Preoperative Echocardiography in Patients With Hip Fracture

Sponsor
University of Florence (Other)
Overall Status
Completed
CT.gov ID
NCT05869396
Collaborator
(none)
255
1
60
4.3

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: echocardiography

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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
255 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Preoperative Echocardiography in Patients With Hip Fracture: A Prospective Cohort Study
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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).

Diagnostic Test: echocardiography
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).

Outcome Measures

Primary Outcome Measures

  1. Mortality [through study completion, an average of 1 year]]

    Mortality

Secondary Outcome Measures

  1. Relation between echocardiographic findings and survival [through study completion, an average of 1 year]]

    Relation between echocardiographic findings and survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • hip fragility fracture,

  • age > 70 years

Exclusion Criteria:
  • high energy fracture in aged > 70 years

  • age < 70 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 UFlorence Firenze Italy 50136

Sponsors and Collaborators

  • University of Florence

Investigators

  • Principal Investigator: Carlo Rostagno, MD,PhD, University of Florence

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Carlo Rostagno, Asssociate Professor, University of Florence
ClinicalTrials.gov Identifier:
NCT05869396
Other Study ID Numbers:
  • CRostagno
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Carlo Rostagno, Asssociate Professor, University of Florence
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2023