusion Criteria:\n\n* Pregnancy\n* Legal protective measures (guardianship, conservatorship, and deprivation of liberty by court\u002Fadministrative decision)\n* Refusal of participation by the patient's relatives or the patient themselves.\n* Cardiac output measurements by thermodilution or continuous cardiac output analysis that cannot be used.",{"count":337,"type":22},43,"The pulmonary artery catheter (Swan-Ganz) is a standard tool in intensive care for measuring and monitoring cardiac index by thermodilution. The Swan-Ganz IQ™ model also allows continuous estimation of cardiac index through analysis of the right ventricular pressure wave, which could be useful for rapidly assessing changes in cardiac output during volume expansion response tests. However, the concordance between this continuous method and thermodilution remains poorly studied in real clinical conditions and may vary depending on certain clinical situations. This study therefore aims to compare the cardiac index measured by thermodilution with that estimated by right ventricular pressure waveform analysis based on data collected in clinical practice.",[26],[341],"Swan-Ganz IQ™, Swan-Ganz, thermodilution, cardiac index.","2026-06-01",{"date":321,"type":31},{"date":293,"type":22},{"date":346,"type":22},"2028-06-10",{"name":348,"class":38},"Assistance Publique - Hôpitaux de Paris",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":366,"leadSponsor":368,"locationsCount":39},"100637629","early-diagnosis-of-septic-dic-100637629","NCT07630415","EARLY DIAGNOSIS OF SEPTIC DIC","OPTIMIZATION AND CLINICAL VALIDATION OF AN INNOVATIVE TEST FOR THE EARLY DIAGNOSIS OF SEPTIC DIC VIA AN AUTOMATION INTEGRATING ARTIFICIAL INTELLIGENCE","EASY-DIC","Inclusion Criteria:\n\n* Male or female ≥ 18 years old\n* Patient admitted to intensive care for septic shock\n* Patient affiliated with a social security scheme or having rights\n* No objection from the patient or a relative in case the patient is not able to express consent, or inclusion under emergency procedure in case the patient is not able to express their opinion and no relative of the patient is reachable.\n\nExclusion Criteria:\n\n* Moribund patient on the day of inclusion\n* Child-Pugh C cirrhosis\n* Neutropenia (\\\u003C500 mm3)\n* Patient under legal protection\n* Patient under guardianship or curatorship\n* Pregnancy\u002F Breastfeeding",{"count":358,"type":22},492,"Disseminated Intravascular Coagulation is a severe complication of septic shock, associated with high mortality, whose diagnosis relies on complex scores that are rarely used in practice. Preliminary studies have shown that increased neutrophil fluorescence is associated with Disseminated Intravascular Coagulation and could reflect NETosis, a key mechanism of immunothrombosis. This study aims to validate neutrophil fluorescence measured on the SthemA 801 analyzer, alone or integrated into an artificial intelligence model, as an early, reliable, and routinely usable biomarker for the diagnosis of septic Disseminated Intravascular Coagulation.",[361,362,26],"Disseminated Intravascular Coagulation (DIC)","Reanimation",{"date":364,"type":31},"2026-06-05",{"date":133,"type":22},{"date":367,"type":22},"2029-01-15",{"name":369,"class":38},"University Hospital, Strasbourg, France",{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":71,"phases":380,"briefSummary":381,"conditions":382,"keywords":385,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":397},"100627688","phase-2-adjunctive-fludrocortisone-in-septic-shock-100627688","NCT07451886","Adjunctive Fludrocortisone in Septic Shock","Adjunctive Fludrocortisone in Septic Shock: a Multicenter, Double-blind, Randomized, Placebo-controlled Pilot Trial (AFLUDROS-1)","AFLUDROS-1","Inclusion Criteria:\n\n1. suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection\n2. ≥0.25 μg\u002Fkg\u002Fmin of noradrenaline infusion or vasoactive-inotropic score (VIS) ≥25 to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour\n3. onset of septic shock within 24 hours\n4. shock due to infection with no other proven or apparent cause\n5. hypoperfusion defined as arterial or venous lactate concentration \\>2.0 mmol\u002FL\n6. mechanical ventilation\n\nExclusion Criteria:\n\n1. fludrocortisone cannot be administered within 24 