Chronic Liver DiseaseNCT02650011
Clinical Features and Natural History of Acute-on-Chronic Liver Failure in Korean Patients With Chronic Liver Disease
An observational study of Chronic Liver Disease and Acute Derangement of Liver Function, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Liver Disease, Acute Derangement of Liver Function
- What is being tested?
- Acute deterioration of liver function
- How many people
- 1,520 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have chronic liver disease and admitted for acute deterioration of liver function (ACLF)
Who may be able to join
- 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)
Show all 17Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Acute deterioration of liver function
- Keywords
- Chronic liver disease, Liver cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute deterioration of liver functionOther
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
| Study group | Role | What they receive |
|---|---|---|
| ACLF cohort | Patients who have chronic liver disease and admitted for acute deterioration of liver function Receives: Other: Acute deterioration of liver function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality of patients with ACLF
Overall mortality of ACLF in original cohort
Measured: up to 21 months
Secondary outcomes (3)
Overall rate of liver transplantation in patients with ACLF
Overall rate of liver transplantation in original cohort
Measured: up to 21 months
Short term mortality of patients with ACLF
Short term mortality of ACLF in original cohort
Measured: 28 day and 90 day of observation
Short term rate of liver transplantation in patients with ACLF
Short term rate of liver transplantation in original cohort
Measured: 28 day and 90 day of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Joon Kim, Chuncheon Sacred Heart Hospital
- Investigators
- Dong Joon Kim, M.D., Ph.D., Principal investigator, Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650011
- Sponsor's protocol ID
- P-KACLiF
- Status last verified
- Jul 2018
- First submitted
- 25 Jul 2015
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37831433
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02650011
- Acronym / sponsor ID
- P-KACLiF
- Keywords
- Chronic liver disease, Liver cirrhosis
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 1,520 participants (estimated)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACLF cohort | – | Other: Acute deterioration of liver functionPatients who have chronic liver disease and admitted for acute deterioration of liver function |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have chronic liver disease and admitted for acute deterioration of liver function (ACLF)
Key inclusion criteria (17 listed)
- 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
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute deterioration of liver functiondevelopment 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 | Other | ACLF cohort |
Primary outcome
Overall mortality of patients with ACLF
Time frame: up to 21 months
Overall mortality of ACLF in original cohort
3 secondary outcomes
Overall rate of liver transplantation in patients with ACLF
Time frame: up to 21 months
Short term mortality of patients with ACLF
Time frame: 28 day and 90 day of observation
Short term rate of liver transplantation in patients with ACLF
Time frame: 28 day and 90 day of observation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Derived from this study: PubMed 37831433Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Joon Kim, M.D., Ph.D. principal investigator
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease and Acute Derangement of Liver Function, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall mortality of patients with ACLF (time frame: up to 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02650011, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.