PreDEA Study, Prevention in Emergency / Acceptance Departments: the Case of Hepatic Steatosis

Recruiting

• Conditions: Hepatic Steatosis
• Interventions: Device: liver ultrasound

• Registration Number: NCT05436860
• Lead Sponsor: University of L'Aquila

Brief Summary

Our study aims to evaluate whether the Emergency Department (PS) can support the health system to improve the prevention and management of chronic inflammatory diseases and ensure actions aimed at screening, raising awareness and informing the population.

Specifically, the determination of the prevalence of a widely diffused pathology such as fatty liver disease aims to be the precursor of future pilot studies aimed at evaluating the advantages and critical issues of the PS as a prevention tool.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-29
• Study Start: 2023-07-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-05
• Primary Completion: 2023-12-31
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20189

Inclusion Criteria

• Patients over 18
• Patients admitted to Emergency department in white or green code

Exclusion Criteria

• Patients under 18
• Patients admitted to Emergency department in yellow or red code

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
absence of hepatic hyperechogenicity on ultrasound evaluation	liver ultrasound	-
presence of hepatic hyperechogenicity on ultrasound evaluation	liver ultrasound	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the number of steatotic patients who access the emergency room - Emergency room as a tool for early diagnosis of hepatic steatosis	12 months	Evaluation of the effectiveness of the Emergency Department as a screening tool for the emergence of the submerged by measuring the prevalence, on the national territory, of hepatic steatosis in patients who access the emergency room.

Secondary Outcome Measures

Name	Time	Method
Develop new prognostic algorithms for assessing the risk of major and minor clinical events in patients with fatty liver.	36 months	Improve the approval rating of the service offered by the PS to the patient who has been assigned a white or green color code for triage.To develop new prognostic algorithms for assessing the risk of major and minor clinical events in patients with fatty liver.

Trial Locations

Locations (1)

Clara Balsano; 🇮🇹 L'Aquila, Italy/L'Aquila, Italy