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

Sponsor

University of L'Aquila (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05436860

Collaborator

(none)

20,189

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Steatosis	Device: liver ultrasound

Study Design

Study Type:

Observational

Anticipated Enrollment :

20189 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

Emergency room as a screening tool [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

Sequelae on daily life [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of L'Aquila

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clara Balsano, Full professor, University of L'Aquila

ClinicalTrials.gov Identifier:

NCT05436860

Other Study ID Numbers:

61615

First Posted:

Jun 29, 2022

Last Update Posted:

Jun 29, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fatty Liver

Emergencies

Study Results

No Results Posted as of Jun 29, 2022