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

Nanfang Hospital, Southern Medical University1,178 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,178

Conditions

Liver Failure, Acute on Chronic Liver Injury

Interventions

standard treatmentOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

28-day ACLF progression

progressed to EASL defined ACLF

Time frame: 28-day

28-day mortality

death within 28-day

Time frame: 28-day

Secondary Outcomes

90-day mortality

death within 90-day

Time frame: 90-day

Data from ClinicalTrials.gov

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