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A Validation Cohort for ACLF Diagnosis and Prognosis (Ch-CANONIC-Val)

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ClinicalTrials.gov Identifier: NCT03641872
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hai Li, Shanghai Jiao Tong University School of Medicine

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. Definitions and descriptions of ACLF vary between Western and Eastern types, and alcoholism and hepatitis B virus (HBV) are the main etiologies, respectively. To determine whether there are unified diagnostic criteria, severity classification and prognostic model for different etiologies of ACLF. Investigators had launched a multicenter prospective cohort with the same inclusion criteria and disease indicators as those used in the European CANONIC (Chronic liver failure-ACLF in Cirrhosis) study in China,the Ch-CANONIC study(NCT02457637). From Jan 2015 to Dec 2016, 2,600 inpatients with chronic liver disease complicated with ALI and/or AD were recruited. Data were collected during a 28-day hospitalization and continuous follow-ups were performed once a month until 36 months after hospitalization (at least 18 months up to now). Of these patients, 71.5% had HBV-related disease, 1833 had cirrhotic disease, and 767 had non-cirrhotic disease diagnosed by CT scan.

Due to the lack of pathological gold standards, the diagnosis of ACLF is based on the clinical assessment of short-term mortality from organ functional parameters. In subsequent statistics and data analysis, investigators focused on (but not limit in) the relationship between short-term mortality and 6 parameters (bilirubin, INR, Creatinine, SpO2/FiO2, mean arterial pressure and West-Haven grade) from CLIF-C OFs (Chronic liver failure-Consortium Organ Failure score). And then a specific mathematical model has been constructed to obtain the available organ failure cutoff values. Subsequently, investigators carried out a diagnostical criteria for ACLF based on the results obtained from the model and get a good internal-validation result through risk ratio. Meanwhile, investigators conducted a precise prediction model for patients' prognosis and achieved a good predictive effect with consistency by AUC internal-validation. In addition, investigators summarized the course and some characteristics of ACLF.

Therefore, investigators hope to launch another prospective multi-center cohort study with the same inclusion and exclusion criteria, and continue to recruit 800 to 900 patients (about 30% of the previous cohort) as the external validation cohort for the preliminary results mentioned above.


Condition or disease Intervention/treatment
Liver Failure, Acute on Chronic Liver Dysfunction Other: Standary therapy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multi-center Validating Cohort for ACLF Diagnosis and Prognosis From Ch-CANONIC Study
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Group/Cohort Intervention/treatment
Acute-on-Chronic Liver Disease
  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 > 3 ULN(upper limited of normal),AST > 3 ULN or TB > 2 ULN within 1 week before enrollment] or AD(acute decompensation) : including [(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding and/or jaundice(TB > 5 ULN) within 1 month before enrollment)].
  3. Standary therapy for chronic liver disease with ATI and/or AD
Other: Standary therapy
Standary therapy for chronic liver disease with ALI and/or AD




Primary Outcome Measures :
  1. Short-Term Mortality & [ Time Frame: Up to 3 months ]
    Mortality will be calculated and reported at 28 days,90 days.

  2. Short-Term Liver Transplantation Rate [ Time Frame: Up to 3 months ]
    Liver Transplantation Rate will be calculated and reported at 28 days,90 days.Those who undergoing liver transplantation are patients developed life-threatening liver failure. If those patients do not got a chance of transplantation, there would be a high probability that they could die in a very short period of time.So Liver Transplantation Rate is also a Primary Outcome Measure.


Secondary Outcome Measures :
  1. the Appearance of liver failure [ Time Frame: Up to 28 days ]
    The appearance of liver failure will be evaluated and reported at the 1st day, once a week and last visit during patients' hospitalization.

  2. the Appearance of coagulation failure [ Time Frame: Up to 28 days ]
    The appearance of coagulation failure will be evaluated and reported at the 1st day, once a week and last visit during patients' hospitalization.

  3. the Appearance of renal failure [ Time Frame: Up to 28 days ]
    The appearance of renal failure will be evaluated and reported at the 1st day, once a week and last visit during patients' hospitalization.

  4. the Appearance of circulative failure [ Time Frame: Up to 28 days ]
    The appearance of circulative failure will be evaluated and reported at the 1st day, once a week and last visit during patients' hospitalization.

