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Chinese CLIF-C Acute-on-Chronic Liver Disease and Liver Failure Study

NCT02457637 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2600

Last updated 2020-08-11

Study results available
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Summary

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.

Conditions

  • Liver Failure, Acute on Chronic

Interventions

OTHER

Standary therapy

Standary therapy for chronic liver disease with ALI and/or AD

Sponsors & Collaborators

  • Hai Li

    lead OTHER

Principal Investigators

  • Hai Li · RenJi Hospital

Eligibility

Min Age
15 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2016-12-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02457637 on ClinicalTrials.gov