Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)

NCT07178366 | Not Yet Recruiting

• 2 other identifiers: IEC/2025/117/MA01IEC Approval Number
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute-on-Chronic Liver Failure (ACLF)

Keywords

ACLF; DPMAS; Lactate; Sepsis; Liver support

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (12)

• Transplant-free survival

  28 Days

• Change in cytokine levels

  14 days

• Change in DAMPs

  14 days

• Change in serum bilirubin levels

  14 days

• Change in serum bile acid levels

  14 days

Study Arms (2)

Standard Medical Therapy (SMT) Group

ACTIVE COMPARATOR

Participants will receive standard medical therapy alone, which may include nutritional support, lactulose, bowel wash, albumin, vasopressors (norepinephrine/terlipressin), antibiotics, antivirals for HBV reactivation, renal replacement therapy, and intensive care support as per institutional guidelines.

Other: Standard medical therapy (SMT)

SMT + Double Plasma Molecular Adsorption System (DPMAS)

EXPERIMENTAL

Participants will receive standard medical therapy plus DPMAS therapy. DPMAS involves extracorporeal liver support using two sequential hemoadsorption cartridges (BS330 ion exchange resin and HA330-II neutral macroporous adsorption resin). A minimum of 2 sessions (3-4 hours each) will be given in the first 7 days, with additional sessions if partial response is observed.

Other: Standard medical therapy (SMT); Device: Double Plasma Molecular Adsorption System (DPMAS)

Interventions

Double Plasma Molecular Adsorption System (DPMAS) DEVICE

DPMAS 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.

SMT + Double Plasma Molecular Adsorption System (DPMAS)

Standard medical therapy (SMT) OTHER

Standard 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.

SMT + Double Plasma Molecular Adsorption System (DPMAS); Standard Medical Therapy (SMT) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ACLF patients of any etiology with systemic inflammatory response syndrome and AARC grade II or more.

You may not qualify if:

• 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
• Hemodynamic instability requiring norepinephrine \>0.20ug/kg/min
• Patients with coma of non-hepatic origin
• Patients with PaO2/FiO2 ratio \<150
• Pregnancy
• Comorbidities associated with poor outcomes (severe cardiopulmonary disease defined by a New York Heart Association score \>3, or oxygen/steroid-dependent chronic obstructive pulmonary disease, chronic kidney disease) and patients with post-resection liver failure
• Patients with fibrinogen \<110 and/or platelets less than 50,000
• Patients with oliguria with urine output less than 400 ml/day
• Lack of informed consent
• Patient enrolled in other clinical trials

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Sepsis

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr. Rakhi Maiwall, MBBS, MD, DM

CONTACT

+91 8750343085; rakhi_2011@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label randomized controlled trial. No masking will be performed for participants, care providers, investigators, or outcomes assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of hepatology

Model Details: Participants will be randomized in a 1:1 ratio into two parallel groups. One group will receive standard medical therapy (SMT) alone, while the other group will receive SMT plus Double Plasma Molecular Adsorption System (DPMAS). Randomization will be open-label, and each participant will remain in the assigned group for the duration of the study.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 17, 2025
• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03