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

NCT06387160 | Not Yet Recruiting

• 1 other identifier: ILBS-ACLF-18
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute-On-Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• 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]

  6 months

Secondary Outcomes (9)

• Change in Asian Pacific Association of Research consortium [AARC] Score from baseline to 90 days and 6 month follow up

  3 and 6 months

• 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

• 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 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

Study Arms (1)

ACLF

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

Drug: as per institutional protocol

Interventions

as per institutional protocol DRUG

This is an observational study. Treatment will be given to the patients as per institutional protocol

ACLF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and Biliary Sciences

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

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Central Study Contacts

Dr Shreyas Sarvesh, MD

CONTACT

01146300000; shreyassarvesh@gmail.com

Study Design

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

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 26, 2024
• Study Start: April 20, 2024
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-03

Locations

IN (1)