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

Suspended

• Conditions: Chronic Liver Disease; Acute Derangement of Liver Function
• Interventions: Other: Acute deterioration of liver function

• Registration Number: NCT02650011
• Lead Sponsor: Chuncheon Sacred Heart Hospital

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.

Study Timeline

• Study First Submitted: 2015-07-25
• Study Start: 2015-10
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 1520

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ACLF cohort	Acute deterioration of liver function	Patients who have chronic liver disease and admitted for acute deterioration of liver function

Primary Outcome Measures

Name	Time	Method
Overall mortality of patients with ACLF	up to 21 months	Overall mortality of ACLF in original cohort

Secondary Outcome Measures

Name	Time	Method
Overall rate of liver transplantation in patients with ACLF	up to 21 months	Overall rate of liver transplantation in original cohort
Short term mortality of patients with ACLF	28 day and 90 day of observation	Short term mortality of ACLF in original cohort
Short term rate of liver transplantation in patients with ACLF	28 day and 90 day of observation	Short term rate of liver transplantation in original cohort

Trial Locations

Locations (1)

Chuncheon Sacred Heart hospital; 🇰🇷 Chuncheon, Korea, Republic of