Etiology and Prognostic Factors in Patients With Acute Liver Failure

NCT07556055 | Not Yet Recruiting

• 1 other identifier: BFHHZS20260102
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute liver failure (ALF) is a rare but life-threatening condition with high mortality. Despite advances in supportive care and liver transplantation, prognosis varies significantly across etiologies, particularly in patients with indeterminate causes. This study aims to investigate the dynamic changes of clinical and biochemical indicators, identify potential etiologies-especially in indeterminate ALF-and evaluate prognostic risk factors. A dynamic prediction model will be developed to optimize clinical decision-making, including liver transplantation timing. Both retrospective and prospective cohorts will be included. Multi-omics analyses (including transcriptomics, proteomics, metabolomics, and metagenomic sequencing) will be performed on liver tissue and biological samples to explore disease mechanisms and etiology.

Conditions

Acute Liver Failure

Outcome Measures

Primary Outcomes (3)

• Overall Survival

  Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)

• Transplant-Free Survival

  Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)

• Liver Transplantation Rate

  Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3

Secondary Outcomes (33)

• Etiologic features identified by multi-omics analysis

  From enrollment to completion of biospecimen collection and etiologic multi-omics assessment, up to 7 days

• Short-Term Mortality

  90 days after enrollment

• Development of Prognostic Prediction Model

  Up to 3 years after enrollment

• Change in alanine aminotransferase (ALT) over time

  Every 48 hours from admission to discharge, assessed up to 30 days

• Change in aspartate aminotransferase (AST) over time

  Every 48 hours from admission to discharge, assessed up to 30 days

Study Arms (3)

Liver transplantation

Spontaneous survival

Death

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients diagnosed with acute liver failure who are treated at Beijing Friendship Hospital, Capital Medical University. Both adult and pediatric patients meeting established diagnostic criteria for acute liver failure will be included. The study includes two cohorts: a retrospective cohort of patients treated between November 2016 and February 2026, and a prospective cohort of newly diagnosed patients enrolled from March 2026 onward. Patients will be followed longitudinally to evaluate clinical outcomes, including survival, liver transplantation, and transplant-free survival.

You may qualify if:

• Patients meeting diagnostic criteria for acute liver failure:
• Adults: Acute onset without pre-existing liver disease, development of hepatic encephalopathy ≥ grade II within 4 weeks Pediatrics: Acute onset (\<26 weeks), no chronic liver disease, coagulopathy not corrected by vitamin K: INR ≥1.5 with encephalopathy OR; INR \>2 regardless of encephalopathy
• Patients (or guardians) who provide informed consent

You may not qualify if:

• Presence of end-stage extrahepatic disease without effective treatment
• Pregnant or breastfeeding women
• Inability or unwillingness to provide informed consent or comply with study procedures

Sponsors & Collaborators

• Li-Ying Sun: lead

Biospecimen

Retention: SAMPLES WITH DNA

Biological specimens will be collected from participants for research purposes, including liver tissue, blood, urine, and stool samples.

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wan-Ting Zhang, MD

CONTACT

+86 13699189579; 13699189579@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department of Critical Liver Diseases

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 29, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 31, 2036
• Study Completion (Estimated): December 31, 2037
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share