CompletedNot Applicable

A Retrospective Multicenter Study of HBV-related Pre-acute-on-chronic Liver Failure in China

1,178 participantsStarted 2012-01-01

Plain-language summary

The definition and diagnostic criteria of Acute-on-chronic liver failure (ACLF) has been well established by EASL CANONIC study. However, patients with high risk to develop ACLF has not been determined, yet. The aim of current study is to establish a preliminary pre-ACLF definition, and to demonstrate the corresponding risk factors.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Chronic hepatitis B virus infection;
✓. Any of the followings: Alanine aminotransferase (ALT)≥3 upper limit of laboratory reference (ULN); Aspartate aminotransferase (AST)≥3 ULN; Serum bilirubin≥2 ULN; Acute decompensation (ascites, hepatic encephalopathy, variceal hemorrhage and/or bacterial infections)

Exclusion criteria

✕. Previous decompensation;
✕. those who had hepatocellular carcinoma or other types of malignancies;
✕. those who combined with severe chronic extra-hepatic disease;
✕. pregnant;
✕. received liver transplantation or kidney transplantation before or after admission;
✕. readmission;
✕. death within 24 hours.

What they're measuring

28-day ACLF progression

Timeframe: 28-day

28-day mortality

Timeframe: 28-day

Trial details

NCT IDNCT03281265

SponsorNanfang Hospital, Southern Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-02-28

View on ClinicalTrials.gov More Liver Failure, Acute on Chronic trials