Clinical trial NCT06181448: Real-World Validation of a Prognostic Prediction Model for Patients With Acute Exacerbations of Chronic Liver Disease
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Liver Disease and Cirrhosis
Keywords: Acute-on-chronic liver failure
Prognostic prediction model
Real-world validation
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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\[having ascites, hepatic encephalopathy, bacterial infection ,gastrointestinal bleeding or jaundice(TB \> 5ULN)within 1 month before enrollment\].

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Short-Term Mortality
timeFrame: 3 months
measure: Short-Term Liver Transplantation Rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital,Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Digestive Department of Renji Hospital,Shanghai Jiao Tong University School of Medicine
name: Hai Li, MD
role: STUDY_DIRECTOR
References: