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

Hepatic Steatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05436860
• Other study ID #: 61615
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2023
• Source: University of L'Aquila
• Contact: Clara Balsano, MD
• Phone: +39 0862434774
• Email: clara.balsano[@]univaq.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20189
• Est. completion date: July 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Fatty Liver
• Hepatic Steatosis

Intervention

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.

Locations

Country	Name	City	State
Italy	Clara Balsano	L'Aquila	Italy/L'Aquila

Sponsors (1)

Lead Sponsor	Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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