[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-inflammatory-response-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-inflammatory-response-syndrome":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,63,100,125,147,177,201,225,241,272,307,333,364],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100568680","phase-1-study-on-safety-and-efficacy-of-two-doses-of-prs-ck-storm-in-the-modulation-of-the-cytokine-storm-in-patients-with-acute-respiratory-infection-caused-by-sars-cov-2-influenza-a-influenza-b-and-respiratory-syncytial-virus-rsv-100568680",false,"NCT06684379","Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)","Double-blind, Randomized, Placebo-controlled, Pilot Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Two Doses of a Conditioned Medium From a Co-culture of M2-macrophages and Fat-derived Mesenchymal Cells (PRS CK STORM) in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)","Inclusion Criteria:\n\n1. Signed informed consent by the participant or legal representative prior to the initiation of any study-specific procedure.\n2. Males and females aged ≥ 18 years old at the time of the consent.\n3. Confirmed diagnosis of SARS-CoV-2, influenza virus A, influenza virus B or RSV pneumonia by positive RT-PCR (results of a PCR prior to screening will be valid only if the PCR has been done for all 4 viruses and in 3 days prior to the screening visit). PCR will include the analysis of SARS-Cov-2, influenza A, influenza B and RSV.\n4. Diagnosis of systemic inflammatory response syndrome (SIRS), defined by the satisfaction of any two of the criteria below:\n\n   1. Body temperature over 38 ºC or under 36 ºC.\n   2. Heart rate greater than 90 beats\u002Fminute.\n   3. Respiratory rate higher than 20 breaths\u002Fmin or PaCO2 lower than 32 mmHg.\n   4. Leukocyte count higher than 12000\u002FμL, lower than 4000\u002FμL or over 10% immature forms or bands.\n5. Need for oxygen therapy.\n6. Female participants must be, either surgically sterilized or at least 1 year postmenopausal (confirmed by follicle-stimulating hormone \\[FSH\\] more than 20 international units \\[Ius\\] only for women under 54) or using adequate birth control (hormonal contraception, intrauterine contraceptive device, double barrier methods \\[condom with spermicide, diaphragm with spermicide, or condom and diaphragm\\]) or sexual abstinence for up to 90 days after the last treatment administration. Male participants must be willing to use barrier contraception (condom) for up to 90 days after the last treatment administration.\n\nExclusion Criteria:\n\n1. Failure to perform screening or baseline examinations.\n2. Body Mass Index (BMI) more than or equal to 35.\n3. Irreversible critical condition, as assessed by the investigator.\n4. Active autoimmune diseases or severe immunosuppression, unless stable and controlled for at least 3 months prior to the inclusion in the study.\n5. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias the clinical assessment, such as:\n\n   1. Liver function test abnormalities or other signs of hepatic insufficiency not justified by a pulmonary acute inflammation process: Aspartate transaminase (AST), alanine transaminase (ALT) more than 3 per upper limit of the reference range, total bilirubin more than or equal to 2 mg\u002FdL; except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome.\n   2. Renal insufficiency (serum creatinine more than 2 mg\u002FdL (more than 150 μmol\u002FL) and creatinine clearance less than 30 (according to Cockcroft-Gault formula).\n   3. Myocardial infarction, unstable angina, heart failure within 3 months before screening.\n   4. Bradycardia (heartbeat less than 50\u002Fmin).\n   5. Atrioventricular block (type II \u002F Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcF interval (males more than 450 msec and females more than 470 msec using Fridericia's formula: QTc = QT\u002F RR\\^2 ).\n   6. Uncontrolled diabetes mellitus (blood glucose level above 500 mg\u002FdL) at the time of admission.\n   7. Malignant tumors within the last 5 years, unless stable during that time. Skin malignancies (other than melanoma) and indolent prostate cancer are excluded from this criterion.\n   8. Metastases.\n   9. Human Immunodeficiency Virus (HIV), HBV \\[hepatitis B surface antigen (HBs Ag) positive (+), or detected sensitivity on the HBV deoxyribonucleic acid (DNA), polymerase chain reaction (PCR) qualitative test for hepatitis B core antibody (HBc Ab) positive subjects\\] or HCV \\[HCV ribonucleic acid (RNA) detectable in any subject with positive anti-HCV antibody (HCV Ab)\\].\n6. Inability to comply with the study and monitoring procedures.\n7. Pregnant and breastfeeding females (pregnancy test positive).\n8. Suspected or known active drug or alcohol abuse.\n9. Enrollment in another investigational drug study within 1 month before the screening\n10. Subject who has any condition, including any psychological or psychiatric condition, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of two doses (dose A and dose B) of Standardized Conditioned Medium Obtained by Coculture of M2-macrophages and fat-derived Mesenchymal Stromal Cells (PRS CK STORM) in the modulation of the cytokine storm in participants with acute respiratory infection caused by SARS-Cov-2, influenza A, influenza B and respiratory syncytial virus (RSV) in need for oxygen therapy.