hours of onset of septic shock\n2. death is deemed imminent or inevitable by treating clinicians\n3. limitation of therapy\n4. an underlying disease process with a life expectancy of less than 90 days\n5. pregnancy (confirmed or suspected)\n6. receiving immunomodulatory agents including hydrocortisone \\> 300mg\u002Fday\n7. enteral medication cannot be administered\n8. prescribed fludrocortisone for other medical condition\n9. contraindication to hydrocortisone or fludrocortisone",{"count":379,"type":22},32,[286],"Sepsis is a life-threatening condition caused by the body's dysregulated response to an infection. While corticosteroids are known to help stabilize blood pressure in septic shock, their ability to reduce mortality is still debated. Recent analyses suggest that combining fludrocortisone with hydrocortisone may be more effective at saving lives than hydrocortisone alone.\n\nTo test this hypothesis, a large, definitive international trial is needed. However, this research proposal is for a smaller pilot study (Phase II) involving 32 critically ill patients. The primary goal of this pilot is to determine the feasibility of conducting the subsequent large-scale trial that would compare hydrocortisone alone against the combination therapy and potentially change medical practice.",[106,26,260,383,384],"Sepsis and Septic Shock","Sepsis at Intensive Care Unit",[386,77,106,387,388,389],"Fludrocortisone","hydrocortisone","intensive care unit","pilot",{"date":319,"type":31},{"date":392,"type":31},"2026-04-01",{"date":394,"type":22},"2028-07-31",{"name":396,"class":38},"Chinese University of Hong Kong",5,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":18,"minAge":404,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":71,"phases":407,"briefSummary":409,"conditions":410,"keywords":413,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":196},"100633704","phase-3-comparative-efficacy-and-safety-of-propofol-ketamine-combination-versus-propofol-monotherapy-in-geriatric-patients-under-invasive-ventilation-100633704","NCT07530146","Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation","Inclusion Criteria:\n\n* Age ≥ 65 years\n* Admitted to ICU with a diagnosis of infection (sepsis, septic shock, or pneumonia)\n* Known history of cardiac disease (e.g., ischemic heart disease, heart failure, arrhythmias)\n* Requiring endotracheal intubation for airway protection or respiratory failure\n* Informed consent obtained from patient or legal representative\n* Patient NOT on sedation prior randomization.\n\nExclusion Criteria:\n\n* Known allergy or contraindication to propofol or ketamine\n* Severe hepatic or renal dysfunction (Child-Pugh C, eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²)\n* Uncontrolled hypertension (SBP \\> 180 mmHg or DBP \\> 110 mmHg)\n* Intracranial pathology (e.g., raised intracranial pressure, recent stroke, brain tumor)\n* Ongoing use of other sedative or anesthetic agents within 12 hours prior to intubation\n* Do-not-intubate or do-not-resuscitate orders\n* Participation in another interventional trial within the last 30 days\n* History of Psychosis\n* Severe Organ Dysfunction: Patients with Child-Pugh C hepatic failure\n* • Severe hypotension despite vasopressor therapy (systolic blood pressure \\\u003C 100 mmHg or diastolic blood pressure \\\u003C 70 mmHg)","65 Years",{"count":406,"type":22},41,[408],"PHASE3","The study is a prospective randomized controlled trial comparing the efficacy and safety of propofol-ketamine (\"Ketofol\") versus propofol monotherapy in geriatric ICU patients. Eligible participants are critically ill elderly patients with a history of cardiac disease who require endotracheal intubation and have not yet received sedation. The investigators focus on a specific population in which geriatric patients have different pharmacokinetics and pharmacodynamics and are more prone to side effects than other populations.