NCT03281265CompletedNot Applicable
A Retrospective Multicenter Study of HBV-related Pre-acute-on-chronic Liver Failure in China
Nanfang Hospital, Southern Medical University0 sites1,178 target enrollmentStarted: January 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,178
- Primary Endpoint
- 28-day ACLF progression
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •received liver transplantation or kidney transplantation before or after admission;
- •readmission;
- •death within 24 hours.
Outcomes
Primary Outcomes
28-day ACLF progression
Time Frame: 28-day
progressed to EASL defined ACLF
28-day mortality
Time Frame: 28-day
death within 28-day
Secondary Outcomes
- 90-day mortality(90-day)
Investigators
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