\n\nThe main questions it aims to answer are:\n\n* Are both doses of PRS CK STORM (dose A and dose B) safe as an intravenous drug to modulate inflammatory processes, such as the cytokine storm in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV?\n* Are both doses of PRS CK STORM (dose A and dose B) effective as an intravenous drug to modulate SIRS-associated cytokine storm caused by SARS-Cov-2, influenza A, influenza B and RSV compared to the control group?\n* What are the anti-inflammatory and pro-inflammatory cytokine profiles after treatment with two different doses of PRS CK STORM in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV?\n\nResearchers will compare both doses of PRS CK STORM with the control group to test whether the anti-inflammatory action of PRS CK STORM is safe and effective in modulating the cytokine storm for the treatment of SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV. In addition, the anti-inflammatory and pro-inflammatory cytokine profiles after treatment PRS CK STORM compared to placebo group in these participants will be also studied.",[27,28,29,30,31],"SARS-CoV-2","Influenza, Human","Respiratory Syncytial Virus Infections","Respiratory Distress Syndrome","Systemic Inflammatory Response Syndrome",[33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,31],"SARS-CoV-2 infection","Causing atypical respiratory disease (COVID-19)","2019 Novel Coronavirus","COVID-19 Virus","SARS Coronavirus 2","COVID-19-associated cytokine storm","Lung Diseases","Pneumonia","M2-macrophages","Mesenchymal cells","Influenza A Virus","Influenza B Virus","RSV Infection","Acute Respiratory Distress Syndrome","ARDS, Human","Respiratory Distress Syndrome, Acute","Cytokine storm","RECRUITING","2026-06-05",{"date":53,"type":54},"2026-06-10","ACTUAL",{"date":56,"type":54},"2024-10-02",{"date":58,"type":20},"2026-10-02",{"name":60,"class":61},"PEACHES BIOTECH","INDUSTRY",3,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":73,"conditions":74,"keywords":82,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100201862","clinical-microbial-species--antibiotic-resistance-id-in-ed-patients-presenting-with-infection---is-rapid-id-possible--accurate-100201862","NCT01904188","Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?","Clinical Microbial Species and Antibiotic Resistance Identification in Patients Presenting to the Emergency Department With Three of Four Systemic Inflammatory Response Syndrome (SIRS) Criteria - is Rapid Identification Possible and Accurate?","Inclusion Criteria:\n\nAdult patients with 3 of 4 systemic inflammatory response syndrome (SIRS) characteristics (1. tachycardia, 2. fever or hypothermia, 3. tachypnea, 4. leukocytosis), who have blood cultures drawn and\u002For urine collected for the evaluation of suspected sepsis, and\u002For other bodily fluids collected for culture and sensitivity analysis.\n\nPatients with other sources of infection with less than 3 of 4 SIRS criteria including sputum, wound drainage, CSF, nasal or oral secretions.\n\nExclusion Criteria:\n\nPediatric patients",{"count":71,"type":20},2500,"OBSERVATIONAL","The aim of this project is to test the utility of The Gene Z device (as of 2018 Gene Z no longer being used), now using In-Dx and other rapid identification techniques that the investigators have developed in the lab on clinically obtained bodily fluid samples taken from patients with suspected infection or sepsis based on having three of four positive Systemic Inflammatory Response Syndrome markers, or having a known infection for which a specimen is being collected. Specimens will be collected at the University of Michigan Health\u002FSparrow and McLaren Greater Lansing , processed in our lab and stored for analysis at a later date to determine if the microbial pathogens identified by current methods of culture, as well as pathogen susceptibility to antibiotics by culture results, can be identified by the GeneZ technology (no longer in use) or other developed technology accurately, and more timely. It will not affect current patient care nor impact patient care, which will continue in the standard fashion today for sepsis. Results will be compared to standard culture results and antibiotic sensitivities. A secondary aim is related to the antibiotic resistance of the organism causing the infection in an attempt to determine if there are specific characteristics of the organism that allow it to be resistant to certain antibiotics. This requires analysis of the genetic material of the organism in our laboratory. Because there are also human cells in the specimens collected, with separate permission we will evaluate the human genome of the patient with the infection to determine characteristics and conditions that may predict a complicated versus uncomplicated disease course.",[75,31,76,77,78,79,80,81],"Sepsis","Infection Mixed","Infection, Bacterial","Infection, Fungal","Infection, Coronavirus","Antibiotic Resistance Genes","Human Genome Analysis",[83,84,85,86,31,87,88],"microbial