Preoperative Echocardiography in Patients With Hip Fracture

NCT ID: NCT05869396

Last Updated: 2023-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Perioperative Medicine Hip Fractures Echocardiography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

echocardiography

Intervention Type DIAGNOSTIC_TEST

Bedside 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).

No interventions assigned to this group

Interventions

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echocardiography

Bedside echocardiography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* hip fragility fracture,
* age \> 70 years

Exclusion Criteria

* high energy fracture in aged \> 70 years
* age \< 70 years
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florence

OTHER

Sponsor Role lead

Responsible Party

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Carlo Rostagno

Asssociate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlo Rostagno, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florence

Locations

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UFlorence

Florence, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 34861226 (View on PubMed)

Rostagno 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.

Reference Type BACKGROUND
PMID: 33947928 (View on PubMed)

Rostagno 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.

Reference Type RESULT
PMID: 35957924 (View on PubMed)

Other Identifiers

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CRostagno

Identifier Type: -

Identifier Source: org_study_id

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