\n\nPrimary outcome: Incidence of hemodynamic instability (defined as hypotension requiring vasopressors), measured by mean arterial pressure (MAP) at baseline, during intubation, and post-intubation at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours.",[411,26,412],"The Critically Ill Patient is Requiring Intubation","Pneumonia",[414,415,160,416,417,418,419,420,421],"ketofol","propofol","pneumonia","geriatric","elderly","critical ill","ICU patient","intubation","2026-05-28",{"date":342,"type":31},{"date":425,"type":22},"2026-04",{"date":427,"type":22},"2026-10",{"name":429,"class":38},"Helwan University",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":71,"phases":438,"briefSummary":439,"conditions":440,"keywords":441,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":39},"100638043","effect-of-shenfu-injection-on-the-vascular-waterfall-phenomenon-in-patients-with-septic-shock-100638043","NCT07603024","Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock","Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective Pilot Study","nclusion Criteria Septic shock diagnosed according to Sepsis-3 criteria after adequate fluid resuscitation.\n\nAge ≥ 18 years. Within 24 hours of ICU admission. Receiving norepinephrine ≥ 0.10 µg\u002Fkg\u002Fmin to maintain mean arterial pressure ≥ 65 mmHg.\n\nHemodynamically stable without vasopressor dose adjustment for ≥ 30 minutes before baseline measurement.\n\nEndotracheal intubation with controlled mechanical ventilation under continuous sedation and analgesia.\n\nPresence of both arterial and central venous catheters with PiCCO monitoring capability.\n\nWritten informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria Cardiogenic shock as primary diagnosis or cardiac index \\\u003C 2.2 L\u002Fmin\u002Fm² after optimization.\n\nSevere pulmonary bullae, pneumothorax, or conditions precluding safe inspiratory hold maneuvers.\n\nPregnancy or lactation. Expected ICU stay \\\u003C 48 hours or limitation of life-sustaining therapy. Known allergy or contraindication to Shenfu Injection or its ingredients (e.g., ginseng, aconitum).",{"count":152,"type":22},[73],"This prospective single-center clinical trial aims to evaluate the circulatory and microcirculatory effects of Shenfu Injection in patients with septic shock. The study focuses on the vascular waterfall phenomenon, which describes the relationship between arterial and venous pressures in the microcirculation.\n\nEligible participants with septic shock will receive an intravenous infusion of 100 mL Shenfu Injection (manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd.). Hemodynamic and oxygen metabolism parameters will be measured before and 3 hours after treatment. The main goal is to determine whether Shenfu Injection influences the vascular waterfall difference, expressed as the gap between critical closure pressure and mean systemic filling pressure.\n\nThis study will also record changes in cardiac index, systemic vascular resistance, blood lactate, venous oxygen saturation, and norepinephrine requirement. Findings will provide preliminary clinical evidence about the role of Shenfu Injection in circulatory regulation during septic shock and help design future randomized controlled studies.",[26],[442,443,26,444,445,446],"Shenfu Injection","Traditional Chinese Medicine","Vascular Waterfall Phenomenon","Critical Closure Pressure","Intensive Care Unit","2026-05-18",{"date":449,"type":31},"2026-05-22",{"date":451,"type":22},"2026-07-01",{"date":453,"type":22},"2027-06-30",{"name":177,"class":38},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":71,"phases":464,"briefSummary":465,"conditions":466,"keywords":471,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":39},"100592197","focused-ultrasound-spleen-stimulation-and-inflammation-in-septic-shock-100592197","NCT06990295","Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock","Effects of Focused Ultrasound Spleen Neuromodulation on Inflammatory Cytokine Levels in Patients With Septic Shock: A Randomized Controlled Pilot Trial","Inclusion Criteria:\n\n* Age ≥ 18 years, regardless of sex\n* Diagnosed with septic shock according to Sepsis-3 criteria: Sequential Organ Failure Assessment (SOFA) score ≥ 2 and requiring vasopressor support to maintain a mean arterial pressure (MAP) ≥ 65 mmHg.