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NCT Number: NCT05740696

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

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.

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Key information

Conditions

Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALF

Procedure

Acute onset, no history of underlying liver disease, liver failure characterized by degree Ⅱ or above hepatic encephalopathy developed within 2 weeks

SALF

Procedure

The onset was acute, with no history of underlying liver disease, and clinical manifestations of liver failure appeared between 2 and 26 weeks

ACLF

Procedure

On the basis of chronic liver disease, the clinical manifestations of acute liver decompensation and liver failure appear in a short period

Primary outcomes

  1. Overall survival

    Time frame: 28-day

    28-day survival rates without liver transplantation

  2. Overall survival

    Time frame: 90-day

    90-day survival rates without liver transplantation

Secondary outcomes

  1. Disease progression

    Time frame: 48 weeks after discharge

    Incidence of complications and re-hospitalization at 48 weeks after discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Li, M.D.

CONTACT

[email protected]

0086-18209272726

Yingli He, Pro.

CONTACT

[email protected]

0086-18991232863

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: RESOLVE-C

Important dates

Study start
2023
Primary completion
2024
Study completion
2028
First posted
Feb 23, 2023
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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