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

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 Overview

• Status: Completed
• Conditions: Liver Injury; Liver Failure, Acute on Chronic
• Intervention / Treatment: Other: standard treatment

• Study Type: Observational
• Enrollment (Actual): 1178

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with HBV-related compensated liver disease and acute liver injury or decompensation.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	death within 28-day	28-day
28-day ACLF progression	progressed to EASL defined ACLF	28-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day mortality	death within 90-day	90-day

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: hepatitis B; pre-acute-on-chronic liver failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Liver Failure, Acute
• Other Study ID Numbers: 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No