identification","antibiotic resistance","In-Dx and other methods as developed","sepsis","antibiotic resistance genes","human genome analysis","2026-06-04",{"date":91,"type":54},"2026-06-08",{"date":93,"type":4},"2015-06",{"date":95,"type":20},"2032-07",{"name":97,"class":98},"Michigan State University","OTHER",2,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":99},"100490214","determinants-of-vascular-leakage-during-systemic-inflammatory-response-syndrome-100490214","NCT05663216","Determinants of Vascular Leakage During Systemic Inflammatory Response Syndrome","SIRS-PERM","Inclusion Criteria:\n\n* All patients admitted in the European Georges Pompidou Hospital or La Pitié-Salpêtrière ICU, and exhibiting a systemic inflammatory response syndrome (SIRS), characterized by the following items:\n\n  * Temperature \\> 38°C ou \\\u003C36°C\n  * Heart rate \\>90\u002Fmin\n  * Respiratory rate \\>20\u002Fmin or PaCO2\\\u003C32mmHg\n  * White cell count \\> 12 000\u002Fmm3 ou \\\u003C 4 000\u002Fmm3\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Decline to participate\n* Pregnancy\n* Cirrhosis Child-Pugh \\> B\n* Denutrition with BMI\\\u003C15kg\u002Fm2\n* Nephrotic syndrome\n* Persons deprived of their liberty by a judicial or administrative decision (guardianship or tutelage measure)",{"count":108,"type":20},180,"BACKGROUND Controlling vascular leakage, which is independently associated with mortality during Sepsis and cardiogenic shock, may be a promising approach during systemic inflammatory response syndrome (SIRS). During a collaborative work between La Pitié-Salpêtrière intensive care unit (ICU) and the unit INSERM U1050 (National Institute oh Health and medical Research), we identified 38 genes associated with capillary leakage during systemic inflammation response syndrome (SIRS) in humans. The aim of this study is to evaluate their possible implication in vascular hyperpermeability associated with\n\nMETHODS SIRS-PERM is a prospective multicenter cohort study, testing the correlation between the plasma and broncho-alveolar levels of proteins isolated from our first screening, and the level of vascular leakage during SIRS. All patients admitted in the European Georges-Pompidou or La Pitié-Salpêtrière ICU and presenting a SIRS will be eligible for inclusion. Plasma samples will be collected at day 0, D1, D3 and D7, as well as broncho-alveolar lavage samples if clinically indicated. Concentration of each protein will be determined by ELISA in those samples. A statistical association will be then tested between each protein concentration and, for each time-point, the level of capillary leakage (daily weight and fluid balance, extra-vascular lung water index and pulmonary permeability index measured by transpulmonary thermodilution), and ARDS (acute respiratory distress syndrome) severity (PaO2\u002FFiO2 ratio, Murray score and pulmonary compliance). Its link with hemodynamic status, the level of multiple organ failure, and vital status at day 30, will be also assessed. Basing the calculation of the sample size on the variations of VEGF (Vascular endothelial growth factor) expression in our first screening cohort, we calculated a sample size of 180 patients for this study, for a total duration of the study of 5 years.\n\nIMPLICATIONS: SIRS-PERM will assess the determinants of capillary leakage during SIRS. It may thus provide a better understanding of the pathophysiology of this disease, with the goal to isolate new markers of severity, as well as new therapeutic targets to treat it. Modulating specifically capillary leakage is indeed a totally new approach during this pathology.",[31],[112,113,114,115],"Systemic inflammatory response syndrome","Vascular leakage","Capillary leakage","fluid balance","2025-12-02",{"date":118,"type":54},"2025-12-09",{"date":120,"type":54},"2023-05-31",{"date":122,"type":20},"2028-07-01",{"name":124,"class":98},"Assistance Publique - Hôpitaux de Paris",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":131,"maxAge":17,"enrollmentInfo":132,"targetDuration":133,"studyType":72,"phases":4,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":99},"100213403","modulation-of-molecular-fingerprinting-in-pediatric-sepsis-100213403","NCT02055105","Modulation of Molecular Fingerprinting in Pediatric Sepsis","Inclusion Criteria:\n\n* Age 1 through 18 years\n* Patients admitted to the PICU with concerns for sepsis or those developing sepsis during their admission to the hospital.\n* Patients must be enrolled int he study from arrival time tot he ED up to 24 hours from the time of initiation of antibiotic therapy for treatment of sepsis or septic shock.