\n* Admitted to the ICU within 24 hours of septic shock diagnosis\n* Expected to require intensive care for at least 72 hours\n* Informed consent obtained from the patient or legal representative\n\nExclusion Criteria:\n\n* Known pregnancy or breastfeeding\n* Participation in another interventional clinical trial within 30 days\n* Known immunodeficiency or ongoing immunosuppressive therapy\n* Malignancy with life expectancy \\\u003C 6 months\n* Contraindications to focused ultrasound (e.g., splenic trauma, splenectomy, local skin infection)\n* Do-not-resuscitate (DNR) order or expected death within 24 hours\n* Any other condition deemed unsuitable for participation by the investigators",{"count":463,"type":22},40,[73],"This study evaluates the safety and effectiveness of focused ultrasound spleen neuromodulation in patients with septic shock, a life-threatening condition characterized by excessive inflammation and organ dysfunction. The primary objective is to determine whether non-invasive, focused ultrasound stimulation of the spleen can reduce circulating inflammatory cytokine levels in this patient population.\n\nEligibility Criteria:\n\nAdults aged 18 years or older Diagnosed with septic shock and admitted to the ICU within 24 hours Expected to require intensive care for at least 72 hours\n\nStudy Protocol:\n\nParticipants will be randomly assigned to one of two groups:\n\nIntervention Group: Will receive standard septic shock care plus twice-daily focused ultrasound stimulation over the spleen for five days, using a portable device.\n\nControl Group: Will receive standard septic shock care alone. Blood samples will be collected at baseline and Day 5 to measure inflammatory cytokine levels, including TNF-α, IL-1β, IL-6, and IL-10. Additional assessments will include lymphocyte subpopulations, organ function scores, ICU length of stay, 28-day mortality, and adverse events.\n\nOutcome Measures:\n\nPrimary: Change in levels of inflammatory cytokines on Day 5. Secondary: Changes in organ function (SOFA score), ICU length of stay, 28-day survival, and safety\u002Ftolerability of the intervention.",[26,467,468,469,470],"Inflammatory Cytokines","Spleen Neuromodulation","Focused Ultrasound","Critical Care",[26,469,468,467,470,472,473],"Immune Modulation","Pilot Study","2026-05-15",{"date":476,"type":31},"2026-05-19",{"date":478,"type":31},"2025-07-25",{"date":480,"type":22},"2026-12-31",{"name":177,"class":38},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":491,"conditions":492,"keywords":493,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":39},"100638126","cortisol-levels-and-mortality-in-septic-shock-icu-patients-100638126","NCT07582926","Cortisol Levels and Mortality in Septic Shock ICU Patients","Prognostic Value of Cortisol Levels in Critically Ill Patients With Sepsis and Septic Shock: A Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Age 18 years or older\n* Admission to the intensive care unit for more than 24 hours\n* Presence of a clinically or microbiologically confirmed source of infection\n* Diagnosis of sepsis or septic shock during ICU stay\n\nExclusion Criteria:\n\n* Pregnancy\n* Known disorders of the hypothalamic-pituitary-adrenal (HPA) axis\n* Known disorders affecting cortisol secretion 4.Long-term systemic glucocorticoid use (≥3 months)",{"count":490,"type":22},183,"This prospective observational study aims to evaluate the prognostic value of cortisol levels and their dynamic changes in critically ill patients with sepsis and septic shock admitted to the intensive care unit. Cortisol plays a crucial role in maintaining hemodynamic stability and modulating the inflammatory response during critical illness, and relative adrenal insufficiency has been associated with worse clinical outcomes.\n\nAdult patients admitted to the intensive care unit with sepsis or septic shock will be enrolled and followed prospectively. Serum cortisol levels will be measured, and their association with clinical outcomes, including intensive care unit mortality, 28-day mortality, and 90-day mortality, will be analyzed. In addition, the relationship between cortisol levels and disease severity scores such as SOFA and APACHE, as well as laboratory parameters including inflammatory biomarkers, will be evaluated.