[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cytokine-storm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cytokine-storm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100623165","jafron-cytokine-adsorber-during-pediatric-open-heart-surgeries-100623165",false,"NCT07393087","Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries","JACKPOT","Inclusion Criteria:\n\n* Children ≤ 10 years old at study inclusion\n* Children weighing at least 5 kg at study inclusion\n* Planned for open-heart cardiac surgery with CPB-time ≥ 120 min and aortic clamping.\n* Informed consent obtained from parent(s)\u002Flegal representative\n\nExclusion Criteria:\n\n* Children having an indication to receive hemoadsorption during CPB for drugs removal or other medically justified reason\n* Previous enrolment into the current study\n* Off-pump procedure\n* Chronic immunosuppression (chronic corticosteroid therapy, chemotherapy, anti-leucocyte drugs, TNF blockers or else)\n* Known allergy to heparin or heparin induced thrombocytopenia.\n* Severe thrombopenia (platelets count before surgery \\\u003C 20G\u002FL)\n* Parent(s)\u002Flegal representative not able to understand\u002Fread French and\u002For English\n* Participation in another conflicting research study","ALL","10 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","This prospective single-center randomized controlled trial aims at evaluating the safety and feasibility of an hemoadsorption protocol using Jafron HA-60 during cardio-pulmonary bypass in 20 pediatric patients undergoing open-heart surgery.",[26,27,28,29,30],"Cardiac Surgery Recovery","Inflammation","Complex Cardiovascular Surgery With Cardiopulmonary Bypass","Cytokine Storm","Pediatric Open Heart Surgery",[32,33,34],"Feasibility pilot study","Pediatric open heart surgery","Hemoadsorption","NOT_YET_RECRUITING","2026-02-06",{"date":38,"type":39},"2026-02-10","ACTUAL",{"date":41,"type":20},"2026-03",{"date":43,"type":20},"2029-04",{"name":45,"class":46},"Centre Hospitalier Universitaire Vaudois","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100539829","phase-2-mrg-001-as-an-immunoregulatory-and-regenerative-therapy-for-ards-patients-100539829","NCT06308926","MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients","A Phase IIa, Double-Blind, Randomized, Multi-Center Study Comparing MRG-001 to Placebo in Patients With Acute Respiratory Distress Syndrome","SUMMIT","Inclusion Criteria:\n\nAcute Respiratory Distress Syndrome, manifested by the following and not explained by alternative diagnoses, for example but not limited to: Pulmonary Edema due to Congestive Heart Failure (CHF).\n\n1. Chest x-ray (CXR)\\* revealing bilateral infiltrates involving a minimum of three quadrants on frontal chest radiograph, consistent with pulmonary edema or bilateral ground glass opacities not fully explained by effusions, lobar or lung collapse, nodules, atelectasis or other etiology of infiltrates not due to ARDS.\n2. PaO2\u002FFiO2 \\\u003C 300.\n3. Requiring respiratory support \\[defined as mechanical ventilation, non-invasive ventilation (NIV) or high flow nasal canula (HFNC)\\] If on ventilator, settings must include positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥5 cm H2O.\n\nExclusion Criteria:\n\n1. Age less than 18 years.\n2. Infiltrates with etiology suspected of mimicking ARDS, ie; Pulmonary Edema due to Congestive Heart Failure (CHF). (A Pulmonary Arterial Wedge Pressure (PAWP) of \\\u003C 18 for \\>12 hours would rule out suspected CHF).\n3. Pregnancy documented or suspected in women of child bearing potential, unless ruled out by a negative pregnancy test during screening or breast feeding.\n4. Immunocompromised patients:\n\n   4.1. Organ or bone marrow transplant recipients and\u002For recent (within 2 months) chronic use of immunosuppressive drugs (tacrolimus, mycofenolate mofetil, cyclosporine, rapamycine, hydrochloroquine, azathiopurine, methotrexate), e.g., biologicals, JAK1\u002F2 inhibitors, interferons, interleukins, (prednisone or related corticosteroids are allowed).\n\n   4.2. Patients with documented or suspected HIV\u002FAIDS, hepatitis B\u002FC or active lung disease with tuberculosis. 4.3. Patients with active cancer diagnosis or use of chemotherapy in the past 3 months.\n5. Hypersensitivity to either of the components of MRG-001.\n6. The patient is known or suspected to be brain dead or is moribund (not expected to live \\>48 hours) or is unlikely to survive long enough to receive 3 injections (4 days) in the opinion of the investigator.