[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537367":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":27,"locations":33,"responsibleParty":49,"collaborators":24,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":24,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":24,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":24,"overallStatus":69,"whyStopped":24,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Plasma Exchange","EXPERIMENTAL","On day 1 Response assessment will be done to assess the need for a second session from day 3-7 and subsequently every week till day 28. A minimum of 3 sessions would be considered in the first seven days. The duration of each session would be 3-4 hours. Patients with partial response (not meeting criteria for a complete response after 3 sessions) would be considered for additional sessions as decided by the treating physician until desired complete response, adverse effects, liver transplant, death, or clinical futility. The complete response will be defined as a sustained reduction in bilirubin and international normalized ratio without any clinical worsening requiring discontinuation of therapy. Failure of therapy would be defined as the development of adverse effects, new onset sepsis, or organ failure. In such patients, further sessions would be deferred. Blood access was established with a double-lumen catheter inserted into the patient's femoral or jugular vein.",[13],"Biological: Plasma Exchange",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Medical Treatment","ACTIVE_COMPARATOR","Patients randomized to SMT Group will be given standard medical therapy (SMT) only included as per requirement.",[19],"Other: Standard Medical Treatment",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL",[9],null,{"type":6,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":24,"email":32},"Dr Rakhi Maiwall, DM","CONTACT","01146300000","rakhi_2011@yahoo.co.in",[34],{"facility":35,"status":24,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Institute of Liver & Biliary Sciences","New Delhi","National Capital Territory of Delhi","110070","India","IN",{"type":42,"coordinates":43},"Point",[44,45],77.2148,28.62137,{"lat":45,"lon":44},[48],{"name":29,"role":30,"phone":31,"phoneExt":24,"email":32},{"type":50,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100537367","an-open-label-randomized-controlled-trial-comparing-the-role-of-therapeutic-plasma-exchange-in-ameliorating-secondary-organ-dysfunctions-in-patients-with-aclf-and-develop-biomarkers-of-treatment-response-100537367",false,"NCT06276907","An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Organ Dysfunctions in Patients With ACLF and Develop Biomarkers of Treatment Response","Inclusion Criteria:\n\n1. Patients with ACLF with AARC grade 2 or more with or without single secondary organ failure.\n\nExclusion Criteria:\n\n1. 1\\. Patients with age less than 18 years or more than 65 years\n2. Patients with HVOTO or EHPVO\n3. Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy\n4. Active bleed (mucosal or variceal) or severe coagulopathy (platelets \\\u003C20,000 or INR\\>4)\n5. Patients with refractory shock requiring norepinephrine \\>0.5ug\u002Fkg\u002Fmin\n6. Patients with retroviral infections\n7. Pregnancy or active breastfeeding\n8. Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease)\n9. Lack of informed consent","ALL","18 Years","65 Years",{"count":61,"type":62},190,"ESTIMATED","INTERVENTIONAL",[65],"NA","Rationale: Current understanding of the pathophysiology of ACLF suggests that unresolved injury, poor infection control, and liver regeneration result in persistent systemic inflammation and cytokine storm, which subsequently lead to systemic inflammatory response syndrome (SIRS) resulting in multiple organ failures, septic shock and deaths in ACLF. Nearly 74% of ACLF patients initially diagnosed without SIRS, sepsis, or organ failure developed SIRS by day 7 which increases the onset of secondary organ failure and sepsis with high short-term mortality. The emerging use of plasma exchange has shown some potential benefits in terms of dampening systemic inflammation and improvement of outcomes in some ACLF patients. However, there is currently no randomized controlled trial exploring the potential role in ameliorating secondary organ dysfunctions in patients with ACLF is not known. Hence in the current objective, we want to study the role of plasma exchange in the management of sec. organ failure in ACLF patients in a randomized controlled trial and identify the biomarker to access the treatment response to therapy.",[68],"Acute on Chronic Liver Failure","NOT_YET_RECRUITING","2024-02-23",{"date":72,"type":73},"2024-02-26","ACTUAL",{"date":75,"type":62},"2024-03-01",{"date":77,"type":62},"2027-12-31",{"name":5,"class":6},1]