Real-World Validation of a Prognostic Prediction Model for Patients With Acute Exacerbations of Chronic Liver Disease

Chronic Liver Disease and Cirrhosis Clinical Trial

Official title:

Real-World Validation of a Prognostic Prediction Model for Patients With Acute Exacerbations of Chronic Liver Disease: A Multi-Site, Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06181448
• Other study ID #: Catchlife-predicting
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: December 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Hai Li, MD
• Phone: +86-13818525494
• Email: haili_17[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 enrolled and followed for 3 months. Data about demographic data, laboratory tests, and clinical manifestations, collected through a mobile application, will inform real-time prognostic scores. The aim of this study is to validate the model's real-world applicability in non-specialist hospital settings.

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 diverse geographical regions across China. These hospitals were selected to ensure a comprehensive validation of the screening model's efficacy in varied healthcare settings. Data will be collected through a mobile application, providing real-time prognostic scores for patients. The study is divided into three parts: patient recruitment, in-hospital follow-up, and post-discharge follow-up . Follow-up will last for 3 months. Endpoints will be considered for all-cause death, survival and liver transplantation. The study is planned to enroll 1500 patients from January 2024 to January 2026.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• <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

Related Conditions & MeSH terms

• Chronic Liver Disease and Cirrhosis
• Liver Diseases

Locations

Country	Name	City	State
China	Renji Hospital,Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-Term Mortality	All cause mortality within 90 days after admission	3 months
Primary	Short-Term Liver Transplantation Rate	Liver transplantation rate within 90 days after admission	3 months