EmergenciesSADENCT05593692
Gender Differences and Age Related Differences in Emergency Department Admission
An observational study of Emergencies and Gender, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The goal of this observational study is to learn about difference related to age and gender in patients admitted to emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies, Gender, Age Problem
- How many people
- 15,000 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2022to 28 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to ED
Who may be able to join
- Age over 18 y
- Admitted to emergency department
Who cannot join
- Age under 18 y
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Davide Della Polla contact
Italy1 site, 1 recruiting
- Recruiting
IRCSS Fondazione Policlinico Agostino Gemelli
Rome, Lazio, 00136
Marcello Covino, 00390630153188, marcello.covino@policlinicogemelli.it
About this study
The goal of this observational study is to learn about difference related to age and gender in patients admitted to emergency department.
Read the 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
- Conditions
- Emergencies, Gender, Age Problem
- Keywords
- sex, gender, age, emergency department
- Medical subject headings
- Emergencies, Coitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death
Measured: 30 days
Secondary outcomes (1)
length of stay
length of stay
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start18 Oct 2022
- Primary completion5 Jul 2025 (estimated)
- Study completion28 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593692
- Sponsor's protocol ID
- 5121
- Acronym
- SADE
- Status last verified
- Feb 2025
- First submitted
- 20 Oct 2022
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences and Age Related Differences in Emergency Department Admission
- ClinicalTrials.gov ID
- NCT05593692
- Acronym / sponsor ID
- SADE / 5121
- Conditions
- Emergencies, Gender, Age Problem
- Keywords
- sex, gender, age, emergency department
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 5 Jul 2025 (estimated)
- Study completion
- 28 Oct 2025 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to ED
Key inclusion criteria (2 listed)
- Age over 18 y
- Admitted to emergency department
Key exclusion criteria (1 listed)
- Age under 18 y
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: 30 days
Death
1 secondary outcome
length of stay
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Davide Della Polla contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies and Gender, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcello Covino (00390630153188, marcello.covino@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.