\n\nThe findings of this study are expected to contribute to the early identification of high-risk patients and improve prognostic assessment in critically ill patients with sepsis and septic shock.",[106,26],[265,160,494,495,388],"cortisol","mortality","2026-05-14",{"date":447,"type":31},{"date":499,"type":22},"2026-05-01",{"date":501,"type":22},"2026-12-01",{"name":503,"class":91},"Ankara Etlik City Hospital",{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":514,"conditions":515,"keywords":518,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":527,"leadSponsor":529,"locationsCount":39},"100630773","validation-of-the-use-of-the-arteriovenous-tension-difference-in-co2-under-hyperbaric-conditions-100630773","NCT07492030","Validation of the Use of the Arteriovenous Tension Difference in CO2 Under Hyperbaric Conditions","Use of Central Venous-arterial Carbon Dioxide Tension Difference to Diagnose Low Cardiac Output in Patients With Septic Shock Undergoing Hyperbaric Oxygen Therapy","SEPTICO2HBO","Inclusion Criteria:\n\n* Diagnosis of necrotizing fasciitis complicated by septic shock as defined by the Surviving Sepsis Campaign\n* Indication for HBOT according to the criteria of the 2016 European Consensus Conference\n* Patient intubated and ventilated prior to the HBOT session, receiving intravenous sedation at doses sufficient to be in a passive ventilation state\n* Patient equipped with a central venous line in the superior vena cava allowing central venous blood gas analysis\n* Patient with an arterial catheter allowing arterial blood gas analysis\n\nExclusion Criteria:\n\n* \\- Minors\n* Pregnant women\n* Persons deprived of their liberty (prisoners, persons under guardianship or trusteeship)\n* Persons not affiliated with or not covered by a social security system\n* Patients on spontaneous ventilation\n* Patients without an echocardiographic assessment window (anechoic)\n* Severe ARDS according to the Berlin classification\n* Technical impossibility of sampling central arterial or venous blood\n* Absolute contraindication to hyperbaric oxygen therapy (undrained pneumothorax, unstable angina or acute myocardial infarction, severe asthma attack)\n* Relative contraindication to hyperbaric oxygen therapy\n\n  * Respiratory: Chronic respiratory failure, severe pulmonary emphysema\n  * Circulatory: Rhythm or conduction disorders\n  * Neurological: uncontrolled epilepsy\n  * ENT: sinusitis, otitis, chronic rhinitis; laryngocele; acute otitis media; osteospongiosis\n  * Ophthalmic: retinal detachment",{"count":513,"type":22},74,"The central venous-arterial carbon dioxide tension difference is used daily in intensive care to establish peripheral tissue hypoperfusion, mainly mediated by a low cardiac index.\n\nThe partial pressures of gases (oxygen, carbon dioxide) increase in the blood of patients breathing 100% oxygen in hyperbaric conditions.\n\nThus, the validity of this biomarker in situations of acute circulatory failure during a hyperbaric oxygen therapy session has not been established.\n\nThe objective of the study is therefore to establish the diagnostic performance of the central venous-arterial carbon dioxide tension difference in the diagnosis of a low cardiac index in patients with septic shock undergoing hyperbaric oxygen therapy for necrotizing fasciitis.",[516,517,26],"Necrotizing Fascitis","Cellulitis",[519,520,521,522,523],"HBO","gapCO2","necrotizing fascitis","cellulitis","cardiac index","2026-05-11",{"date":496,"type":31},{"date":133,"type":22},{"date":528,"type":22},"2028-03-15",{"name":530,"class":38},"University Hospital, Lille",{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":537,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":39},"100638787","fluorescent-leukocytes-as-a-marker-of-early-sepsisseverity-100638787","NCT07585942","Fluorescent Leukocytes as a Marker of Early Sepsis\u002FSeverity","NEUTROPHIL FLUORESCENCE AS AN EARLY BIOMARKER OF SEPSIS SEVERITY IN THE EMERGENCY DEPARTMENT","FLAMES","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admission to the ED\n* Suspected or proven infection defined by the prescription of antibiotic therapy within 24 hours following admission to the ED\n* Collection of an EDTA blood sample as part of routine care\n* Patient informed and has not expressed opposition\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Legal protection measure (guardianship, curatorship, judicial protection)",{"count":358,"type":22},"Sepsis is a medical emergency whose prognosis depends on the early identification of patients at risk of septic shock, but the tools available in the Emergency Department remain insufficient. Neutrophils, key