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

Chronic Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02650011
• Other study ID #: P-KACLiF
• Status: Suspended
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 1520
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Derangement of Liver Function
• Acute-On-Chronic Liver Failure
• Chronic Liver Disease
• End Stage Liver Disease
• Liver Diseases
• Liver Failure

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Chuncheon Sacred Heart hospital	Chuncheon

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality of patients with ACLF	Overall mortality of ACLF in original cohort	up to 21 months
Secondary	Overall rate of liver transplantation in patients with ACLF	Overall rate of liver transplantation in original cohort	up to 21 months
Secondary	Short term mortality of patients with ACLF	Short term mortality of ACLF in original cohort	28 day and 90 day of observation
Secondary	Short term rate of liver transplantation in patients with ACLF	Short term rate of liver transplantation in original cohort	28 day and 90 day of observation