Gender Differences and Age Related Differences in Emergen... | NCT05593692

Studies
Gender Differences and Age Related Differences in Emergency Department Admission

NCT05593692

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Recruiting

Last Update Posted

Mar 5, 2025Actual

Enrollment

15,000Estimated

Phase

Not provided

Conditions

Emergencies
Gender
Age Problem

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 18, 2022Actual

Primary Completion Date

Jul 5, 2025Estimated

Completion Date

Oct 28, 2025Estimated

First Submitted Date

Oct 20, 2022

First Submission Date that Met QC Criteria

Oct 20, 2022

First Posted Date

Oct 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2025

Last Update Posted Date

Mar 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn about difference related to age and gender in patients admitted to emergency department.

Detailed Description

Objectives: Medicine is progressively becoming aware of the clinical difference among patients who present different age, gender, and comorbidities. Our goal is to examine how often different groups of patients access the Emergency Department and for which causes, as well as their different hospitalization and death rates.

Materials and methods: The investigators will collect and analyze data from all patients evaluated at the emergency department of "Fondazione Policlinico Agostino Gemelli" and "Istituto Clinico Humanitas di Milano" from January 2014 to December 2023, the sample obtained will be divided into four groups: younger than 50 years old, 50-65 years old, 66.75 years old, older than 75; each of these groups is divided between males, females and people who do not identify with either of those genders

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Death	Death	30 days

Secondary Outcomes

Measure	Description	Time Frame
length of stay	length of stay	180 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 18 y
Admitted to emergency department

Exclusion Criteria:

Age under 18 y

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients admitted to ED

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marcello Covino	Contact	00390630153188		marcello.covino@policlinicogemelli.it
Davide Della Polla	Contact			davideantonio.dellapolla@policlinicogemelli.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCSS Fondazione Policlinico Agostino Gemelli	Recruiting	Rome	Lazio	00136	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies
D003075	Coitus

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012725	Sexual Behavior

Browse Leaves

Not provided

Browse Branches

Not provided