players in immunothrombosis, show alterations detectable via cell fluorescence (e.g., NE-SFL), which are strongly correlated with the severity of sepsis and septic DIC. The FLAMES study will evaluate, from the time of admission to the Emergency Department, the relevance of neutrophil fluorescence as an early biomarker of severity, either alone or integrated into an AI model based on the multiparametric data from the SthemA 801, with comparison to the Sysmex XN. It aims to address an unmet clinical need: the immediate stratification of the risk of severe forms of sepsis. Hypothesis: higher initial fluorescence will identify patients at risk of organ failure, septic shock, or DIC.",[106,361,26],"2026-05-06",{"date":496,"type":31},{"date":545,"type":22},"2026-05-12",{"date":547,"type":22},"2027-12-12",{"name":369,"class":38},{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":71,"phases":558,"briefSummary":559,"conditions":560,"keywords":563,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":4},"100639367","phase-2-nai-for-sepsis-with-persistent-lymphopenia-100639367","NCT07578558","NAI for Sepsis With Persistent Lymphopenia","Phase 2, Randomized, Open-Label Clinical Trial Evaluating Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care Alone in Critically Ill Adults With Sepsis and Persistent Lymphopenia","Inclusion Criteria:\n\n1. Age 18 years or older at the time of informed consent\n2. Admitted to the ICU with a diagnosis of sepsis as defined by Sepsis-3 criteria: life-threatening organ dysfunction caused by a dysregulated host response to infection, operationalized as a Sequential Organ Failure Assessment (SOFA) score increase of 2 or more points\n3. Documented persistent lymphopenia defined as ALC \\\u003C1,000 cells\u002FµL on at least two consecutive measurements within 72 hours of sepsis diagnosis (measurements must be separated by at least 12 hours)\n4. Prior initiation of appropriate antimicrobial therapy per institutional guidelines\n5. Ability to obtain written informed consent from the participant or legally authorized representative\n6. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males (for up to 7 months after completion of therapy)\n\nExclusion Criteria:\n\n1. Hematologic malignancies including leukemia, lymphoma, and myelodysplastic syndromes\n2. Prior CAR-T cell therapy or hematopoietic stem cell transplant (HSCT) within 3 months of screening\n3. Active cytokine release syndrome (CRS) at screening\n4. Current or recent (within 7 days) use of colony stimulating factors (G-CSF, GM-CSF)\n5. Lymphopenia attributable to chemotherapy, radiation therapy, or immunosuppressive medications administered within 30 days prior to screening\n6. High-dose immunosuppressive therapy (\\>0.5 mg\u002Fkg prednisone equivalent daily), excluding physiologic replacement and stress-dose hydrocortisone for septic shock\n7. Life expectancy less than 24 hours as assessed by the treating physician\n8. Active uncontrolled bleeding requiring \\>2 units of packed red blood cells in the preceding 24 hours\n9. Known HIV infection with CD4 count \\\u003C350 cells\u002FµL and detectable viral load\n10. Known active viral hepatitis (hepatitis B or C with detectable viral load)\n11. Advanced dementia or other conditions precluding meaningful participation\n12. Known hypersensitivity to any component of the investigational products\n13. Participation in another interventional trial with an investigational immunomodulatory agent within 30 days prior to screening\n14. Pregnant or breastfeeding",{"count":557,"type":22},50,[286],"This is a Phase 2, randomized, open-label study evaluating the safety and efficacy of nogapendekin alfa inbakicept (NAI, ANKTIVA®) in combination with standard of care versus standard of care alone in critically ill adults with sepsis and persistent lymphopenia. The study aims to determine whether NAI can improve 28-day mortality by addressing the immunosuppressive phase of sepsis characterized by persistent lymphopenia (absolute lymphocyte count \\\u003C1,000 cells\u002FµL). Participants will be randomized 1:1 to receive either NAI 1.2 mg subcutaneous injection on Days 3 (or earlier if ALC \\\u003C700 cells\u002FµL), Day 14, and potentially Day 21 if ALC remains \\\u003C1,000 cells\u002FµL, plus standard of care, or