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

NCT02457637 | Completed Results

• 1 other identifier: CHINA-ACLF
• Study Type: observational
• Target: 2,600
• Locations: 1 country
• Sites: 16

Brief 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

Keywords

acute-on-chronic liver disease; acute decompensation; multiple organ failures; acute on chronic liver failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 90-day Mortality Rates, 90-day Liver Transplantation Free Mortality and Liver Transplantation Rate

  up to 90 days

• 180-day Mortality Rate and Liver Transplantation Rate

  up to 180 days

Other Outcomes (3)

• The Appearance and Number of Organ Failure

  Up to 28 days

• Models for Disease Severity

  Up to 28 days

• Serum Bilirubin

  Up to 28 days

Study Arms (1)

Acute-on-Chronic Liver Disease Inpatient

1. chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients; and non-alcoholic fatty liver disease patients. 2. ALI(acute liver injury): including \[ALT\>3NL(normal level),AST\>3NL or TB\>2NL within 1 week before enrollment\] or AD(acute decompensation) : including \[(having ascites, hepatic encephalopathy, bacterial infection gastrointestinal bleeding or jaundice(TB\>5NL)within 1 month before enrollment)\]. 3. Standary therapy

Other: Standary therapy

Interventions

Standary therapy OTHER

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

Acute-on-Chronic Liver Disease Inpatient

Eligibility Criteria

• Age: 15 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

chronic liver disease patients（having liver dysfunction more than 6 months） with acute liver injury\[having ALT(alanine aminotransferase)\>3NL(normal level),AST(aspartate aminotransferase)\>3NL or TB(total bilirubin)\>2NL within 1 week before enrollment\] or acute decompensation\[having ascites, hepatic encephalopathy, bacterial infection ,gastrointestinal bleeding or jaundice(TB\>5NL)within 1 month before enrollment\].

You may qualify if:

• 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\[having ascites, hepatic encephalopathy, bacterial infection ,gastrointestinal bleeding or jaundice(TB\>5NL)within 1 month\].

You may not qualify if:

• 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

Sponsors & Collaborators

• Hai Li: lead

Study Sites (16)

Ditan Hospital of integrated traditional Chinese and Western Medicine Center

Beijing, Beijing Municipality, 100015, China

Location

Southwest Hospital of Third Military Medical University

Chongqing, Chongqing Municipality, 400038, China

Location

Fuzhou general hospital of Xiamen university

Fuzhou, Fujian, 350025, China

Location

Southern hospital infection department

Guangzhou, Guangdong, 510515, China

Location

Affiliated Hospital of the Armed Police Logistics College

Tianjingcun, Hebei, 250033, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Taihe Hospital

Shiyan, Hubei, 442000, China

Location

Wuhan Union Hospital of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Xiangya hospital of Central South University

Changsha, Hunan, 410008, China

Location

The First Affiliated Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The Second Hospital of Shandong University

Jinan, Shandong, 250033, China

Location

Fudan University Huashan hospital

Shanghai, Shanghai Municipality, 200001, China

Location

Fudan University Zhongshan hospital

Shanghai, Shanghai Municipality, 200001, China

Location

Renji hospital of Shanghai Jiao Tong University School of Medical

Shanghai, Shanghai Municipality, 200001, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200083, China

Location

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

Related Publications (19)

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  PMID: 22806618 BACKGROUND

• Gu WY, Xu BY, Zheng X, Chen J, Wang XB, Huang Y, Gao YH, Meng ZJ, Qian ZP, Liu F, Lu XB, Shang J, Li H, Wang SY, Sun X, Li H. Acute-on-Chronic Liver Failure in China: Rationale for Developing a Patient Registry and Baseline Characteristics. Am J Epidemiol. 2018 Sep 1;187(9):1829-1839. doi: 10.1093/aje/kwy083.

  PMID: 29762630 RESULT

• Zhang Y, Tan W, Wang X, Zheng X, Huang Y, Li B, Meng Z, Gao Y, Qian Z, Liu F, Lu X, Shi Y, Shang J, Yan H, Zheng Y, Zhang W, Gu W, Qiao L, Deng G, Zhou Y, Hou Y, Zhang Q, Xiong S, Liu J, Duan L, Chen R, Chen J, Jiang X, Luo S, Chen Y, Jiang C, Zhao J, Ji L, Mei X, Li J, Li T, Zheng R, Zhou X, Ren H, Cheng X, Guo L, Li H; Chinese (Acute on) Chronic Liver Failure Consortium (Ch-CLIF.C). Metabolic biomarkers significantly enhance the prediction of HBV-related ACLF occurrence and outcomes. J Hepatol. 2023 Nov;79(5):1159-1171. doi: 10.1016/j.jhep.2023.07.011. Epub 2023 Jul 29.

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Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, urine, stool, liver tissue

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1. ACLF has no pathological criteria yet thus the diagnosis is made based on clinical data and mortality. 2. The diagnosis of cirrhosis was based on both clinical data and imaging instead of liver biopsy.

Results Point of Contact

• Title: Professor Hai Li , Director of Clinical Trials
• Organization: Renji Hospital, Shanghai Jiao Tong University School of Medical

haili＿17@126.cpm

+86-13818525494

Study Officials

• Hai Li

  RenJi Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Gastroenterology, RenJi Hospital ; Vice Director of the National Digestive Key Laboratory; Youth Commission of Chinese Society of Hepatology.

Study Record Dates

• First Submitted: January 31, 2015
• First Posted: May 29, 2015
• Study Start: January 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2019
• Last Updated: August 11, 2020
• Results First Posted: January 22, 2020

Record last verified: 2020-08

Locations

CN (16)