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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

1520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Liver Disease Acute Derangement of Liver Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ACLF cohort

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

Acute deterioration of liver function

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Dong Joon Kim

Professor and Chief, Division of Gastroenterology and Hepatology Hallym University College of Medicine / Director, Center for Liver and Digestive Diseases Hallym University Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR