Liver Failure, Acute on Chronic Clinical Trial
— Ch-CANONICOfficial title:
Chinese Chronic Liver Failure Consortium Acute-on-Chronic Liver Disease and Failure Study ——a Prospective Multi-center Study in China, the Largest Hepatitis B Virus High-endemic Region.
Verified date | August 2020 |
Source | Shanghai Jiao Tong University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Acute on chronic liver failure (ACLF) is a distinct entity encompassing the acute
deterioration of liver function, culminating in multiple organs failure and high short-term
mortality. Currently, there are differences in definitions and descriptions between western
and eastern types of ACLF, especially in the definition of chronic liver disease and its
precipitating events. The CANONIC (EASL-CLIF ACLF in Cirrhosis) study put forward CLIF-SOFA
(chronic liver failure-sequential organ failure assessment) scores as the clinical diagnostic
criteria of ACLF in 2013. Although the Asian Pacific Association for the Study of the Liver
(APASL) reached a consensus for diagnostic criteria of ACLF in 2008, it is based on expert
opinion. This prospective multicenter clinical trial is launched to clarify the eastern type
of ACLF (HBV related) and estimate whether the eastern and western (alcoholic related) types
are homogenous. 3 key points of concern are: (1) Whether HBV and non-HBV ACLFs are belonged
to a homogenous disease entity which share the same diagnostic criteria, disease grades
classification and prognostic model? (2) Whether acute deteriorating patients from cirrhosis
or from mild fibrosis (S1-S2) belong to a homogenous entity? (3) To clarify if there are
heterogenous groups in APASL criteria diagnosed ACLF patients.
14 Chinese national wide liver centers have been included. Continuous hospitalized chronic
liver disease patients of various etiologies (including both cirrhotic and non-cirrhotic)
with acute decompensation (AD) or acute hepatic injury (ALI) (aminotransferase > 3NL(normal
level)) will be recruited from January to December 2015. Biochemical parameters, organ
failure will be collected and evaluated at day 1,4,7,14,21 and 28 after enrollment.
Patients'death and LT (liver transplantation) are the primary and secondary endpoints of
observation. Mortality and LT rate will be calculated at 28 days,90 days,180 days,1 year and
2 years after enrollment. Considering there will lack of liver biopsy in most of the
patients, both CT and FibroScan as supplementary methods to differentiate non-cirrhotic
patients. The patients will be continuously followed up once a month until the 24th month
after hospital discharging and follow similar hospitalization process again whenever they
have new ALI or AD. Data about the patients from stable chronic liver disease to
deterioration will be acquired analyzed according to the questions hoped to resolve.
Status | Completed |
Enrollment | 2600 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 79 Years |
Eligibility |
Inclusion Criteria: - inpatient (hospitalization >1 days)(including patient in emergency observation wards) - chronic liver disease patients including non-alcoholic fatty liver disease patients,chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients and decompensated cirrhosis patients - having acute liver injury [ALT(alanine aminotransferase)>3NL(normal level),AST(aspartate aminotransferase)>3NL or TB(total bilirubin)>2NL within 1 week before enrollment] or acute decompensation[having ascites, hepatic encephalopathy, bacterial infection ,gastrointestinal bleeding or jaundice(TB>5NL)within 1 month]. Exclusion Criteria: - pregnancy - hepatocellular carcinoma or other liver malignancies - malignancy of other organs - severe chronic extrahepatic disease including chronic obstructive pulmonary disease combined with respiratory failure, coronary heart disease with cardiac function level 3 (NYHA), myocardial infarction in the 3 months before admission, diabetes with severe complications and chronic kidney disease with end-stage renal failure - receiving immunosuppressive drugs for reasons other than chronic liver disease |
Country | Name | City | State |
---|---|---|---|
China | Ditan Hospital of integrated traditional Chinese and Western Medicine Center | Beijing | Beijing |
China | The First Affiliated Hospital of Jilin University | Changchun | Jilin |
China | Xiangya hospital of Central South University | Changsha | Hunan |
China | Southwest Hospital of Third Military Medical University | Chongqing | Chongqing |
China | Fuzhou general hospital of Xiamen university | Fuzhou | Fujian |
China | Southern hospital infection department | Guangzhou | Guangdong |
China | The Second Hospital of Shandong University | Jinan | Shandong |
China | Fudan University Huashan hospital | Shanghai | Shanghai |
China | Fudan University Zhongshan hospital | Shanghai | Shanghai |
China | Renji hospital of Shanghai Jiao Tong University School of Medical | Shanghai | Shanghai |
China | Shanghai Public Health Clinical Center | Shanghai | Shanghai |
China | Taihe Hospital | Shiyan | Hubei |
China | Affiliated Hospital of the Armed Police Logistics College | Tianjing | Hebei |
China | The First Teaching Hospital of Xinjiang Medical University | Ürümqi | Xinjiang |
China | Wuhan Union Hospital of Huazhong University of Science and Technology | Wuhan | Hubei |
China | Henan Provincial People's Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Hai Li |
China,
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Jalan R, Saliba F, Pavesi M, Amoros A, Moreau R, Ginès P, Levesque E, Durand F, Angeli P, Caraceni P, Hopf C, Alessandria C, Rodriguez E, Solis-Muñoz P, Laleman W, Trebicka J, Zeuzem S, Gustot T, Mookerjee R, Elkrief L, Soriano G, Cordoba J, Morando F, Gerbes A, Agarwal B, Samuel D, Bernardi M, Arroyo V; CANONIC study investigators of the EASL-CLIF Consortium. Development and validation of a prognostic score to predict mortality in patients with acute-on-chronic liver failure. J Hepatol. 2014 Nov;61(5):1038-47. doi: 10.1016/j.jhep.2014.06.012. Epub 2014 Jun 17. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The Appearance and Number of Organ Failure | The appearance and number of organ failure(including liver, coagulation, renal, circulation, brain, respiratory system) will be evaluated and reported at 1, 4, 7, 14, 21 and 28 days (or last visit)during patients' hospitalization. | Up to 28 days | |
Other | Models for Disease Severity | MELD score, MELD-Na score, CLIF-SOFA score, SOFA score and APACHE scores will be calculated and reported at 1, 4, 7, 14, 21 and 28 days (or last visit) during patients' hospitalization. MELD:Model for end-stage liver disease MELD-Na: Model for end-stage liver disease - sodium SOFA:sequential organ failure assessment CLIF-SOFA:chronic liver failure-sequential organ failure assessment APACHE:Acute Physiology And Chronic Health Evaluation |
Up to 28 days | |
Other | Serum Bilirubin | be collected and reported at 28 or last visit before discharge | Up to 28 days | |
Primary | 28-day Mortality,28-day Liver-transplantation Free Mortality& 28-day Liver Transplantation Rate | liver-transplantation free mortality refers to number of participants who died in the absence of receiving a liver transplant divided by number of participants without liver transplant. | up to 28 days | |
Secondary | 90-day Mortality Rates, 90-day Liver Transplantation Free Mortality and Liver Transplantation Rate | liver-transplantation free mortality refers to number of participants who died in the absence of receiving a liver transplant divided by number of participants without liver transplant. | up to 90 days | |
Secondary | 180-day Mortality Rate and Liver Transplantation Rate | Mortality will be respectively calculated together with the liver transplantation rate (as the rate of ''incidence'')and independently (as the ''liver transplantation free mortality'') respectively. | up to 180 days |
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