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

Liver Failure Clinical Trial

— RESOLVE-C  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05740696
• Other study ID #: XJTU1AF2023LSK-019
• Status: Recruiting
• Start date: January 6, 2023
• Est. completion date: December 30, 2028

Study information

• Verified date: January 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yingli He, Pro.
• Phone: 0086-18991232863
• Email: heyingli2000[@]xjtu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2028
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure

Intervention

Procedure:
• ALF
Acute onset, no history of underlying liver disease, liver failure characterized by degree ? or above hepatic encephalopathy developed within 2 weeks
• SALF
The onset was acute, with no history of underlying liver disease, and clinical manifestations of liver failure appeared between 2 and 26 weeks
• ACLF
On the basis of chronic liver disease, the clinical manifestations of acute liver decompensation and liver failure appear in a short period

Locations

Country	Name	City	State
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	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Shaanxi provincial people's hospital	Xi'an
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	Xi 'an International Medical Center Hospital	Xi'an
China	Xianyang Central Hospital	Xianyang
China	The Affiliated Hospital of Yan'an University	Yanan
China	General Hospital of Ningxia Medical University	Yinchuan

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	28-day survival rates without liver transplantation	28-day
Primary	Overall survival	90-day survival rates without liver transplantation	90-day
Secondary	Disease progression	Incidence of complications and re-hospitalization at 48 weeks after discharge	48 weeks after discharge