standard of care alone. The study will enroll approximately 50 participants (25 per arm) with persistent lymphopenia.",[106,26,561,562,156],"Lymphopenia","Immunosuppression",[106,77,564,562,565,566,567,568,569,570,571],"Persistent lymphopenia","IL-15 receptor agonist","Nogapendekin alfa inbakicept","N-803","ANKTIVA","Immune reconstitution","Critical care","ICU","2026-05-05",{"date":524,"type":31},{"date":575,"type":22},"2026-07-06",{"date":577,"type":22},"2027-10-04",{"name":579,"class":580},"ImmunityBio, Inc.","INDUSTRY",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":404,"enrollmentInfo":588,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":397},"100510617","evaluation-of-the-clinical-frailty-scale-cfs-as-a-risk-factor-of-mortality-in-adult-patients-65-years-of-age-admitted-to-intensive-care-for-septic-shock-100510617","NCT05928767","Evaluation of the Clinical Frailty Scale (CFS) as a Risk Factor of Mortality in Adult Patients ≤65 Years of Age Admitted to Intensive Care for Septic Shock.","Woodstock","Inclusion Criteria:\n\n* Patients aged ≥18 years and ≤ 65 years\n* Patient admitted to intensive care - resuscitation\n* Patient admitted for suspected or documented type 3 sepsis\n* Presence of vasopressor amines to maintain MAP \\> 65mmHg despite filling\n* Lactatemia ≥ 2 mmol\u002FL on admission.\n\nExclusion Criteria:\n\n* Patient moribund on admission\n* Patients with severe pre-existing dementia and\u002For cognitive decline, suffering from severe neurodegenerative diseases that prevent the patient from living independently at baseline, including mental illness requiring institutionalisation, including acquired or congenital mental retardation, etc.\n* Pregnant women or women in labour\n* Patients under guardianship or curatorship\n* Patients deprived of their liberty\n* Patient and\u002For family unable to speak or understand French.",{"count":284,"type":22},"The aim of the study is to demonstrate that \"frail\" patients, defined as having a CFS score greater than or equal to 5, and \"severely\" frail patients, defined as having a CFS score between \\[6-7\\] as defined by Bagshaw et al (14), constitute an independent risk factor (RF) for mortality.\n\nIn the same way, as an exploratory study, we will try to find out whether clinical frailty constitutes a risk factor for extending the length of hospital stay, the risk of short\u002Fmedium-term readmission, as has already been demonstrated for patients admitted to intensive care from all causes (15), or for impaired quality of life.\n\nThe objective is to have a better understanding of the implications and outcomes associated with pre-hospital frailty in young critically ill patients.\n\nThis analysis will also help to clarify prognoses and contribute to better decision-making on the intensity and proportionality of care, as well as providing better information and helping to manage the expectations of patients and their families in terms of survival prognosis and subsequent quality of life.",[591,26],"Frailty",{"date":593,"type":31},"2026-05-08",{"date":595,"type":31},"2023-08-21",{"date":597,"type":22},"2026-11",{"name":599,"class":38},"Centre Hospitalier de Lens",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":610,"conditions":611,"keywords":613,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":621,"completionDateStruct":622,"leadSponsor":623,"locationsCount":39},"100616030","validation-of-sofa-2-for-mortality-and-sepsis-3-prevalence-in-turkey-100616030","NCT07300306","Validation of SOFA-2 for Mortality and Sepsis-3 Prevalence in Turkey","Validation of the SOFA-2 Score for 30-Day Mortality in Intensive Care Units in Turkey and Determination of Sepsis-3 Prevalence - A Multicenter Hybrid Observational Study.","TURK-SOFA2","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Admitted to the Intensive Care Unit (ICU) during the specified study recruitment window.\n* For the Validation Cohort: Patients staying in the ICU for at least 24 hours.\n* For the Point Prevalence Cohort: Patients present in the ICU at 08:00 AM on the designated \"Index Day\" or admitted within the subsequent 24 hours.\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age.\n* Patients admitted to Pediatric Intensive Care Units.\n* Patients admitted to Coronary Care Units (CCU).