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

Recruiting

• Conditions: Liver Failure

• Registration Number: NCT05740696
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-06
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-22
• Last Update Submitted: 2023-02-22
• Study First Posted: 2023-02-23
• Last Update Posted: 2023-02-23
• Primary Completion: 2024-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	90-day	90-day survival rates without liver transplantation

Secondary Outcome Measures

Name	Time	Method
Disease progression	48 weeks after discharge	Incidence of complications and re-hospitalization at 48 weeks after discharge

Trial Locations

Locations (14)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Ankang Central Hospital; 🇨🇳 Ankang, China

Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

Hanzhong 3201 Hospital; 🇨🇳 Hanzhong, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, China

First Hospital of Lanzhou University; 🇨🇳 Lanzhou, China

Weinan Central Hospital; 🇨🇳 Weinan, China

Air Force Medical University Tangdu Hospital; 🇨🇳 Xi'an, China

Shaanxi provincial people's hospital; 🇨🇳 Xi'an, China

The Second Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, China

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