- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02650011
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
Status
Suspended
Intervention / Treatment
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
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Chuncheon, Korea, Republic of
- Chuncheon Sacred Heart Hospital
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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
- 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
- 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
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Overall mortality of ACLF in original cohort
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up to 21 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall rate of liver transplantation in patients with ACLF
Time Frame: up to 21 months
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Overall rate of liver transplantation in original cohort
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up to 21 months
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Short term mortality of patients with ACLF
Time Frame: 28 day and 90 day of observation
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Short term mortality of ACLF in original cohort
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28 day and 90 day of observation
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Short term rate of liver transplantation in patients with ACLF
Time Frame: 28 day and 90 day of observation
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Short term rate of liver transplantation in original cohort
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28 day and 90 day of observation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-KACLiF
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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