Clinical trial NCT02650011: Clinical Features and Natural History of Acute-on-Chronic Liver Failure in Korean Patients With Chronic Liver Disease
Official title: The Clinical Features and Natural History of Acute-on-Chronic Liver Failure in Korean Patients With Chronic Liver Disease: Multicenter, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Chronic Liver Disease
Acute Derangement of Liver Function
Keywords: Chronic liver disease
Liver cirrhosis
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 1520
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have chronic liver disease and admitted for acute deterioration of liver function (ACLF)

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall mortality of patients with ACLF
timeFrame: up to 21 months
Secondary outcomes:
measure: Overall rate of liver transplantation in patients with ACLF
timeFrame: up to 21 months
measure: Short term mortality of patients with ACLF
timeFrame: 28 day and 90 day of observation
measure: Short term rate of liver transplantation in patients with ACLF
timeFrame: 28 day and 90 day of observation
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart hospital
Study officials:
affiliation: Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
name: Dong Joon Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: