Trial of Focused Cardiac Ultrasound for Fractured Neck of Femur Surgery

NCT02629484 | Completed DMC

• 1 other identifier: 2015.231
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

Hip fracture surgery is a major world health care burden and concern, as it has a large and increasing prevalence and carries very high patient mortality, disability and community health care cost. As the commonest cause of mortality is from cardiac complications, and cardiac disease is prevalent and frequently missed by standard care, we hypothesise that earlier and more accurate diagnosis and treatment of cardiac pathology in this cohort will lead to improved outcome. Focused cardiac ultrasound (FCU) is a new increasingly popular technique used by doctors that enables earlier and more accurate diagnosis of cardiac disorders that can be performed routinely before hip fracture surgery. Our preliminary data of 64 patients demonstrated that routine FCU before surgery lead to a change in cardiac diagnosis and management in 50% of patients requiring hip fracture surgery, which was associated with a 50% reduction in mortality 12 months after surgery compared with controls. It is therefore important for a large randomised trial to be performed to confirm or rebuke these findings, as if true, would have a very large impact on health care and may also improve health care and outcome in other high-risk surgical populations. The proposed pilot study is a pilot study which aims to establish feasibility, safety, compliance and group separation prior to commencing a definitive multicentre trial.

Conditions

Hip Fractures

Keywords

echocardiography; hip fracture; surgery; outcomes

Outcome Measures

Primary Outcomes (1)

• Composite mortality and morbidity score

  The primary outcome is 30 day composite outcome of the incidence of mortality, acute kidney injury, and cardiovascular morbidity (including non-fatal myocardial infarction, stroke, pulmonary embolism or cardiac arrest.

  30 days after surgery

Secondary Outcomes (4)

• The number of days alive, out of hospital, and until return to place of origin

  12 months

• Changes in clinician diagnosis and management from a recorded preoperative plan

  30 days

• Total cost of care

  12 months

• EuroQol Health status score

  12 months

Study Arms (2)

Focused Cardiac Ultrasound

ACTIVE COMPARATOR

participants randomised to receive focused cardiac ultrasound prior to surgery for hip fracture

Other: Focused cardiac ultrasound

Standard care (clinical assessment)

NO INTERVENTION

Participants randomised to standard care receive clinical assessment of the patient

Interventions

Focused cardiac ultrasound OTHER

focused cardiac ultrasound is a goal-focused transthoracic echocardiography examination of the heart, aimed to improve the diagnostic accuracy of clinical assessment

Focused Cardiac Ultrasound

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with isolated, primary, non-metastatic fractured neck of femur, where surgery is expected within 48 hours after hospital admission will be recruited.

You may not qualify if:

• Patients with prior hip surgery on the affected side, or where the cause is likely to be due to metastatic cancer, or where survival is unlikely in the 24 hours from admission will not be included.

Sponsors & Collaborators

• University of Melbourne: lead
• Melbourne Health: collaborator
• Austin Health: collaborator

Study Sites (3)

Prince Charles Hospital

Brisbane, Queensland, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Western and Sunshine General hospitals

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Colin Royse, MD, BS

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesia

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 14, 2015
• Study Start: February 1, 2016
• Primary Completion: January 26, 2017
• Study Completion: January 26, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-04

Locations

AU (3)