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

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ClinicalTrials.gov Identifier: NCT03281265
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of 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.

Condition or disease Intervention/treatment
Liver Failure, Acute on Chronic Liver Injury Other: standard treatment

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Study Type : Observational
Actual Enrollment : 1178 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Multicenter Study of HBV-related Pre-acute-on-chronic Liver Failure in China
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017



Primary Outcome Measures :
  1. 28-day ACLF progression [ Time Frame: 28-day ]
    progressed to EASL defined ACLF

  2. 28-day mortality [ Time Frame: 28-day ]
    death within 28-day


Secondary Outcome Measures :
  1. 90-day mortality [ Time Frame: 90-day ]
    death within 90-day



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with HBV-related compensated liver disease and acute liver injury or decompensation.
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.
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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03281265    
Other Study ID Numbers: 002
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanfang Hospital of Southern Medical University:
pre-acute-on-chronic liver failure
hepatitis B
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Failure, Acute
Liver Diseases
Digestive System Diseases