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.
Patients with ACLF with AARC grade 2 or more with or without single secondary organ failure.
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)
Parallel
Plasma Exchange
Biological/VaccineOn 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.
Standard Medical Treatment
Other interventionPatients randomized to SMT Group will be given standard medical therapy (SMT) only included as per requirement.
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
the measure is an ordinal variable with 3 categories as above (grade 1, 2 and 3) derived from AARC score from 5-15
Transplant-free survival at 28-days
The impact of TPE on the progression or resolution of secondary organ failures at day 7, 14 and 28
Each organ failure will be defined based on the definition as yes or no. Depending on if the patient improves or progresses the information will be collected and analyzed.
the development of infection at day 7 and 14 in patients who had no infection
Duration of ICU and hospital stay
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