NCT07556055
尚未招募
不适用
A Bidirectional Cohort Study on the Etiology and Prognostic Factors of Acute Liver Failure and Development of a Dynamic Prediction Model
Li-Ying Sun0 个研究点目标入组 400 人开始时间: 2026年3月30日最近更新:
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Li-Ying Sun
- 入组人数
- 400
- 主要终点
- Overall Survival
概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Spontaneous survival
Death
Liver transplantation
结局指标
主要结局
Overall Survival
时间窗: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)
Transplant-Free Survival
时间窗: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)
Liver Transplantation Rate
时间窗: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3
次要结局
- 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)
- Change in total bilirubin over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in international normalized ratio (INR) over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in prothrombin time (PT) over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in serum creatinine over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in C-reactive protein (CRP) over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in direct bilirubin over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in prothrombin activity (PTA) over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in blood ammonia over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in blood phosphorus over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in white blood cell count (WBC) over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in red blood cell count (RBC) over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in hemoglobin (HGB) over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in platelet count (PLT) over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in D-dimer over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in serum albumin over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in arterial lactate over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in blood glucose over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in arterial pH over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in CD4+ T-cell count over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in CD8+ T-cell count over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in CD19+ B-cell count over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in CD56+ natural killer cell count over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in CD4+/CD8+ ratio over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in immunoglobulin M (IgM) over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in immunoglobulin G (IgG) over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in immunoglobulin A (IgA) over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in complement C3 over time(Every 48 hours from admission to discharge, assessed up to 30 days)
- Change in complement C4 over time(Every 48 hours from admission to discharge, assessed up to 30 days)
研究者
Li-Ying Sun
Director of Department of Critical Liver Diseases
Beijing Friendship Hospital
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