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

February 22, 2023 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Ankang, China
        • Recruiting
        • Ankang Central Hospital
        • Contact:
          • Zicheng Jiang
      • Changsha, China
        • Not yet recruiting
        • Xiangya Hospital of Central South University
        • Contact:
          • Ruochan Chen
      • Hanzhong, China
        • Not yet recruiting
        • Hanzhong 3201 Hospital
        • Contact:
          • Yongmei Lin
      • Jinan, China
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Yuchen Fan
      • Lanzhou, China
        • Not yet recruiting
        • First Hospital of Lanzhou University
      • Weinan, China
        • Not yet recruiting
        • Weinan Central Hospital
        • Contact:
          • Hongbing Li
      • Xi'an, China
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, China
        • Not yet recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
          • Yu Li
      • Xi'an, China
        • Not yet recruiting
        • Air Force Medical University Tangdu Hospital
      • Xi'an, China
        • Not yet recruiting
        • Xi 'an International Medical Center Hospital
        • Contact:
          • Zhansheng Jia
      • Xianyang, China
        • Recruiting
        • Xianyang Central Hospital
        • Contact:
          • Wenxuan Zhao
      • Yanan, China
        • Not yet recruiting
        • The Affiliated Hospital of Yan'an University
        • Contact:
          • Na Liu
      • Yinchuan, China
        • Not yet recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
          • Xiangchun Ding
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients receive guideline-based systemic therapy. The follow-up assessments will be performed at week 1, 2, 3, 4, 12, 24 and 48 or any time if there is a change in condition. All the patients receive routine biochemical tests and imaging examinations.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ALF
acute liver failure
Procedure: ALF
Acute onset, no history of underlying liver disease, liver failure characterized by degree Ⅱ or above hepatic encephalopathy developed within 2 weeks
SALF
subacute liver failure
Procedure: 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
acute-on-chronic liver failure
Procedure: ACLF
On the basis of chronic liver disease, the clinical manifestations of acute liver decompensation and liver failure appear in a short period

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Director: Yingli He, Pro., First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2023

Primary Completion (Anticipated)

December 30, 2024

Study Completion (Anticipated)

December 30, 2028

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Estimate)

February 23, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2023LSK-019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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