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients \\\u003C1 year of age and greater than 18 years of age.","1 Year",{"count":19,"type":20},"5 Days","The goal of this study is to demonstrate the sensitivity and specificity of detecting circulating micro RNA (miRNA) biomarkers in pediatric septic patients. It will also follow expression and modulation of levels in response to therapy in comparison to current biomarkers.",[31],[137],"Pediatric Sepsis","2025-11-07",{"date":140,"type":54},"2025-11-12",{"date":142,"type":4},"2014-03",{"date":144,"type":20},"2027-10",{"name":146,"class":98},"Phoenix Children's Hospital",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":154,"sex":16,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100609980","conventional-ultrafiltration-versus-dilutional-ultrafiltration-in-pediatric-cpb-patients-100609980","NCT07221630","Conventional Ultrafiltration Versus Dilutional Ultrafiltration in Pediatric CPB Patients","Effects of Conventional and Dilutional Ultrafiltration Techniques During Cardiopulmonary Bypass in Pediatric Cardiac Patients","Inclusion Criteria:\n\n* Males and females less than 5 years of age\n* Cardiac operations utilizing CPB\n* Cardiac reoperations utilizing CPB\n\nExclusion Criteria:\n\n* Patients greater than 5 years of age.\n* Any active SYSTEMIC noncardiac disease expected to raise patient baseline CRP levels to above normal levels (\\>1mg\u002FdL). Since CRP levels correlate with the severity of most skin disease, patients with active dermatitis issues on the day of surgery will be excluded from the study. Patients with autoimmune diseases including RA, SLE, IBD (Crohn's disease, ulcerative colitis), Kawasaki disease and patients experiencing active infections will be excluded from the study.\n* Any noncardiac disease not well controlled (ex. Asthma not properly controlled with medication, etc.)\n* Recent viral illness (ex. Positive COVID\u002Fflu test 30 days prior to surgery)\n* All patients receive solumedrol (10mg\u002Fkg dose) from anesthesia as part of the prebypass protocol. Any patient currently taking steroids will also be excluded from the study\n* Non-cardiopulmonary bypass cases (Off pump CoA, Vascular ring surgery, etc.)\n* ECMO patients\n* Emergent cases",true,"1 Day","5 Years",{"count":158,"type":20},100,"The investigators will be comparing two different filtration methods on cardiopulmonary bypass for pediatric heart surgery patients. Three blood tests will be taken from the patient to compare which filtration method is better at decreasing post-cardiopulmonary bypass inflammation caused by the heart-lung machine.",[31],[162,163,164,165],"Dilutional Ultrafiltration","Conventional Ultrafiltration","Cardiopulmonary Bypass","C-reactive protein","NOT_YET_RECRUITING","2025-10-27",{"date":169,"type":54},"2025-10-28",{"date":171,"type":20},"2026-01-01",{"date":173,"type":20},"2027-01-02",{"name":175,"class":98},"Akron Children's Hospital",1,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":154,"sex":16,"minAge":183,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":176},"100600736","phase-1-a-comparative-study-between-dexmedetomidine-versus-methylprednisolone-on-induced-inflammatory-response-in-patients-undergoing-on-pump-cabg-100600736","NCT07101367","A Comparative Study Between Dexmedetomidine Versus Methylprednisolone on Induced Inflammatory Response in Patients Undergoing On-pump CABG","Inclusion Criteria:\n\n1. Age 21-60 years.\n2. Sex: Both sexes.\n3. American Society of Anaesthesiologists (ASA) Physical Status Class II, and III.\n4. Scheduled for CABG on cardio-pulmonary bypass.\n\nExclusion Criteria:\n\n1. Declining to give a written informed consent.\n2. History of allergy to the medications used in the study.\n3. Psychiatric disorders.\n4. Significant cognitive dysfunction.\n5. American Society of Anesthesiologists (ASA) Physical Status Class IV.\n6. Chronic liver or kidney disease.\n7. Poor systolic function ( Ejection fraction \\\u003C 40% ).\n8. Pregnancy.\n9. Redo CABG.\n\n9.Infection during the week preceding surgery white blood cell count over 11,000 mm3 10.Pre-operative use of antibiotics or corticosteroids.","21 Years","60 Years",{"count":186,"type":20},60,[23,24],"A comparison between precedex versus solumedrol as anti-inflammatory stress response inhibitors in patients undergoing on-pump CABG using different inflammatroy response parameters and the outcome of the drugs on the cognitive and cardiac status post extubation",[190,31,191],"Coronary Artery Disease","Postoperative Complications","2025-08-01",{"date":194,"type":54},"2025-08-06",{"date":196,"type":20},"2025-09-01",{"date":198,"type":20},"2026-08-31",{"name":200,"class":98},"Ain Shams University",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":209,"targetDuration":211,"studyType":72,"phases":4,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":176},"100407073","extracorporeal-blood-purification-therapy-in-critically-ill-patients-globalarrt-100407073","NCT04580680","Extracorporeal Blood Purification Therapy in Critically Ill Patients (GlobalARRT)","Extracorporeal Blood Purification Therapy in Critically Ill Patients: an Interactive,Web-based,Multicenter,Observational Prospective Registry","GlobalARRT","Inclusion Criteria: patients who meet all the following inclusion criteria may be included in this study:\n\n1. Admission to ICU\n2. Indications for at least one of the following extracorporeal blood purification treatments:\n\n   1. Continuous Renal Replacement Therapy (CRRT) \u002F Intermittent Hemodialysis (IHD) \u002F Hybrid therapies for renal support\u002Freplacement;\n   2. Immunomodulation therapy in critically ill patients using hemodiafilters with larger pore sizes characterized by enhanced transmembrane clearance of larger molecules (such as cytokines), hemodiafilters with enhanced unselective absorption of cytokines and\u002For endotoxins, cartridges with enhanced absorption of cytokines and\u002For endotoxins, techniques aimed at improving extracorporeal removal of cytokines and\u002For endotoxins.