protocolSection identificationModule nctId: NCT06276907, orgStudyIdInfo id: ILBS-ACLF-16, briefTitle: 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Institute of Liver and Biliary Sciences, India, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Acute on Chronic Liver Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 190, type: ESTIMATED, armsInterventionsModule interventions name: Plasma Exchange, interventions name: Standard Medical Treatment, outcomesModule primaryOutcomes measure: The AARC grading is done by AARC score the values of which vary from 5-15, pts are divided into 3 grades i.e AARC score 5-7- grade 1, 8-10- grade 2, and AARC 11-15 as grade 3. Improvement in 1 grade is associated with 40% improvement in 28-day survival, secondaryOutcomes measure: Transplant-free survival at 28-days, secondaryOutcomes measure: The impact of TPE on the progression or resolution of secondary organ failures at day 7, 14 and 28, secondaryOutcomes measure: the development of infection at day 7 and 14 in patients who had no infection, secondaryOutcomes measure: Duration of ICU and hospital stay, secondaryOutcomes measure: The proportion of patients developing adverse events will be compared between the two groups, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Liver & Biliary Sciences, city: New Delhi, state: Delhi, zip: 110070, country: India, contacts name: Dr Rakhi Maiwall, DM, role: CONTACT, phone: 01146300000, email: rakhi_2011@yahoo.co.in, geoPoint lat: 28.63576, lon: 77.22445, hasResults: False