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

NCT02650011 | Suspended

• 1 other identifier: P-KACLiF
• Study Type: observational
• Target: 1,520
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease; Acute Derangement of Liver Function

Keywords

Chronic liver disease; Liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• Overall mortality of patients with ACLF

  Overall mortality of ACLF in original cohort

  up to 21 months

Secondary Outcomes (3)

• Overall rate of liver transplantation in patients with ACLF

  up to 21 months

• Short term mortality of patients with ACLF

  28 day and 90 day of observation

• Short term rate of liver transplantation in patients with ACLF

  28 day and 90 day of observation

Study Arms (1)

ACLF cohort

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

Other: Acute deterioration of liver function

Interventions

Acute deterioration of liver function 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

ACLF cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Chuncheon Sacred Heart hospital

Chuncheon, South Korea

Location

Related Publications (1)

• Kim TH, Yim HJ, Jung YK, Song DS, Yoon EL, Kim HY, Kang SH, Chang Y, Yoo JJ, Jun BG, Lee SW, Park JG, Park JW, Kim SE, Kim TY, Jeong SW, Suk KT, Kim MY, Kim SG, Kim W, Jang JY, Yang JM, Kim DJ; Korean Acute-on-Chronic Liver Failure (KACLiF) Study Group. New prognostic model for hospitalized patients with alcoholic cirrhosis and Maddrey's discriminant function <32. Hepatol Int. 2024 Apr;18(2):500-508. doi: 10.1007/s12072-023-10582-1. Epub 2023 Oct 13.

  PMID: 37831433 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong Joon Kim, M.D., Ph.D.

  Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief, Division of Gastroenterology and Hepatology Hallym University College of Medicine / Director, Center for Liver and Digestive Diseases Hallym University Medical Center

Study Record Dates

• First Submitted: July 25, 2015
• First Posted: January 8, 2016
• Study Start: October 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

KR (1)