Clinical Features and Natural History of Acute-on-Chronic Liver Failure in Korean Patients With Chronic Liver Disease

July 16, 2018 updated by: Dong Joon Kim, Chuncheon Sacred Heart Hospital

The Clinical Features and Natural History of Acute-on-Chronic Liver Failure in Korean Patients With Chronic Liver Disease: Multicenter, Prospective Cohort Study

Chronic liver disease including liver cirrhosis is still associated with high mortality, although advancement of medical management and transplantation. Acute-on-chronic liver failure (ACLF) refers to condition of previously stable chronic liver disease with occurrence of an acute insult resulting in rapid deterioration of liver function and subsequent decompensation. This condition is different from liver cirrhosis (chronic hepatic decompensation) in terms of having more chance of recovery with management before acute deterioration, although it shows high short-term mortality. Thus, earlier recognition and intensive management are important for this condition. However, the definition or diagnostic criteria is unclear and the natural course of this condition is not definitely investigated. The aim of this study is to establish the natural course of ACLF in Korean patients.

Study Overview

Detailed Description

Chronic liver disease including liver cirrhosis is still associated with high mortality, although advancement of medical management and transplantation. Acute-on-chronic liver failure (ACLF) refers to condition of previously stable chronic liver disease with occurrence of an acute insult resulting in rapid deterioration of liver function and subsequent decompensation. Various factors could be a precipitating factor of ACLF. This condition is different from liver cirrhosis (chronic hepatic decompensation) in terms of having more chance of recovery with management before acute deterioration, although it shows high short-term mortality. Thus, earlier recognition and intensive management are important for this condition. However, the definition or diagnostic criteria is unclear and the natural course of this condition is not definitely investigated. The aim of this study is to establish the common etiology, symptom and natural course of ACLF in Korean patients.

Study Type

Observational

Enrollment (Anticipated)

1520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have chronic liver disease and admitted for acute deterioration of liver function (ACLF)

Description

Inclusion Criteria:

  • Chronic liver disease: Chronic hepatitis B, Chronic hepatitis C, Alcoholic liver disease, Biopsy proven or clinically diagnosed liver cirrhosis, Other chronic liver diseases including non-alcoholic fatty liver disease, primary biliary cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, a-1 antitrypsin deficiency, and cryptogenic causes.
  • Acute deterioration of liver function: more than one of the below criteria

    1. development of new ascites within 4 weeks or re-emergence of ascites who have previous well controlled ascites (greater than or equal to grade 2 or 3; International ascites club criteria)
    2. development of hepatic encephalopathy
    3. development of gastrointestinal hemorrhage
    4. development of jaundice (serum bilirubin greater than or equal to 3mg/dl)
    5. development of bacterial infection
  • spontaneous bacteremia: positive blood cultures without a source of infection
  • spontaneous bacterial peritonitis: ascitic fluid polymorphonuclear cells >250/µL
  • lower respiratory tract infections: new pulmonary infiltrate in the presence of: i) at least one respiratory symptom (cough, sputum production, dyspnea, pleuritic pain) with ii) at least one finding on auscultation (rales or crepitation) or one sign of infection (core body temperature >38_C or less than 36_C, shivering, or leukocyte count >10,000/mm3 or <4,000/mm3) in the absence of antibiotics
  • Clostridium difficile Infection: diarrhea with a positive C. difficile assay
  • bacterial entero-colitis: diarrhea or dysentery with a positive stool culture for Salmonella, Shigella, Yersinia, Campylobacter, or pathogenic E. coli;
  • soft-tissue/skin Infection: fever with cellulitis
  • urinary tract infection (UTI): urine white blood cell >15/high-power field with either positive urine gram stain or culture;
  • intra-abdominal infections: diverticulitis, appendicitis, cholangitis, etc.
  • other infections not covered above;
  • fungal infections as a separate category.

Exclusion Criteria:

  • Patients who do not have chronic liver disease
  • Patients who have hepatocellular carcinoma
  • Patients who admitted for extrahepatic manifestations
  • Patients who have HIV infection
  • Patients who admitted for symptomatic control of chronic liver disease, other than acute deterioration of liver function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ACLF cohort
Patients who have chronic liver disease and admitted for acute deterioration of liver function
development of new ascites within 4 weeks or re-emergence of ascites who have previous well controlled ascites (greater than or equal to grade 2 or 3; International ascites club criteria) development of hepatic encephalopathy development of gastrointestinal hemorrhage development of jaundice (serum bilirubin greater than or equal to 3mg/dl) development of bacterial infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall mortality of patients with ACLF
Time Frame: up to 21 months
Overall mortality of ACLF in original cohort
up to 21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall rate of liver transplantation in patients with ACLF
Time Frame: up to 21 months
Overall rate of liver transplantation in original cohort
up to 21 months
Short term mortality of patients with ACLF
Time Frame: 28 day and 90 day of observation
Short term mortality of ACLF in original cohort
28 day and 90 day of observation
Short term rate of liver transplantation in patients with ACLF
Time Frame: 28 day and 90 day of observation
Short term rate of liver transplantation in original cohort
28 day and 90 day of observation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dong Joon Kim, M.D., Ph.D., Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 25, 2015

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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