Perioperative MedicineNCT05869396
Preoperative Echocardiography in Patients With Hip Fracture
An observational study of Perioperative Medicine and Hip Fractures, run by University of Florence at 1 site in Italy.
Trial summary
Aim of the study was to assess whether preoperative echocardiography affects time to surgery, length of hospital stay and in hospital mortality in patients undergoing hip fracture surgery. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Perioperative Medicine, Hip Fractures, Echocardiography
- What is being tested?
- echocardiography
- How many people
- 255 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 31 Dec 2022
- How long will I take part?
- 12 Months
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged > 70 years with hip fragility fracture
Who may be able to join
- hip fragility fracture,
- age > 70 years
Who cannot join
- high energy fracture in aged > 70 years
- age < 70 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Echocardiography in Patients With Hip Fracture: A Prospective Cohort Study
Aim of the study was to assess whether preoperative echocardiography affects time to surgery, length of hospital stay and in hospital mortality in patients undergoing hip fracture surgery. In the study entered two hundred fifty -five consecutive patients with hip fracture referred to a multidisciplinary hip fracture unit at a tertiary teaching hospital. Other 717 patients referred before implementation of routine echocardiographic examination were considered as control group. Echocardiography was performed in patients with systolic murmurs, unstable clinical conditions, recent decompensation of heart failure or hospital admission for coronary disease. Time to surgery, length of hospital stay (LOS) and in hospital mortality in patients underwent preoperative echocardiography (high risk group) were compared with patients who did not undergo echo (low-risk group ) and with an historical group.
Read the detailed description
The study is part of a project of Italian Health Ministry and Toscana Region -Regional Fund -2010-2316600- and was approved by Ethical Committee of Regione Toscana. Written informed consent to treatment and collection of clinical data for research purposes was obtained at admission. The study, was conducted according to STROBE statements and performed in line with the principles of the Declaration of Helsinki.
Between Jan 1 and May 31 2018 255 consecutive patients with hip fracture aged > 70 years were referred to the Hip fracture Unit of a teaching hospital . The diagnosis of hip fracture was made according to Orthopaedic Trauma Association classification . All patients were evaluated by multidisciplinary hip fracture team according to a previously described protocol. Demographic data, comorbidities and functional status before trauma were recorded. According to local evaluation protocol echocardiography was performed in patients with previously unknown systolic murmurs, unstable cardiovascular clinical conditions, recent (within 6 months) decompensation of heart failure or hospital admission for coronary disease (high-risk group). Results were compared with patients without these characteristics, in whom echocardiography was not performed (low-risk group). Patients referred to hip fracture Unit in 2016 before implementation of echocardiography protocol were considered as control group.
- Conditions
- Perioperative Medicine, Hip Fractures, Echocardiography
- Being tested
- echocardiography
- Keywords
- Elderly, Hip fracture, Prognosis, Echocardiography
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDiagnostic test
Bedside echocardiography
| Study group | Role | What they receive |
|---|---|---|
| echocardiogrpahy | Patients with with previously unknown systolic murmurs, unstable cardiovascular clinical conditions, recent (within 6 months) de-compensation of heart failure or hospital admission for coronary disease (high-risk group). Receives: Diagnostic Test: echocardiography | |
| non echocardiography | Patients without previously unknown systolic murmurs, unstable cardiovascular clinical conditions, recent (within 6 months) de-compensation of heart failure or hospital admission for coronary disease (low-risk group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality
Measured: through study completion, an average of 1 year]
Secondary outcomes (1)
Relation between echocardiographic findings and survival
Relation between echocardiographic findings and survival
Measured: through study completion, an average of 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Jan 2018
- Primary completion30 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perioperative MedicineStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Rostagno, University of Florence
- Investigators
- Carlo Rostagno, MD,PhD, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869396
- Sponsor's protocol ID
- CRostagno
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cartei A, Mossello E, Ceccofiglio A, Rubbieri G, Polidori G, Ranalli C, Cammilli A, Curcio M, Cavallini MC, Mannarino GM, Ungar A, Toccafondi G, Peris A, Marchionni N, Rostagno C. Independent, Differential Effects of Delirium on Disability and Mortality Risk After Hip Fracture. J Am Med Dir Assoc. 2022 Apr;23(4):654-659.e1. doi: 10.1016/j.jamda.2021.10.021. Epub 2021 Nov 30.
PubMed 34861226Rostagno C, Cartei A, Polidori G, Civinini R, Ceccofiglio A, Rubbieri G, Curcio M, Boccaccini A, Peris A, Prisco D. Management of ongoing direct anticoagulant treatment in patients with hip fracture. Sci Rep. 2021 May 4;11(1):9467. doi: 10.1038/s41598-021-89077-8.
PubMed 33947928Rostagno C, Cartei A, Rubbieri G, Ceccofiglio A, Civinini R, Curcio M, Polidori G, Boccaccini A. Hip Fracture Surgery in Severe Aortic Stenosis: A Study of Factors Affecting Mortality. Clin Interv Aging. 2022 Aug 4;17:1163-1171. doi: 10.2147/CIA.S360538. eCollection 2022.
