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.

NCT07270809 | Not Yet Recruiting

• 1 other identifier: ILBS-CLD-66
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• Death or liver transplant at 6 months follow up.

  6 months

Secondary Outcomes (2)

• Recovery as per disease severity scores, i.e- decrease in MELD ≥5 and CTP ≥3

  6 months

• Organ dysfunction and organ failures

  day 28, day 90, day 180

Study Arms (2)

Chronic Liver Disease (CLD) With Hepatic Predominant Organ Failure

Other: No Intervention

Chronic Liver Disease (CLD) With Extra-hepatic Predominant Organ Failure

Other: No Intervention

Interventions

No Intervention OTHER

No Intervention

Chronic Liver Disease (CLD) With Extra-hepatic Predominant Organ Failure; Chronic Liver Disease (CLD) With Hepatic Predominant Organ Failure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• HCC
• NCPF/EHPVO
• Pregnancy
• Post-Liver transplant

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Central Study Contacts

Dr Amanjot Kaur, MD

CONTACT

01146300000; amanjotbahri@gmail.com

Dr Ashok Chaoudhury, DM

CONTACT

01146300000; doctor.ashokchoudhury@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: December 8, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

IN (1)