NCT05740696

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2023Dec 2028

Study Start

First participant enrolled

January 6, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Expected
Last Updated

February 23, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

February 8, 2023

Last Update Submit

February 22, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    28-day survival rates without liver transplantation

    28-day

  • Overall survival

    90-day survival rates without liver transplantation

    90-day

Secondary Outcomes (1)

  • Disease progression

    48 weeks after discharge

Study Arms (3)

ALF

acute liver failure

Procedure: ALF

SALF

subacute liver failure

Procedure: SALF

ACLF

acute-on-chronic liver failure

Procedure: ACLF

Interventions

ALFPROCEDURE

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

ALF
SALFPROCEDURE

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

SALF
ACLFPROCEDURE

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

ACLF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • An event or complication that, in the judgment of the investigator, significantly affects the assessment of clinical status.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Ankang Central Hospital

Ankang, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, China

NOT YET RECRUITING

Hanzhong 3201 Hospital

Hanzhong, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, China

NOT YET RECRUITING

First Hospital of Lanzhou University

Lanzhou, China

NOT YET RECRUITING

Weinan Central Hospital

Weinan, China

NOT YET RECRUITING

Air Force Medical University Tangdu Hospital

Xi'an, China

NOT YET RECRUITING

Shaanxi provincial people's hospital

Xi'an, China

NOT YET RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

RECRUITING

Xi 'an International Medical Center Hospital

Xi'an, China

NOT YET RECRUITING

Xianyang Central Hospital

Xianyang, China

RECRUITING

The Affiliated Hospital of Yan'an University

Yanan, China

NOT YET RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, China

NOT YET RECRUITING

Related Publications (1)

  • Liu Y, Zhang Q, Li J, Wu X, Zang Q, Wang Q, Huang P, Wang Y, Zhang S, Liu S, Zhu C, Zhao Y, Yan T, He Y. mNGS improves the efficiency of infection diagnosis and treatment in acute-on-chronic liver failure. BMC Gastroenterol. 2026 Jan 20. doi: 10.1186/s12876-025-04601-8. Online ahead of print.

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Yingli He, Pro.

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 23, 2023

Study Start

January 6, 2023

Primary Completion

December 30, 2024

Study Completion (Estimated)

December 30, 2028

Last Updated

February 23, 2023

Record last verified: 2023-01

Locations