NCT Number: NCT07556055
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.
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Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
Time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)
Time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)
Time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3
Time frame: From enrollment to completion of biospecimen collection and etiologic multi-omics assessment, up to 7 days
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: 90 days after enrollment
Time frame: Up to 3 years after enrollment
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: Every 48 hours from admission to discharge, assessed up to 30 days
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Serial serum complement C4 measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Contact information is provided by the study sponsor or research team.
Li-Ying Sun
Other
A Bidirectional Cohort Study on the Etiology and Prognostic Factors of Acute Liver Failure and Development of a Dynamic Prediction Model
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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