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

Completed

• Conditions: Liver Injury; Liver Failure, Acute on Chronic

• Registration Number: NCT03281265
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2017-07
• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1178

Inclusion Criteria

1. Chronic hepatitis B virus infection;
2. 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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day ACLF progression	28-day	progressed to EASL defined ACLF
28-day mortality	28-day	death within 28-day

Secondary Outcome Measures

Name	Time	Method
90-day mortality	90-day	death within 90-day