Etiology and Prognostic Factors in Patients With Acute Liver Failure
ConditionAcute Liver Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLi-Ying Sun
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients (or guardians) who provide informed consent
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 3 trial groupsGroup A: Liver transplantation
Group B: Spontaneous survival
Group C: Death
Trial outcomes
Primary outcomes
1
Overall Survival
Time frame
Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)2
Transplant-Free Survival
Time frame
Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)3
Liver Transplantation Rate
Time frame
Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3Secondary outcomes
1
Etiologic features identified by multi-omics analysis
Etiologic features in participants with acute liver failure will be assessed through multi-omics analyses of biospecimens, including liver tissue obtained from resected diseased liver during surgery (approximately 3 cm³) or from one ultrasound-guided liver biopsy core (approximately 2 cm in length), together with blood, urine, and stool samples. Multi-omics testing includes transcriptomic sequencing, proteomic analysis, metabolomic analysis, and metagenomic sequencing.
Time frame
From enrollment to completion of biospecimen collection and etiologic multi-omics assessment, up to 7 days2
Short-Term Mortality
Time frame
90 days after enrollment3
Development of Prognostic Prediction Model
A prognostic model will be developed using clinical variables, laboratory parameters, and dynamic changes over time. Multivariable logistic regression and receiver operating characteristic (ROC) curve analysis will be used to evaluate model performance, including discrimination and calibration.
Time frame
Up to 3 years after enrollment4
Change in alanine aminotransferase (ALT) over time
Serial serum ALT measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Time frame
Every 48 hours from admission to discharge, assessed up to 30 daysLocations
Sponsors and contacts
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Li-Ying Sun
Lead sponsor
Beijing Friendship Hospital
Sponsor institution
Source ClinicalTrials.gov
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