NCT05869396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

4.5 years

First QC Date

April 25, 2023

Last Update Submit

May 18, 2023

Conditions

Perioperative MedicineHip FracturesEchocardiography

Keywords

ElderlyHip fracturePrognosisEchocardiography

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality

    through study completion, an average of 1 year]

Secondary Outcomes (1)

  • Relation between echocardiographic findings and survival

    through study completion, an average of 1 year]

Study Arms (2)

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

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).

Interventions

echocardiographyDIAGNOSTIC_TEST

Bedside echocardiography

echocardiogrpahy

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged \> 70 years with hip fragility fracture

You may qualify if:

  • hip fragility fracture,
  • age \> 70 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFlorence

Florence, 50136, Italy

Location

Related Publications (3)

  • 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.

    PMID: 34861226BACKGROUND

  • 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.

    PMID: 33947928BACKGROUND

  • 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.

    PMID: 35957924RESULT

MeSH Terms

Conditions

Hip Fractures

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Carlo Rostagno, MD,PhD

    University of Florence

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssociate Professor

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 22, 2023

Study Start

January 1, 2018

Primary Completion

June 30, 2022

Study Completion

December 31, 2022

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)