Acute-on-chronic liver failure (ACLF) is a serious condition in which patients with chronic liver disease suddenly develop severe liver injury, leading to inflammation, organ failure, and very high short-term mortality. Standard medical treatment can help, but many patients still do poorly without liver transplantation.
This study will test whether Double Plasma Molecular Adsorption System (DPMAS), an extracorporeal blood purification therapy, can improve outcomes in ACLF patients. DPMAS works by filtering the blood through special adsorption columns that remove harmful substances such as bile acids, toxins, and inflammatory molecules.
In this randomized controlled trial, adult patients with ACLF will be randomly assigned to receive either:
Standard medical therapy alone, or
Standard medical therapy plus DPMAS.
The main goal is to see whether DPMAS can improve liver function and reduce disease severity within 14 days. Other outcomes include survival without liver transplant at 28 days, improvement in organ functions, reduction in inflammation, and safety of the procedure.
The study will be conducted at the Institute of Liver and Biliary Sciences (ILBS), New Delhi, India, and will enroll about 56 participants over one year.
ACLF patients of any etiology with systemic inflammatory response syndrome and AARC grade II or more.
Patients eligible for corticosteroids for severe alcohol-associated hepatitis related ACLF (other than hydrocortisone according to Surviving Sepsis Campaign Guidelines 2021 which is 50 mg iv q 6 h for management of refractory shock
Hepatocellular carcinoma or any extrahepatic malignancy,
Active fungal sepsis
Disseminated intravascular coagulation
Parallel
Standard medical therapy (SMT)
Other interventionStandard medical therapy includes nutritional support (25-30 kcal/kg/day), lactulose, bowel wash, albumin, vasopressors (norepinephrine/terlipressin), antibiotics, antivirals for HBV reactivation, renal replacement therapy, and intensive care support as per institutional guidelines.
Double Plasma Molecular Adsorption System (DPMAS)
DeviceDPMAS therapy uses extracorporeal liver support with two sequential hemoadsorption cartridges (BS330 ion exchange resin and HA330-II neutral macroporous adsorption resin). Minimum 2 sessions (3-4 hours each) are performed within the first 7 days, with additional sessions if partial response is observed.
Improvement in AARC ACLF grade by one at day 14 (after 7 days off treatment)
Proportion of participants who show an improvement of at least one grade in the Asian Pacific Association for the Study of the Liver acute-on-chronic liver failure (AARC ACLF) score at day 14, assessed after a treatment-free interval of 7 days from randomisation.
Transplant-free survival
Proportion of participants alive without liver transplantation at 28 days after randomization.
Change in cytokine levels
Change in serum cytokine concentrations (IL-6, TNF-α, IL-10) measured by multiplex bead-based immunoassay (e.g., Luminex platform) from baseline to Day 14
Change in DAMPs
Change in circulating damage-associated molecular patterns (HMGB1 and mitochondrial DNA) measured by ELISA and quantitative PCR, respectively, from baseline to Day 14
Change in serum bilirubin levels
Change in serum bilirubin concentration from baseline to Day 14.
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This trial is not recruiting at the moment. You can still explore other options:
