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Clinical Trials/NCT06387160
NCT06387160Not yet recruitingNot Applicable

To Determine the Predictors of Reversibility for Acute-on-Chronic Liver Failure at 6-months-A Prospective Study.

Institute of Liver and Biliary Sciences, India1 site in 1 country480 target enrollmentStarted: April 20, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
480
Locations
1
Primary Endpoint
To determine predictors of Reversibility[ Serum Bilirubin < 5mg/dl and PTINR <1.5] at 6 months in Patients of Acute on chronic liver failure as defined by Asian pacific association of study of liver disease[APASL]

Study Overview

Brief Summary

ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity <40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality .From the point of view of intensivists, events in form of organ dysfunction , failure or mortality would cumulatively effect the outcome.Reversibility of ACLF syndrome is a feature of the ACLF defined by the AARC criteria, as nearly all the patients included are after the index presentation.With mitigation of the acute insult and over time, the hepatic reserve improves ,fibrosis regresses and the portal pressure decreases. Further, unlike patients with decompensated cirrhosis and similar to patients with ALF, the reversal of coagulopathy preceded the reversal of jaundice,that is ,median time to reversal of syndrome, i.e jaundice and coagulopathy was 7 (4-30)days versus 19 (7-60)days for jaundice, respectively. The median time for reversal of syndrome, i.e, jaundice and coagulopathy ,was 30 days. Baseline albumin, AARC score and Transient elastography predicted long term reversibility .The disease severity assessment is needed for prognostication and to guide the therapy. Furthermore,the available prediction scores have been validated at baseline,but none has been evaluated in a dynamic manner for prognostication in ACLF patients.A DYNAMIC Model that could predict the reversibility in ACLF is urgently required.

Detailed Description

Hypothesis:Baseline factors could reliably predict reversibility of ACLF, will help in improved clinical outcomes and risk stratifications.

Aim: To identify the predictors based on clinical, biochemical parameters and noninvasive tests to reliably predict reversibility of ACLF at 6 months

Methodology:

Study population:

  • Age - 18-75 years
  • Patients with ACLF(as per APASL guidelines) Study design:Prospective Cohort study done at Department of Hepatology,Institute of Liver and Biliary Sciences,New Delhi,India. The study will be conducted in Department of Hepatology .

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age - 18-75 years
  • Patients with ACLF(as per APASL guidelines) admitted in department of Hepatology.
  • Acute Insult-Alcohol,HBV,Auto-immune hepatitis,Viral hepatitis,Drug Induced Liver Injury

Exclusion Criteria

  • Acute decompensation
  • Complete portal vein thrombosis
  • Hepatocellular carcinoma
  • Tumoral portal vein thrombosis
  • Chronic kidney disease
  • Failure to give consent

Arms & Interventions

ACLF

  1. Age - 18-75 years
  2. Patients with ACLF(as per APASL guidelines)

Intervention: as per institutional protocol (Drug)

Outcomes

Primary Outcomes

To determine predictors of Reversibility[ Serum Bilirubin < 5mg/dl and PTINR <1.5] at 6 months in Patients of Acute on chronic liver failure as defined by Asian pacific association of study of liver disease[APASL]

Time Frame: 6 months

Secondary Outcomes

  • Change in Asian Pacific Association of Research consortium [AARC] Score from baseline to 90 days and 6 month follow up(3 and 6 months)
  • Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 6months.(6 months)
  • Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 90 Days.(3 months)
  • Change in Spleen stiffness measurement [SSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months(28 days, 90-day and 6-months)
  • Change in Grade of fibrosis at Baseline [Day 0 to 28 Day of presentation] measured by Magnetic resonance elastography with 90 Days and 6months values(3 and 6 months)
  • Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving re compensation at 1year.(1 year)
  • Change in liver stiffness measurement [LSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months.(28 days, 90-day and 6-months)
  • Proportion of Acute on Chronic Liver failure patients maintaining reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 1year.(1 year)
  • Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving survival at 1year.(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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