Liver Dysfunction Clinical Trial
— Ch-CANONIC-ValOfficial title:
A Prospective Multi-center Validating Cohort for ACLF Diagnosis and Prognosis From Ch-CANONIC Study
Verified date | October 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. 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.
Status | Completed |
Enrollment | 1370 |
Est. completion date | July 31, 2020 |
Est. primary completion date | April 21, 2020 |
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)>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 |
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 | Southern hospital infection department | Guangzhou | Guangdong |
China | The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
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 | Infectious Disease Center, 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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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short-Term Mortality & | Mortality will be calculated and reported at 28 days,90 days. | Up to 3 months | |
Primary | Short-Term Liver Transplantation Rate | 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. | Up to 3 months | |
Secondary | the Appearance of liver failure | The appearance of liver failure will be evaluated and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days | |
Secondary | the Appearance of coagulation failure | The appearance of coagulation failure will be evaluated and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days | |
Secondary | the Appearance of renal failure | The appearance of renal failure will be evaluated and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days | |
Secondary | the Appearance of circulative failure | The appearance of circulative failure will be evaluated and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days | |
Secondary | the Appearance of CNS failure | The appearance of respiratory failure will be evaluated and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days | |
Secondary | the Appearance of respiratory failure | The appearance of respiratory failure will be evaluated and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days | |
Secondary | Serum bilirubin | The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days | |
Secondary | International Normalized Ratio(INR) | The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days | |
Secondary | Serum creatinine | The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days | |
Secondary | Aminotransferase | The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days | |
Secondary | Alkaline phosphatase(AKP) | The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days | |
Secondary | ?-Glutamyltransferase(?-GT) | The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days | |
Secondary | white blood cell count/neutrophil count | The biochemical parameter will be collected and reported at the 1st day, once a week and last visit during patients' hospitalization. | Up to 28 days |
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