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

NCT06181448 | Unknown

• 1 other identifier: Catchlife-predicting
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease and Cirrhosis

Keywords

Acute-on-chronic liver failure; Prognostic prediction model; Real-world validation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Hospitalized patients with acute exacerbations of chronic liver disease

1. Patient data will be collected through a mobile application, providing real-time prognostic scores for patients. 2. Standary therapy for chronic liver disease with ALI and/or AD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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\[having ascites, hepatic encephalopathy, bacterial infection ,gastrointestinal bleeding or jaundice(TB \> 5ULN)within 1 month before enrollment\].

You may qualify if:

• 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.

You may not qualify if:

• \<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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Fibrosis; Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Hai Li, MD

  Digestive Department of Renji Hospital,Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Hai Li, MD

CONTACT

+86-13818525494; haili_17@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of department of gastroenterological division, Renji Hospital

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: February 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

CN (1)