DeliriumNCT05105906
Post-operative Delirium (POD) in Patients Undergoing Hip Fracture Surgery
An observational study of Delirium and Cognitive Dysfunction, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The primary endpoint of the study is the appearance of Post Operative Delirium within the first 3 months. The secondary endpoints are the development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time (including rehabilitation performed within the… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Cognitive Dysfunction
- What is being tested?
- cognitive tests performed
- How many people
- 270 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All men and women over the age of 65 with clinical-radiological hip fracture presence will be enrolled
Who may be able to join
- Age > 65
- Clinical - radiological presence of hip fracture
Who cannot join
- Age <65
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-operative Delirium (POD) Assessment in Patients Undergoing Hip Fracture Surgery
The primary endpoint of the study is the appearance of Post Operative Delirium within the first 3 months.
The secondary endpoints are the development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time (including rehabilitation performed within the Polyclinic).. The analysis of the risk factors of POD and their correlation with the development of POCD/Dementia in the post-surgery period will provide important information for the optimization of the management path of these patients at an individual level , with inevitable repercussions on the possibility of reintegration into social and family life
- Conditions
- Delirium, Cognitive Dysfunction
- Being tested
- cognitive tests performed
- Medical subject headings
- Delirium, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive tests performedDiagnostic test
cognitive tests performed
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of POD within the first 3 months
Appearance of Post Operative Delirium within the first 3 months after hip surgery
Measured: 3 months assessment
Secondary outcomes (1)
Development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time
Development of Post Operative Cognitive Dysfunction, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time
Measured: 12 months assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 May 2021
- Primary completion25 May 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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-control
- Time perspective
- Other
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuliano Ferrone, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Giuliano Ferrone, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105906
- Sponsor's protocol ID
- FPG ID 3993
- Status last verified
- Mar 2025
- First submitted
- 29 Sep 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Delirium (POD) Assessment in Patients Undergoing Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT05105906
- Acronym / sponsor ID
- FPG ID 3993
- Conditions
- Delirium, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 3 Nov 2021 (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 primary endpoint of the study is the appearance of Post Operative Delirium within the first 3 months.
The secondary endpoints are the development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time (including rehabilitation performed within the Polyclinic).. The analysis of the risk factors of POD and their correlation with the development of POCD/Dementia in the post-surgery period will provide important information for the optimization of the management path of these patients at an individual level , with inevitable repercussions on the possibility of reintegration into social and family life
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All men and women over the age of 65 with clinical-radiological hip fracture presence will be enrolled
Key inclusion criteria (2 listed)
- Age > 65
- Clinical - radiological presence of hip fracture
Key exclusion criteria (1 listed)
- Age <65
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive tests performedcognitive tests performed | Diagnostic test | – |
Primary outcome
Appearance of POD within the first 3 months
Time frame: 3 months assessment
Appearance of Post Operative Delirium within the first 3 months after hip surgery
1 secondary outcome
Development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time
Time frame: 12 months assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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. This study is not recruiting at the moment.
Giuliano Ferrone principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Delirium and Cognitive Dysfunction, 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: finished, as of the sponsor's last update on 13 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearance of POD within the first 3 months (time frame: 3 months assessment). 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 13 Mar 2025.