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
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.
- EligibilityCriteria: Inclusion Criteria:  Patients with ACLF with AARC grade 2 or more with or without single secondary organ failure.  Exclusion Criteria:  1. Patients with age less than 18 years or more than 65 years Patients with HVOTO or EHPVO Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy Active bleed (mucosal or variceal) or severe coagulopathy (platelets <20,000 or INR>4) Patients with refractory shock requiring norepinephrine >0.5ug/kg/min Patients with retroviral infections Pregnancy or active breastfeeding Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease) Lack of informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult