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

ConditionLiver Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • ALF

    Procedure/Surgery

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

  • SALF

    Procedure/Surgery

    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/Surgery

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

Treatment groups

500 Participants
are divided into 3 treatment groups
Group A: ALF1 intervention
Group B: SALF1 intervention
Group C: ACLF1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

28-day survival rates without liver transplantation

Time frame
28-day
2

Overall survival

90-day survival rates without liver transplantation

Time frame
90-day

Secondary outcomes

1

Disease progression

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

Time frame
48 weeks after discharge

Other outcomes

Sponsors and contacts

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