Status:
NOT_YET_RECRUITING
Real-World Validation of a Prognostic Prediction Model for Patients With Acute Exacerbations of Chronic Liver Disease
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Chronic Liver Disease and Cirrhosis
Eligibility:
All Genders
18-75 years
Brief Summary
Our study is a multi-site, prospective, observational study including patients with acute exacerbations of CLD. Approximately 1500 patients from 24 hospitals in diverse regions in China will be enroll...
Detailed Description
The study is a multi-site, prospective, observational study conducted in 24 hospitals representing different regions across China. The choice of 24 hospitals was based on their representation of diver...
Eligibility Criteria
Inclusion
- Chronic liver disease with or without cirrhosis, including chronic viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, autoimmune liver disease, metabolic liver disease, chronic drug- induced liver disease and cryptogenic cirrhosis. The duration of underlying non-cirrhotic chronic liver disease should be longer than 6 months.
- Acute exacerbations of chronic liver disease, including acute decompensation (bacterial infection, hepatic encephalopathy, variceal bleeding, ascites and jaundice) in 1 month and liver injury (ALT or AST \>3 ULN , or TB\>2 ULN) in 1 week.
- Patients are informed of the study purpose and willing to sign the informed consent.
Exclusion
- \<18 years old or \>75 years old
- with malignancy of liver or other organs
- with other serious comorbidities (such as circulatory failure, respiratory failure, chronic kidney disease with end-stage renal failure, stroke within 6 months before admission, severe systemic autoimmune diseases or severe metabolic disease )
- pregnant
- receiving immunosuppressive agents for non-hepatic diseases
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06181448
Start Date
February 1 2024
End Date
January 31 2026
Last Update
December 26 2023
Active Locations (1)
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1
Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200120