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

NCT ID: NCT06181448

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Chronic Liver Disease and Cirrhosis

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hai Li

professor of department of gastroenterological division, Renji Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hai Li, MD

Role: STUDY_DIRECTOR

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

Locations

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Renji Hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Hai Li, MD

Role: CONTACT

Phone: +86-13818525494

Email: [email protected]

Facility Contacts

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Hai Li, MD

Role: primary

Other Identifiers

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Catchlife-predicting

Identifier Type: -

Identifier Source: org_study_id