\n\nIt should be underlined that the lack of established guidelines on the use of membranes for extracorporeal blood purification (and on RRTs in general) leads to variability in clinical practice and treatments are initiated in accordance with the judgement of the responsible physician. Under these circumstances, it is preferable to keep inclusion criteria as wide as possible so as to obtain a real picture of clinical practice worldwide.\n\nExclusion Criteria: besides contraindications to the use of the EBP adopted (as from the manual of instructions), there are no exclusion criteria.",{"count":210,"type":20},1000,"10 Days","Worldwide, the use of Extracorporeal Blood Purification (EBP) in everyday clinical practice is becoming increasingly common, particularly in critical care settings. The efficacy of most of these treatments on removal of inflammatory mediators is the main rationale behind the use of EBP in critically ill patients with multiorgan dysfunction. Nonetheless, there are still some doubts as to the clinical efficacy of bacterial toxins and cytokines removal and many clinical trials aiming at exploring the effect of EBP on long-term outcomes of septic patients have failed to demonstrate consistent results regarding 28 day- or hospital-mortality rates. The primary aim of this observational prospective web-based registry is to define the possible clusters of critically ill patients - treated with extracorporeal blood purification therapies worldwide - who are homogeneous regarding both clinical and treatment characteristics and seem to benefit the most from EBP.",[214,215,75,31],"Critical Illness","Acute Kidney Injury","2025-02-11",{"date":218,"type":54},"2025-02-12",{"date":220,"type":54},"2020-11-01",{"date":222,"type":20},"2025-09-30",{"name":224,"class":98},"Careggi Hospital",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":232,"targetDuration":211,"studyType":72,"phases":4,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":239,"locationsCount":240},"100365052","use-of-ebpt-in-critically-ill-patients-with-aki-andor-multiorgan-failure-100365052","NCT04033224","Use of EBPT in Critically Ill Patients With AKI and\u002For Multiorgan Failure","Use of EBPT in Critically Ill Patients With AKI and\u002For Multiorgan Failure: a Multicenter Prospective Observational Registry","Inclusion Criteria:\n\n* critically ill patients in the ICU\n* one of this EPB therapy:\n* CRRT\u002FIHD\u002FHybrid therapies for support\u002F\u002Freplacement renal function\n* immunomodulation achieved by \"high cut-off membranes\", \"endotoxins and\u002For cytokines adsorbent membranes\" or by high-volume hemofiltration\n\nExclusion Criteria:\n\n* patients treated only by Cytosorb® and\u002For Toraymyxin® therapies",{"count":210,"type":20},"The use of extracorporeal blood purification therapies (EBPT) is becoming increasingly widespread worldwide in everyday clinical practice, particularly in the critical care setting. Nonetheless, most of the clinical trials aimed at exploring the effect of EBPT on patients' long-term outcomes have failed to demonstrate consistent results regarding 28 day- or hospital- mortality rates. The aim of this observational prospective registry is to evaluate if there is a cluster of critically ill patients that mostly benefits from extracorporeal blood purification therapies with different EBPTs.",[214,215,75,31],{"date":218,"type":54},{"date":237,"type":54},"2019-07-16",{"date":222,"type":20},{"name":224,"class":98},15,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":21,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":176},"100520120","phase-1-cell-therapy-with-treg-cells-obtained-from-thymic-tissue-thytreg-to-control-the-immune-hyperactivation-associated-with-covid-19-andor-acute-respiratory-distress-syndrome-thytech2-100520120","NCT06052436","Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation Associated With COVID-19 and\u002For Acute Respiratory Distress Syndrome (THYTECH2)","Open Phase I\u002FIIa Clinical Trial to Evaluate the Safety and Efficacy of Allogenic Administration of Treg Cells Obtained From Thymic Tissue (thyTreg) to Control The Immune Hyperactivation Associated With COVID-19 and\u002For Acute Respiratory Distress Syndrome","THYTECH2","Inclusion Criteria:\n\n1. Patient over 18 to 65 years of age\n2. Patient Informed and non-opposed to the research by his medical doctor during hospitalization\n3. Patient with clinical, radiological, gasometric and immunological criteria defined as:\n\n   1. Acute respiratory failure secondary to acute lung injury of noncardiogenic cause\n   2. Pulmonary abnormalities compatible with bilateral alveoloinsterstitial infiltrates by chest imaging (radiograph or scan)\n   3. PaO2\u002FFiO2≤ 300 Presence of at least one of the following markers of inflammation: IL6 \\> 40 pg\u002Fml or ferritin \\>300 ng\u002Fml or CRP \\>3 mg\u002Fdl or increasing over the last 24 hours\n\nExclusion Criteria:\n\n1. Pregnancy or breast feeding\n2. Body mass index \\>35\n3. Patients not expected to survive 48 hours after enrolment based on clinical assessment\n4. Patients with an extracorporeal respiratory support\n5. Neutropenia (absolute neutrophil count \\\u003C1000\u002FuL)\n6. Thrombocytopenia (absolute neutrophil count \\\u003C50000\u002FuL)\n7. Positive serology for HBV, HCV, or HIV at Screening\n8. Life expectancy of less than 6 months due to other pathologies\n9. History of significant underlying pulmonary disease requiring oxygen therapy prior to inclusion.