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

NCT ID: NCT03281265

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1178 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2017-02-28

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.

Conditions

Liver Failure, Acute on Chronic; Liver Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

standard treatment

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

002

Identifier Type: -

Identifier Source: org_study_id