Clinical trial NCT05740696: Registry Study for Optimal Management of Liver Failure in the Chinese Population
Official title: Registry Study for Optimal Management of Liver Failure in the Chinese Population (RESOLVE-C)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Failure
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 28-day
measure: Overall survival
timeFrame: 90-day
Secondary outcomes:
measure: Disease progression
timeFrame: 48 weeks after discharge
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Ankang
country: China
facility: Ankang Central Hospital
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Hanzhong
country: China
facility: Hanzhong 3201 Hospital
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Lanzhou
country: China
facility: First Hospital of Lanzhou University
city: Weinan
country: China
facility: Weinan Central Hospital
city: Xi'an
country: China
facility: Air Force Medical University Tangdu Hospital
city: Xi'an
country: China
facility: Shaanxi provincial people's hospital
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Xi'an
country: China
facility: Xi 'an International Medical Center Hospital
city: Xianyang
country: China
facility: Xianyang Central Hospital
city: Yanan
country: China
facility: The Affiliated Hospital of Yan'an University
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yingli He, Pro.
role: STUDY_DIRECTOR
References: