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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatic Steatosis
• Intervention / Treatment: Device: liver ultrasound

• Study Type: Observational
• Enrollment (Estimated): 20189

Contacts and Locations

• Study Contact: Name: Clara Balsano, MD; Phone Number: +39 0862434774; Email: clara.balsano@univaq.it

Study Locations

• Italy
  • Italy/L'Aquila
    • L'Aquila, Italy/L'Aquila, Italy, 67100
      • Recruiting
      • Clara Balsano
      • Contact: Clara Balsano; Phone Number: +390862434774; Email: clara.balsano@univaq.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
presence of hepatic hyperechogenicity on ultrasound evaluation	Device: liver ultrasound; At the time of access to the emergency room, a cohort of male and female patients aged 18 or over will be consecutively recruited with green or white color coded triage. patients who agree to participate in the study will undergo liver ultrasound. Patients who test negative on ultrasound evaluation for liver hyperechogenicity will be part of the control group.
absence of hepatic hyperechogenicity on ultrasound evaluation	Device: liver ultrasound; At the time of access to the emergency room, a cohort of male and female patients aged 18 or over will be consecutively recruited with green or white color coded triage. patients who agree to participate in the study will undergo liver ultrasound. Patients who test negative on ultrasound evaluation for liver hyperechogenicity will be part of the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the number of steatotic patients who access the emergency room - Emergency room as a tool for early diagnosis of hepatic steatosis	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop new prognostic algorithms for assessing the risk of major and minor clinical events in patients with fatty liver.	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.	36 months

Collaborators and Investigators

• Sponsor: University of L'Aquila

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Liver Diseases; Emergencies; Fatty Liver
• Other Study ID Numbers: 61615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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