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

NCT05436860 | Unknown

• 1 other identifier: 61615
• Study Type: observational
• Target: 20,189
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Steatosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Develop new prognostic algorithms for assessing the risk of major and minor clinical events in patients with fatty liver.

  36 months

Study Arms (2)

presence of hepatic hyperechogenicity on ultrasound evaluation

Device: liver ultrasound

absence of hepatic hyperechogenicity on ultrasound evaluation

Device: liver ultrasound

Interventions

liver ultrasound DEVICE

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; presence of hepatic hyperechogenicity on ultrasound evaluation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (1)

Clara Balsano

L’Aquila, Italy/L'Aquila, 67100, Italy

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Central Study Contacts

Clara Balsano, MD

CONTACT

+39 0862434774; clara.balsano@univaq.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: July 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)