\n* Patients admitted to Cardiovascular Surgery Intensive Care Units.\n* Patients admitted solely for the purpose of organ donation.\n* Patients with missing core data components required for score calculation.",{"count":609,"type":22},2500,"The goal of this observational study is to validate the effectiveness of the new SOFA-2 score in predicting mortality and to determine the current frequency of sepsis in adult patients admitted to Intensive Care Units (ICUs) in Turkey. The main questions it aims to answer are:\n\n* Does the SOFA-2 score accurately predict 30-day mortality in ICU patients?\n* What is the prevalence of Sepsis-3 and septic shock in Turkish ICUs?\n\nResearchers will compare the new SOFA-2 score to the existing SOFA-1 score to see if the new score provides better predictive accuracy for patient outcomes.\n\nParticipants will not receive any experimental intervention. Researchers will collect data from routine medical care, including:\n\n* Vital signs, laboratory test results, and details of organ support (such as mechanical ventilation or dialysis) during the first 24 hours of admission.\n* Survival status at 30 days.",[106,26,156,612],"Organ Dysfunction",[614,615,446,616,617,618],"SOFA-2 Score","Sepsis-3","Mortality Prediction","Organ Failure Assessment","Validation Study","2026-05-04",{"date":593,"type":31},{"date":619,"type":31},{"date":323,"type":22},{"name":624,"class":38},"Marmara University",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":71,"phases":635,"briefSummary":636,"conditions":637,"keywords":638,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":645,"locationsCount":647},"100619329","early-norepinephrine-administration-and-rapid-dose-adjustment-100619329","NCT07343206","Early Norepinephrine Administration and Rapid Dose Adjustment","Efficacy of Early Norepinephrine Administration and Rapid Dose Adjustment in Adult Septic Shock Patients: A Multicenter Randomized Controlled Trial","CENSER2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Sepsis: SOFA ≥2 with suspected infection\n* Mean arterial pressure \\\u003C65 mmHg\n* Diagnosed within 3 hours\n\nExclusion Criteria:\n\n* Do-not-resuscitate orders\n* Pregnancy\n* Severe concurrent conditions (acute stroke, acute coronary syndrome, acute pulmonary edema, status asthmaticus, active gastrointestinal bleeding, status epilepticus, severe burn, severe trauma, and fatal drug overdose, End-stage malignancy\n* Peripheral arterial disease\n* Prior norepinephrine administration\n* Recurrent shock in the same patient",{"count":634,"type":22},600,[73],"The goal of this clinical trial is to determine whether early initiation of norepinephrine with rapid dose adjustment improves clinical outcomes in adult patients with septic shock. The study aims to evaluate the effect of early norepinephrine administration on mortality, hemodynamic stabilization, and resuscitation efficiency in adults aged 18 years and older diagnosed with septic shock.\n\nThe main questions it aims to answer are:\n\n* Does early norepinephrine administration with rapid dose titration reduce 28-day mortality compared with standard treatment?\n* Does early norepinephrine administration with rapid dose tiration lead to faster shock control and reduced fluid requirements without increasing treatment-related adverse events?\n\nResearchers will compare early norepinephrine administration with rapid dose adjustment to placebo with standard sequential resuscitation and rescue norepinephrine as needed to see if early vasopressor initiation improves survival, shock resolution, and safety outcomes.\n\nParticipants will:\n\n* Receive either norepinephrine or placebo infusion initiated within one hour of septic shock diagnosis, with dose adjustment every 15 minutes according to a standardized protocol\n* Undergo close hemodynamic and safety monitoring, including frequent vital sign assessment and limb perfusion evaluation\n* Receive standard sepsis care, including fluid resuscitation, antibiotics, and organ support as clinically indicated\n* Be followed for clinical outcomes and adverse events for up to 28 days after enrollment",[106,26],[160,242,265,241],"2026-04-21",{"date":641,"type":31},"2026-04-22",{"date":643,"type":31},"2026-01-01",{"date":299,"type":22},{"name":646,"class":38},"Siriraj Hospital",6]