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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitute of Liver and Biliary Sciences, India

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

Treatment groups

190 Participants
are divided into 2 treatment groups