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Trial record 12 of 582 for:    bilirubin AND liver function

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

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ClinicalTrials.gov Identifier: NCT02650011
Recruitment Status : Suspended
First Posted : January 8, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dong Joon Kim, 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.

Condition or disease Intervention/treatment
Chronic Liver Disease Acute Derangement of Liver Function Other: Acute deterioration of liver function

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.

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Study Type : Observational
Estimated Enrollment : 1520 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : October 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Group/Cohort Intervention/treatment
ACLF cohort
Patients who have chronic liver disease and admitted for acute deterioration of liver function
Other: 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




Primary Outcome Measures :
  1. Overall mortality of patients with ACLF [ Time Frame: up to 21 months ]
    Overall mortality of ACLF in original cohort


Secondary Outcome Measures :
  1. Overall rate of liver transplantation in patients with ACLF [ Time Frame: up to 21 months ]
    Overall rate of liver transplantation in original cohort

  2. Short term mortality of patients with ACLF [ Time Frame: 28 day and 90 day of observation ]
    Short term mortality of ACLF in original cohort

  3. Short term rate of liver transplantation in patients with ACLF [ Time Frame: 28 day and 90 day of observation ]
    Short term rate of liver transplantation in original cohort



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have chronic liver disease and admitted for acute deterioration of liver function (ACLF)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650011


Locations
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Korea, Republic of
Chuncheon Sacred Heart hospital
Chuncheon, Korea, Republic of
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Investigators
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Principal Investigator: Dong Joon Kim, M.D., Ph.D. Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

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Responsible Party: 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, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT02650011     History of Changes
Other Study ID Numbers: P-KACLiF
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

Keywords provided by Dong Joon Kim, Chuncheon Sacred Heart Hospital:
Chronic liver disease
Liver cirrhosis

Additional relevant MeSH terms:
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Liver Diseases
Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Digestive System Diseases
Liver Failure, Acute
Liver Extracts
Hematinics