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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver transplantation | |||
| Spontaneous survival | |||
| Death |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wan-Ting Zhang, MD | Contact | +86 13699189579 | 13699189579@163.com |
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| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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Biological specimens will be collected from participants for research purposes, including liver tissue, blood, urine, and stool samples.
| 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Every 48 hours from admission to discharge, assessed up to 30 days |