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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Liver Disease and Cirrhosis

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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Hai Li, MD; Phone Number: +86-13818525494; Email: haili_17@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Renji Hospital,Shanghai Jiao Tong University School of Medicine
      • Contact: Hai Li, MD; Phone Number: 86 13818525494; Email: haili_17@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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].

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hospitalized patients with acute exacerbations of chronic liver disease; Patient data will be collected through a mobile application, providing real-time prognostic scores for patients.; Standary therapy for chronic liver disease with ALI and/or AD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-Term Mortality	All cause mortality within 90 days after admission	3 months
Short-Term Liver Transplantation Rate	Liver transplantation rate within 90 days after admission	3 months

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Study Director: Hai Li, MD, Digestive Department of Renji Hospital,Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Acute-on-chronic liver failure; Prognostic prediction model; Real-world validation
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: Catchlife-predicting

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No