  5. the Appearance of CNS failure [ Time Frame: Up to 28 days ]
    The appearance of respiratory failure will be evaluated and reported at the 1st day, once a week and last visit during patients' hospitalization.

  6. the Appearance of respiratory failure [ Time Frame: Up to 28 days ]
    The appearance of respiratory failure will be evaluated and reported at the 1st day, once a week and last visit during patients' hospitalization.

  7. Serum bilirubin [ Time Frame: Up to 28 days ]
    The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization.

  8. International Normalized Ratio(INR) [ Time Frame: Up to 28 days ]
    The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization.

  9. Serum creatinine [ Time Frame: Up to 28 days ]
    The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization.

  10. Aminotransferase [ Time Frame: Up to 28 days ]
    The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization.

  11. Alkaline phosphatase(AKP) [ Time Frame: Up to 28 days ]
    The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization.

  12. γ-Glutamyltransferase(γ-GT) [ Time Frame: Up to 28 days ]
    The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization.

  13. white blood cell count/neutrophil count [ Time Frame: Up to 28 days ]
    The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization.


Biospecimen Retention:   Samples With DNA
whole blood, serum


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 79 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
chronic liver disease patients(with liver dysfunction more than 6 months) with acute liver injury[with ALT>3 ULN),AST>3NL or TB>2 ULN within 1 week before enrollment] or acute decompensation[having ascites, hepatic encephalopathy, bacterial infection ,gastrointestinal bleeding or jaundice(TB > 5ULN)within 1 month before enrollment].
Criteria

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)>3ULN,AST(aspartate aminotransferase)>3ULN or TB(total bilirubin)>2 ULN 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].

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641872


Contacts
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Contact: Hai Li +86-13818525494 haili_17@126.cpm

Locations
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China, Beijing
Ditan Hospital of integrated traditional Chinese and Western Medicine Center Recruiting
Beijing, Beijing, China, 100015
Contact: Xianbo Wang, Professor    +86-13011001598    wangxianbo638@163.com   
China, Chongqing
Southwest Hospital of Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400038
Contact: Baoyan Xu, Professor    +86-13032396309    xby1977@126.com   
China, Guangdong
Southern hospital infection department Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Jinjun Chen, Professor    +86-13902246336    chjj@smu.edu.cn   
China, Henan
Henan Provincial People's Hospital Recruiting
Zhengzhou, Henan, China, 450003
Contact: Junping Liu, Professor         
China, Hubei
Taihe Hospital Recruiting
Shiyan, Hubei, China, 442000
Contact: Jizhong Meng, Professor    +86-18971905757    zhongji.meng@163.com   
Wuhan Union Hospital of Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Xin Zheng, Professor    +86-18602724981    xin11@hotmail.com   
China, Hunan
Xiangya hospital of Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Yan Huang, Professor    +86-13874854142    drhyan@163.com   
China, Jilin
The First Affiliated Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130021
Contact: Xiaoyu Wen, Professor    +86-15804301609    wenxiaoyu328@aliyun.com   
China, Shanghai
Renji hospital of Shanghai Jiao Tong University School of Medical Recruiting
Shanghai, Shanghai, China, 200001
Contact: Hai Li    +86-13818525494    haili_17@126.com   
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China, 200083
Contact: Zhiping Qian, Professor    +86-18916192210    qianzhiping@shaphc.org   
China, Xinjiang
Infectious Disease Center, The First Teaching Hospital of Xinjiang Medical University Recruiting
Ürümqi, Xinjiang, China, 830054
Contact: Xiaobo Lu, Professor       luxiaobo1101@sina.com   
China, Zhejiang
The First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Hai Li
Investigators
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Study Director: Hai Li Digestive Department of Renji Hospital,Shanghai Jiao Tong University School of Medicine

Publications:

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Responsible Party: Hai Li, Official Title: Professor, Department of Gastroenterology, RenJi Hospital ; Vice Director of the National Digestive Key Laboratory; Youth Commission of Chinese Society of Hepatology., Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03641872     History of Changes
Other Study ID Numbers: CHINA-ACLF-2
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hai Li, Shanghai Jiao Tong University School of Medicine:
acute-on-chronic liver disease
acute decompensation
multiple organ failures
acute-on-chronic liver failure

Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Diseases
Liver Failure, Acute
Acute-On-Chronic Liver Failure
Digestive System Diseases