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.
Study Type
OBSERVATIONAL
Enrollment
400
Overall Survival
Time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)
Transplant-Free Survival
Time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)
Liver Transplantation Rate
Time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3
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 days
Short-Term Mortality
Time frame: 90 days after enrollment
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 enrollment
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 days
Change in aspartate aminotransferase (AST) over time
Serial serum AST 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 days
Change in total bilirubin over time
Serial total bilirubin 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 days
Change in international normalized ratio (INR) over time
Serial INR 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 days
Change in prothrombin time (PT) over time
Serial PT 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 days
Change in serum creatinine over time
Serial serum creatinine 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 days
Change in C-reactive protein (CRP) over time
Serial serum C-reactive protein 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 days
Change in direct bilirubin over time
Serial direct bilirubin 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 days
Change in prothrombin activity (PTA) over time
Serial prothrombin activity (PTA) 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 days
Change in blood ammonia over time
Serial blood ammonia 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 days
Change in blood phosphorus over time
Serial blood phosphorus 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 days
Change in white blood cell count (WBC) over time
Serial white blood cell count (WBC) 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 days
Change in red blood cell count (RBC) over time
Serial red blood cell count (RBC) 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 days
Change in hemoglobin (HGB) over time
Serial hemoglobin (HGB) 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 days
Change in platelet count (PLT) over time
Serial platelet count (PLT) 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 days
Change in D-dimer over time
Serial D-dimer 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 days
Change in serum albumin over time
Serial serum albumin 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 days
Change in arterial lactate over time
Serial arterial lactate 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 days
Change in blood glucose over time
Serial blood glucose 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 days
Change in arterial pH over time
Serial arterial pH 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 days
Change in CD4+ T-cell count over time
Serial CD4+ T-cell count 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 days
Change in CD8+ T-cell count over time
Serial CD8+ T-cell count 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 days
Change in CD19+ B-cell count over time
Serial CD19+ B-cell count 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 days
Change in CD56+ natural killer cell count over time
Serial CD56+ natural killer cell count 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 days
Change in CD4+/CD8+ ratio over time
Serial CD4+/CD8+ ratio 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 days
Change in immunoglobulin M (IgM) over time
Serial serum immunoglobulin M (IgM) 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 days
Change in immunoglobulin G (IgG) over time
Serial serum immunoglobulin G (IgG) 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 days
Change in immunoglobulin A (IgA) over time
Serial serum immunoglobulin A (IgA) 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 days
Change in complement C3 over time
Serial serum complement C3 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 days
Change in complement C4 over time
Serial serum complement C4 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 days
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