Registry Study for Optimal Management of Liver Failure in the Chinese Population

Study Overview
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Brief Summary
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Liver failure is the most severe form of liver damage caused by viral, alcoholic, drug-related and ischemia-reperfusion factors, often combined with extrahepatic organ damage, resulting in a high mortality rate. This study intends to construct a real-world case registry database of inpatients with liver failure based on an electronic clinical data collection system through a multicenter collaborative network to study the clinical characteristics, epidemiology of bacterial and fungal infections, the impact of sarcopenia on clinical prognosis, and optimization of treatment strategies such as antiviral and artificial liver in Chinese inpatients with liver failure. The cohort and experience generated from this study will be used as a support for a series of future studies to focus on clinical issues such as infection, end-stage liver disease combined with organ failure, and early warning of critically ill patients.

Official Title
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Registry Study for Optimal Management of Liver Failure in the Chinese Population (RESOLVE-C)

Conditions
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Liver Failure

Intervention / Treatment
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* Procedure: ALF
* Procedure: SALF
* Procedure: ACLF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis consistent with liver failure and pre-liver failure: Extreme weakness with significant gastrointestinal symptoms such as anorexia, vomiting and abdominal distention; Elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) with progressive jaundice (TBil≥85.5 μmol/L); Bleeding tendency with PTA ≤ 60% or INR ≥ 1.5. Exclusion Criteria: An event or complication that, in the judgment of the investigator, significantly affects the assessment of clinical status.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALF<br>acute liver failure | Procedure: ALF<br>* Acute onset, no history of underlying liver disease, liver failure characterized by degree Ⅱ or above hepatic encephalopathy developed within 2 weeks<br>|
| SALF<br>subacute liver failure | Procedure: SALF<br>* The onset was acute, with no history of underlying liver disease, and clinical manifestations of liver failure appeared between 2 and 26 weeks<br>|
| ACLF<br>acute-on-chronic liver failure | Procedure: ACLF<br>* On the basis of chronic liver disease, the clinical manifestations of acute liver decompensation and liver failure appear in a short period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 28-day survival rates without liver transplantation | 28-day | 
| Overall survival | 90-day survival rates without liver transplantation | 90-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression | Incidence of complications and re-hospitalization at 48 weeks after discharge | 48 weeks after discharge |