\n10. Patients with a history of autoimmune diseases\n11. Patients with a history of hematopoietic neoplasia or oncology disease\n12. Patients with a history of hematopoietic or solid organ transplant\n13. Patients with a congenital or induced immunodeficiency\n14. Patients received thymoglobulin, basiliximab or any anti-T-cell therapies within 6 moths prior to the screening visit\n15. Patients received other cell therapy in the last 12 months\n16. Patients received intravenous immunoglobulin (IVIg) within 5 moths prior to the screening visit\n17. Patients who have participated or is participating in a clinical research study evaluating COVID-19 or ARDS within 30 days prior to the screening visit","65 Years",{"count":251,"type":20},24,[23,24],"The investigators developed a GMP protocol to isolate Treg cells from thymic tissue (thyTreg). The thyTreg cells are being evaluated in a Phase I\u002FII clinical trial to evaluate the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children (NCT04924491), with preliminary results indicating the feasibility and safety of the therapy.\n\nIn addition, thyTreg cells have shown low immunogenicity in the pre-clinical setting, indicating that allogeneic use of these thyTreg cells (allo-thyTreg) would have a low risk of adverse effects. These thyTreg cells could inhibit an excessive inflammation in SARS-CoV-2 infection, or ameliorate the immunological affection underlying Acute respiratory distress syndrome, improving life-threatening manifestations, restoring immune balance, and protecting affected tissues.\n\nThis clinical trial is an open-label Sequential Parallel Group Phase I\u002FII study to evaluate the safety and efficacy of allogeneic thymus derived Tregs (thyTreg) (thyTreg) in controlling the immune dysregulation associated with SARS-CoV-2 infection and\u002For Acute Respiratory Distress Syndrome.",[31],[256,257,258,259,260,261,262],"Immune Hyperactivation","Regulatory T cell","ARDS","COVID-19","Advanced therapy","Immunotherapy","Th1-Th2 Balance","2025-01-30",{"date":265,"type":54},"2025-02-03",{"date":267,"type":54},"2023-06-27",{"date":269,"type":20},"2027-12-31",{"name":271,"class":98},"Hospital General Universitario Gregorio Marañon",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":21,"phases":282,"briefSummary":283,"conditions":284,"keywords":290,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":99},"100513730","phase-2-umbilical-mesenchymal-stromal-cells-as-cellular-immunotherapy-for-septic-shock-100513730","NCT05969275","Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock","Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock: A Multi-Center, Double Blind, Phase II Randomized Controlled Trial","UC-CISSII","Inclusion Criteria:\n\nA participant must meet all the following inclusion criteria at time of randomization to be eligible:\n\n1. At least 18 years of age AND\n2. Requirement for admission to the intensive care unit AND\n3. Index admission to the intensive care unit AND\n4. Cardiovascular organ failure for at least 1 consecutive hour defined by the requirement of at least 5 mcg\u002Fmin of norepinephrine or 100 mcg\u002Fmin of phenylephrine or 0.03 U\u002Fmin vasopressin AND\n5. Clinician impression that cardiovascular organ failure is related to infection AND\n6. There is at least 1 other acute organ failure according to modified individual Sequential Organ Failure Assessment Scores within 24 hours of meeting Cardiovascular organ failure defined by:\n\n   1. Respiratory failure: invasive or non-invasive mechanical ventilation with a positive end expiratory pressure (PEEP) \\>\u002F= 5 cm H2O and a partial pressure of oxygen\u002Ffractional inspired oxygen concentration (P\u002FF ratio \\\u003C\u002F= 200), OR high-flow nasal canula oxygen therapy (minimum total flow rate of 30 lpm and 40% FiO2); OR\n   2. Hematological failure: platelet count of \\\u003C\u002F= 100 X 10\\^9\u002FL OR\n   3. Acute kidney injury: acute renal insufficiency with a creatinine of \\>\u002F= 200 umol\u002FL, or the requirement for new renal replacement therapy, or for participants with known chronic renal failure but not on dialysis, a 50% increase in their baseline creatinine concentration OR\n   4. Organ hypoperfusion: a lactate \\>\u002F= 4 mmol\u002FL\n\nAcute organ failures that meet eligibility criteria must not have been present for greater than 48 hours prior to meeting the eligibility criteria.