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.

NCT ID: NCT07270809

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic Liver Disease (CLD) With Hepatic Predominant Organ Failure

No Intervention

Intervention Type OTHER

No Intervention

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

No Intervention

Intervention Type OTHER

No Intervention

Interventions

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No Intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Central Contacts

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Dr Amanjot Kaur, MD

Role: CONTACT

01146300000

Dr Ashok Chaoudhury, DM

Role: CONTACT

01146300000

Facility Contacts

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Dr Amanjot Kaur, MD

Role: primary

01146300000

Other Identifiers

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ILBS-CLD-66

Identifier Type: -

Identifier Source: org_study_id

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