To Study the Clinical Course and Outcomes of Non-electively Hospitalised Patients of Chronic Liver Disease (CLD) With Hepatic or Extra-hepatic Predominant Organ Failure(s) at 6 Months.

November 26, 2025 updated by: Institute of Liver and Biliary Sciences, India

Title - To study the clinical course and outcomes of non-electively hospitalised patients of chronic liver disease (CLD) with Hepatic or Extra-hepatic predominant organ failure(s) at 6 months.

Summary - ACLF is a condition where acute insult leading to worsening liver failure with or without extra-hepatic failure leads to a high short-term mortality. However, the presence of cirrhosis, prior decompensation, non-hepatic/systemic acute insult, organ failure and treatment are different in different part of the world. This is due to in-homogenous patient cohort. The current study was planned for all patients of CLD, who were non-electively hospitalized and were followed up for long-term to identify the differences in clinical course, acute insult, organ failure, therapy and outcome in relation to liver failure with or without extra-hepatic organic failure. In the study the laboratory, clinical parameters, inflammatory and regenerative markers will be evaluated as a marker of disease progression, reversal, recompensation or regression. This will enable us to differentiate the ACLF between east and west, guide us for defining the natural course of CLD with failure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110070
        • Institute of Liver & Biliary Sciences (ILBS)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chronic Liver Disease with or without cirrhosis, non-electively hospitalized with decompensation, hepatic and/or extra-hepatic organ failure with/without prior decompensation.

Description

Inclusion Criteria:

  1. Age 18-70 years
  2. CLD with or without cirrhosis with 1st or subsequent admissions for decompenasation and irrespective of any prior decompensation
  3. Non-electively hospitalized

Exclusion Criteria:

  1. HCC
  2. NCPF/EHPVO
  3. Pregnancy
  4. Post-Liver transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic Liver Disease (CLD) With Hepatic Predominant Organ Failure
Other: No Intervention
No Intervention
Chronic Liver Disease (CLD) With Extra-hepatic Predominant Organ Failure
Other: No Intervention
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death or liver transplant at 6 months follow up.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Recovery as per disease severity scores, i.e- decrease in MELD ≥5 and CTP ≥3
Time Frame: 6 months
6 months
Organ dysfunction and organ failures
Time Frame: day 28, day 90, day 180
day 28, day 90, day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ILBS-CLD-66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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