Preoperative Echocardiography in Patients With Hip Fracture

Hip Fractures Clinical Trial

Official title:

Preoperative Echocardiography in Patients With Hip Fracture: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05869396
• Other study ID #: CRostagno
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• hip fragility fracture,

• age > 70 years

Exclusion Criteria:

• high energy fracture in aged > 70 years

• age < 70 years

Related Conditions & MeSH terms

• Echocardiography
• Fractures, Bone
• Hip Fractures

Intervention

Diagnostic Test:
• echocardiography
Bedside echocardiography

Locations

Country	Name	City	State
Italy	UFlorence	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality	through study completion, an average of 1 year]
Secondary	Relation between echocardiographic findings and survival	Relation between echocardiographic findings and survival	through study completion, an average of 1 year]