Standard-Volume Plasma Exchange Improves Outcomes in Patients With Acute Liver Failure: A Randomized Controlled Trial.
Maiwall, Rakhi *; Bajpai, Meenu ++; Singh, Akanksha *; Agarwal, Tanvi [S]; Kumar, Guresh [//]; Bharadwaj, Ankit [//]; Nautiyal, Nidhi [S]; Tevethia, Harsh *; Jagdish, Rakesh Kumar *; Vijayaraghavan, Rajan *; Choudhury, Ashok *; Mathur, Rajendra Prasad [P]; Hidam, Ashini [S]; Pati, Nirupama Trehan [S]; Sharma, Manoj Kumar *; Kumar, Anupam [S]; Sarin, Shiv Kumar *,*
[Article]
Clinical Gastroenterology & Hepatology.
20(4):e831-e854, April 2022.
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BACKGROUND: High volume plasma-exchange (HVPE) improves survival in patients with acute liver failure (ALF), but apprehension regarding volume overload and worsening of cerebral edema remain.
METHODS: In an open-label randomized controlled trial, 40 consecutive patients of ALF were randomized 1:1 to either standard medical treatment (SMT) or SMT with standard-volume plasma-exchange (SVPE). SVPE was performed using centrifugal apheresis [target volume of 1.5 to 2.0 plasma volumes per session] until desired response was achieved. Cerebral edema was assessed by brain imaging. Results were analyzed in an intention-to-treat analysis. Primary outcome was 21-day transplant-free survival. The levels of cytokines, damage-associated molecular patterns (DAMPs) and endotoxins were analyzed at baseline and day 5.
RESULTS: ALF patients [aged 31.5 /- 12.2 years, 60% male, 78% viral, 83% hyperacute, 70% with SIRS were included. At day 5, SVPE [mean sessions 2.15 /- 1.42, median plasma volume replaced 5.049 L] compared to SMT alone, resulted in higher lactate clearance (p = .02), amelioration of SIRS (84% vs. 26%; P = .02), reduction in ammonia levels [(221.5 /- 96.9) vs.(439 /- 385.6) [mu]g/dl, P = .02) and SOFA scores [9.9( /-3.3) vs. 14.6( /-4.8); P = .001]. There were no treatment related deaths. SVPE was associated with a higher 21-day transplant free-survival [75% vs. 45%; P = .04, HR 0.30, 95%CI 0.01-0.88]. A significant decrease in levels of pro-inflammatory cytokines and an increase in anti-inflammatory cytokines along with a decrease in endotoxin and DAMPs was seen with SVPE.
CONCLUSION: In ALF patients with cerebral edema, SVPE is safe and effective and improves survival possibly by a reduction in cytokine storm and ammonia. ClinicalTrial.gov (identifier: NCT02718079)
(C) 2022Elsevier, Inc.
