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

Sponsored by Institute of Liver and Biliary Sciences, India

About this trial

Last updated 2 months ago

Study ID

IEC/2025/117/MA01

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Started 13 days ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

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

Exclusion Criteria

* 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