About this trial
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.
Eligibility criteria
Qualifiers
Patients with ACLF with AARC grade 2 or more with or without single secondary organ failure.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Plasma Exchange
- Standard Medical Treatment