Preoperative Echocardiography in Patients With Hip Fracture

May 18, 2023 updated by: Carlo Rostagno, University of Florence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Firenze, Italy, 50136
        • UFlorence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged > 70 years with hip fragility fracture

Description

Inclusion Criteria:

  • hip fragility fracture,
  • age > 70 years

Exclusion Criteria:

  • high energy fracture in aged > 70 years
  • age < 70 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: through study completion, an average of 1 year]
Mortality
through study completion, an average of 1 year]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation between echocardiographic findings and survival
Time Frame: through study completion, an average of 1 year]
Relation between echocardiographic findings and survival
through study completion, an average of 1 year]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florence

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRostagno

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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