\n7. The primary care physician is not committed to full support of the patient. (A DNR representing \"no chest compression\" only, would not necessarily be an exclusion. A DNR in which life support is withheld\u002Fwithdrawn or is otherwise limited, would be an exclusion).\n8. Participation in another investigational protocol or use of another investigational drug within 30 days of enrollment.\n9. Enrollment time window has been exceeded (must be enrolled within 7 days of hospital admission and within 48 hours of development of ARDS).\n10. Significant pre-existing organ dysfunction prior to randomization:\n\n    10.1. Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record. 10.2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \\\u003C20% as documented in the medical record. Clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3 months), significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure \\>180 mm Hg and diastolic blood pressure \\>110 mm Hg. WHO Class III or IV pulmonary hypertension. 10.3. Renal: End-stage renal disease requiring renal replacement therapy or eGFR \\\u003C30 mL\u002Fmin. 10.4. Liver: Severe chronic liver disease defined as Child-Pugh Class C or pre-existing severe hepatic dysfunction (i.e.; portal hypertension, cirrhosis, ascites, esophageal variceal bleeding, acute hepatic necrosis). 10.5. Hematologic: Baseline platelet count \\\u003C30,000\u002Fmm3 or hemoglobin levels \\\u003C6.0 g\u002FdL. 10.6. Neurological: Severe traumatic brain injury, with intracranial injury demonstrated by head CT 10.7. History of splenectomy or splenomegaly (spleen weighing \\> 750 g).\n11. Currently receiving extracorporeal life support (ECLS\u002FECMO) or high-frequency oscillatory ventilation (HFOV).\n12. Anticipated extubation within 24 hours of enrollment.","18 Years",{"count":58,"type":20},60,[60],"PHASE2","This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS.\n\nThe aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges.",[63,64,65,66,29],"Acute Respiratory Distress Syndrome","Respiratory Failure","Respiratory Distress Syndrome","Respiratory Tract Diseases",[63,68,69,70],"MRG-001","Stem Cells","Immunomodulation","2024-08-22",{"date":73,"type":39},"2024-08-23",{"date":75,"type":20},"2024-12-01",{"date":77,"type":20},"2026-07-01",{"name":79,"class":80},"MedRegen LLC","INDUSTRY",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":47},"100553890","clinical-outcomes-and-inflammatory-responses-in-viral-vs-bacterial-sepsis-100553890","NCT06491966","Clinical Outcomes and Inflammatory Responses in Viral vs. Bacterial Sepsis","Comparative Analysis of Clinical Outcomes and Inflammatory Responses in Viral Versus Bacterial Sepsis: A Retrospective Cohort Study in ICU Patients","Inclusion Criteria:\n\n1. Patients diagnosed with sepsis according to Sepsis 3.0 criteria.\n2. Patients with confirmed bacterial sepsis based on positive bacterial cultures.\n3. Patients with confirmed viral sepsis, specifically COVID-19, diagnosed via RT-PCR for SARS-CoV-2 for viral group and negative for bacterial group.\n4. Patients aged 18 years and older.\n5. Patients admitted to the ICU during the study period.\n\nExclusion Criteria:\n\n1. Patients with mixed bacterial and viral infections.\n2. Patients with sepsis not meeting the Sepsis 3.0 criteria.\n3. Patients who received immunomodulatory therapies other than standard treatments (e.g., investigational drugs).\n4. Pregnant or breastfeeding women.","90 Years",{"count":90,"type":20},300,"OBSERVATIONAL","This observational cohort study aims to compare clinical outcomes and inflammatory responses between patients with viral sepsis, specifically COVID-19-associated sepsis, and those with bacterial sepsis. Conducted at Sichuan Provincial People's Hospital, the study will retrospectively analyze data from ICU patients admitted between July 2021 and December 2023. The primary objective is to identify reliable biomarkers and diagnostic methods to improve patient outcomes through personalized diagnostic and therapeutic strategies.",[94,95,96,97,29,98,99],"Sepsis","Sepsis Bacterial","Viral Sepsis","Inflammatory Response","COVID-19","MODS","RECRUITING","2024-07-08",{"date":103,"type":39},"2024-07-09",{"date":105,"type":39},"2024-04-02",{"date":107,"type":20},"2024-07-10",{"name":109,"class":46},"Sichuan Provincial People's Hospital"]