PubMed 35957924
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Echocardiography in Patients With Hip Fracture: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05869396
- Acronym / sponsor ID
- CRostagno
- Conditions
- Perioperative Medicine, Hip Fractures, Echocardiography
- Keywords
- Elderly, Hip fracture, Prognosis, Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 May 2023 (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.
Aim of the study was to assess whether preoperative echocardiography affects time to surgery, length of hospital stay and in hospital mortality in patients undergoing hip fracture surgery. In the study entered two hundred fifty -five consecutive patients with hip fracture referred to a multidisciplinary hip fracture unit at a tertiary teaching hospital. Other 717 patients referred before implementation of routine echocardiographic examination were considered as control group. Echocardiography was performed in patients with systolic murmurs, unstable clinical conditions, recent decompensation of heart failure or hospital admission for coronary disease. Time to surgery, length of hospital stay (LOS) and in hospital mortality in patients underwent preoperative echocardiography (high risk group) were compared with patients who did not undergo echo (low-risk group ) and with an historical group.
Detailed description
The study is part of a project of Italian Health Ministry and Toscana Region -Regional Fund -2010-2316600- and was approved by Ethical Committee of Regione Toscana. Written informed consent to treatment and collection of clinical data for research purposes was obtained at admission. The study, was conducted according to STROBE statements and performed in line with the principles of the Declaration of Helsinki.
Between Jan 1 and May 31 2018 255 consecutive patients with hip fracture aged > 70 years were referred to the Hip fracture Unit of a teaching hospital . The diagnosis of hip fracture was made according to Orthopaedic Trauma Association classification . All patients were evaluated by multidisciplinary hip fracture team according to a previously described protocol. Demographic data, comorbidities and functional status before trauma were recorded. According to local evaluation protocol echocardiography was performed in patients with previously unknown systolic murmurs, unstable cardiovascular clinical conditions, recent (within 6 months) decompensation of heart failure or hospital admission for coronary disease (high-risk group). Results were compared with patients without these characteristics, in whom echocardiography was not performed (low-risk group). Patients referred to hip fracture Unit in 2016 before implementation of echocardiography protocol were considered as control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| echocardiogrpahy | – | Diagnostic Test: echocardiographyPatients with with previously unknown systolic murmurs, unstable cardiovascular clinical conditions, recent (within 6 months) de-compensation of heart failure or hospital admission for coronary disease (high-risk group). |
| non echocardiography | – | –Patients without previously unknown systolic murmurs, unstable cardiovascular clinical conditions, recent (within 6 months) de-compensation of heart failure or hospital admission for coronary disease (low-risk group). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged > 70 years with hip fragility fracture
Key inclusion criteria (2 listed)
- hip fragility fracture,
- age > 70 years
Key exclusion criteria (2 listed)
- high energy fracture in aged > 70 years
- age < 70 years
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 |
|---|---|---|
| echocardiographyBedside echocardiography | Diagnostic test | echocardiogrpahy |
Primary outcome
Mortality
Time frame: through study completion, an average of 1 year]
Mortality
1 secondary outcome
Relation between echocardiographic findings and survival
Time frame: through study completion, an average of 1 year]
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 22 May 2023.
- Background: PubMed 34861226Cartei A, Mossello E, Ceccofiglio A, Rubbieri G, Polidori G, Ranalli C, Cammilli A, Curcio M, Cavallini MC, Mannarino GM, Ungar A, Toccafondi G, Peris A, Marchionni N, Rostagno C. Independent, Differential Effects of Delirium on Disability and Mortality Risk After Hip Fracture. J Am Med Dir Assoc. 2022 Apr;23(4):654-659.e1. doi: 10.1016/j.jamda.2021.10.021. Epub 2021 Nov 30.
- Background: PubMed 33947928Rostagno C, Cartei A, Polidori G, Civinini R, Ceccofiglio A, Rubbieri G, Curcio M, Boccaccini A, Peris A, Prisco D. Management of ongoing direct anticoagulant treatment in patients with hip fracture. Sci Rep. 2021 May 4;11(1):9467. doi: 10.1038/s41598-021-89077-8.
- Results publication: PubMed 35957924Rostagno C, Cartei A, Rubbieri G, Ceccofiglio A, Civinini R, Curcio M, Polidori G, Boccaccini A. Hip Fracture Surgery in Severe Aortic Stenosis: A Study of Factors Affecting Mortality. Clin Interv Aging. 2022 Aug 4;17:1163-1171. doi: 10.2147/CIA.S360538. eCollection 2022.
- 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. This study is not recruiting at the moment.
Carlo Rostagno, MD,PhD principal investigator
University of Florence
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 Perioperative Medicine and Hip Fractures, run by University of Florence 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 2 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 22 May 2023. 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?
Mortality (time frame: through study completion, an average of 1 year]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05869396, which also lists 3 linked publications.
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 22 May 2023.