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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

HCC

NCPF/EHPVO

Pregnancy

Post-Liver transplant

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention

    Other intervention

    No Intervention

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Chronic Liver Disease (CLD) With Hepatic Predominant Organ Failure1 intervention
Group B: Chronic Liver Disease (CLD) With Extra-hepatic Predominant Organ Failure1 intervention

Trial outcomes

Primary outcomes

1

Death or liver transplant at 6 months follow up.

Time frame
6 months

Secondary outcomes

1

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

Time frame
6 months
2

Organ dysfunction and organ failures

Time frame
day 28, day 90, day 180

Other outcomes

Sponsors and contacts

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