\n\nExclusion Criteria:\n\nPatients will be excluded if they have at least one of the following at time of randomization:\n\n1. Another form of shock (cardiogenic, hypovolemic, obstructive) OR\n2. History of known chronic pulmonary hypertension with a WHO functional class of IV OR\n3. History of severe chronic pulmonary disease requiring home oxygen OR\n4. History of severe chronic cardiac disease including congestive heart failure or valvular dysfunction with a New York Heart Association Functional class IV or severe chronic ischemic heart disease with a Canadian Cardiovascular Society angina class score IV OR\n5. History of severe chronic liver disease (Child-Pugh Class C or model for end stage liver disease (MELD) Score \\>= 15) OR\n6. Malignancy in previous 1 year (excluding resolved non-melanoma skin cancer) OR\n7. Treating physician impression that death is imminent within the 12 hours after meeting eligibility criteria OR\n8. Pregnant or lactating OR\n9. Family or patient not committed to aggressive care",{"count":281,"type":20},296,[24],"Septic shock is associated with substantial burden in terms of both mortality and morbidity for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem (stromal) cells (MSCs) modulate inflammation, enhance pathogen clearance and tissue repair and reduce death. Our team has completed a Phase I dose escalation and safety clinical trial that evaluated MSCs in patients with septic shock. The Cellular Immunotherapy for Septic Shock Phase I (CISS) trial established that MSCs appear safe and that a randomized controlled trial (RCT) is feasible. Based on these data, the investigators have planned a phase II RCT (UC-CISS II) at several Canadian academic centres which will evaluate intermediate measures of clinical efficacy (primary outcome), as well as biomarkers, safety, clinical outcome measures, and a health economic analysis (secondary outcomes).",[285,75,286,287,31,288,289],"Septic Shock","Pathologic Processes","Shock","Inflammation","Infections",[291,292,293,294,295,296,297,75,285],"Mesenchymal Stem Cells","Mesenchymal Stromal Cells","Randomized Controlled Trial","Cryopreserved","Allogeneic","Umbilical Cord","Phase II","2024-12-04",{"date":300,"type":54},"2024-12-05",{"date":302,"type":54},"2024-02-14",{"date":304,"type":20},"2027-03-31",{"name":306,"class":98},"Ottawa Hospital Research Institute",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":21,"phases":317,"briefSummary":319,"conditions":320,"keywords":323,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":99},"100531090","protective-effect-of-sivelestat-against-negative-pulmonary-function-and-organ-dysfunction-after-cardiovascular-surgery-panda-vi-100531090","NCT06195267","Protective Effect of Sivelestat Against Negative Pulmonary Function and Organ Dysfunction After Cardiovascular Surgery (PANDA VI)","PANDA","Inclusion Criteria:\n\n* The patients are conformed to 2010 ACC\u002FAHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset;\n* Patients with type A acute aortic syndrome confirmed clinically and radiologically and planning to undergo emergency surgery were enrolled.\n* The patients' age between 18 \\~90 years old.\n* Agree to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* Patients allergic to sivelestat sodium;\n* Lactating women and pregnant women;\n* Patients with mental diseases, drug and alcohol dependence;\n* Refuse to participate in this study and refuse to sign the informed consent.","90 Years",{"count":316,"type":20},500,[318],"NA","Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major causes of death in patients with cardiovascular diseases. Therefore, the prevention of SIRS and MODS is of great clinical value, and immunomodulatory therapy with sivelestat may be beneficial. This study was designed to test the hypothesis that the administration of sivelestat during the acute phase of cardiovascular diseases will result in a reduced incidence of SIRS and MODS.",[321,31,322],"Aortic Dissection","Cardiovascular Diseases (CVD)",[31],"2024-11-20",{"date":326,"type":54},"2024-11-22",{"date":328,"type":54},"2024-07-01",{"date":330,"type":20},"2025-12-31",{"name":332,"class":98},"Nanjing Medical University",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":21,"phases":343,"briefSummary":344,"conditions":345,"keywords":348,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":176},"100552797","inflammatory-response-and-oxidative-stress-in-cardiac-surgery-min-invasive-vs-conventional-extracorporeal-circulation-100552797","NCT06477757","Inflammatory Response and Oxidative Stress in Cardiac Surgery: Min. Invasive vs. Conventional Extracorporeal Circulation","Oxidative Stress and Systemic Inflammatory Response After Cardiac Surgery: Minimally Invasive Extracorporeal Circulation vs. Conventional Extracorporeal Circulation","Inclusion Criteria:\n\n* Patients undergoing elective isolated coronary artery bypass grafting (CABG) with the use of cardio-pulmonary bypass (CPB) through median sternotomy with central cannulation\n\nExclusion Criteria Before Enrollment:\n\n* refusal to participate in the study,\n* pregnant women,\n* patients with previous cardiac surgery (i.e., redo surgery),\n* emergency surgery,\n* patients with known allergy to any drugs used in the study protocol except cefazolin.\n\nExclusion Criteria After Enrollment:\n\n\\- Patients in whom intraoperative transesophageal echocardiogram (TEE) would show an atrial septal defect, where additional procedures would be needed intraoperatively or a conversion from MiECC to conventional extracorporeal circulation would be needed.","99 Years",{"count":342,"type":20},200,[318],"The goal of our research project is to measure and compare oxidative stress markers, and systemic inflammatory response in patients undergoing open heart surgery with either conventional or minimally invasive extracorporeal circulation as well as develop pharmacokinetic profiles of different oxidative stress markers for further research on inflammatory response after open heart surgery. The main questions our study aims to answer are :\n\n* Does the type of extracorporeal circulation affect the levels of different oxidative stress markers?\n* Can preoperative and postoperative oxidative stress marker levels be of prognostic values?\n* Do preoperative and postoperative oxidative stress markers correlate with the clinical outcomes in patients?\n\nResearchers will compare the effect of conventional and minimally invasive extracorporeal circulation on clinical outcomes, oxidative stress marker levels, and systemic inflammatory response.\n\nParticipants will be randomised into two groups (one undergoing arrested-heart surgery with the use of conventional extracorporeal circulation, and the second group undergoing arrested-heart surgery with the use of minimally invasive extracorporeal circulation) and laboratory data, oxidative stress markers, and clinical data will be collected until discharge.",[346,31,347],"Oxidative Stress","Extracorporeal Circulation; Complications",[349,350,351,346,31,352,353,354],"Cardiac Surgery","Minimally invasive extracorporeal circulation","Cardiopulmonary bypass","Oxidative stress biomarkers","Malondialdehyde","Endocan","2024-06-25",{"date":357,"type":54},"2024-06-27",{"date":359,"type":20},"2024-07-29",{"date":361,"type":20},"2026-12-31",{"name":363,"class":98},"University Medical Centre Maribor",{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":371,"enrollmentInfo":372,"targetDuration":4,"studyType":21,"phases":374,"briefSummary":376,"conditions":377,"keywords":384,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":176},"100452533","phase-4-opioid-free-anaesthesia-analgesia-strategy-on-surgical-stress-and-immunomodulation-in-elective-vats-lobectomy-for-nsclc-100452533","NCT05172739","Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC","Effect of a Perioperative Opioid Free Anaesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response and Immunomodulation in Elective VATS Lobectomy for NSCLC Lung Cancer: A Prospective Randomized Study","Inclusion Criteria:\n\n* patients undergoing elective VATS lobectomy\n* early stage NSCLC (up to T3N1M0)\n\nExclusion Criteria:\n\n* Immunocompromised patients\n* previous lung surgery\n* preoperative corticosteroid or immunosuppressive drug use\n* uncontrolled Diabetes Mellitus\n* cardiac failure (NYHA 3 and 4)\n* preoperative infection (CRP \\>5mg\u002Fml, WBC \\>10x10\\^9\u002FL)\n* preoperative anemia (Hb\\\u003C12g\u002Fdl)\n* chronic inflammatory diseases\n* inflammatory bowel disease\n\nGroup-specific exclusion criteria:\n\n* OFA-Α: perioperative opioid administration, within the study period\n* OBA-Α: perioperative dexmedetomidine or lidocaine infusion, ketamine, gabapentinoid or corticosteroid administration within the study period","80 Years",{"count":373,"type":20},70,[375],"PHASE4","Lobectomy is a major, high-risk surgical procedure that in addition to one-lung ventilation (OLV) exerts a potent surgical stress response. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis. The effect of anesthesia on the immune system is modest, compared to the effects induced by major surgery. However, to an immunocompromised patient, due to cancer and\u002For other comorbidities, the immunosuppressive effects of anesthesia may increase the incidence of post-operative infections, morbidity, and mortality. Exogenous opioids have been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes. An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic\u002Fanalgesic and other pharmacological agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects. Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, will lead to an attenuated surgical stress response and attenuated immunosuppression, compared to a conventional Opioid-Based Anaesthesia-Analgesia (OBA-A) strategy. The aforementioned effects, are presumed to be associated with equal or improved analgesia and decreased incidence of postoperative infections compared to a perioperative OBA-A technique.",[31,378,379,380,381,382,383],"Postoperative Pain, Acute","Postoperative Pain, Chronic","Infections Postoperative","Opioid Use","Anesthesia","Non-small Cell Lung Cancer",[385,386,387,388,389,390,391,392,393],"Opioid-free Anesthesia-Analgesia","Opioid-based Anesthesia-Analgesia","Cytokines","NSCLC","Hemodynamic stability","Immunomodulation","Inflammatory markers","Acute postoperative pain","Chronic postoperative pain","2021-12-10",{"date":396,"type":54},"2021-12-29",{"date":398,"type":54},"2021-10-01",{"date":400,"type":20},"2026-11-01",{"name":402,"class":98},"University of Crete"]