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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02629484
Registration number
NCT02629484
Ethics application status
Date submitted
1/12/2015
Date registered
14/12/2015
Date last updated
2/05/2018
Titles & IDs
Public title
Trial of Focused Cardiac Ultrasound for Fractured Neck of Femur Surgery
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Scientific title
A Pilot Study to Assess Feasibility, Compliance, Safety and Group Separation for a Multicentre Randomised Trial of Preoperative Focused Cardiac Ultrasound for Fractured Neck of Femur Surgery
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Secondary ID [1]
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2015.231
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Universal Trial Number (UTN)
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Trial acronym
ECHONOFII
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip Fractures
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Focused cardiac ultrasound
Active comparator: Focused Cardiac Ultrasound - participants randomised to receive focused cardiac ultrasound prior to surgery for hip fracture
No intervention: Standard care (clinical assessment) - Participants randomised to standard care receive clinical assessment of the patient
Other interventions: Focused cardiac ultrasound
focused cardiac ultrasound is a goal-focused transthoracic echocardiography examination of the heart, aimed to improve the diagnostic accuracy of clinical assessment
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite mortality and morbidity score
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Assessment method [1]
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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.
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Timepoint [1]
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30 days after surgery
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Secondary outcome [1]
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The number of days alive, out of hospital, and until return to place of origin
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Assessment method [1]
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Longitudinal measures include the number of days alive, out of hospital and returning to their place of origin out to 12 months.
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Changes in clinician diagnosis and management from a recorded preoperative plan
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Assessment method [2]
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The treating doctors will complete a diagnosis and management research form prior to revealing the FCU findings or not. The actual management of the patient after allocation will be recorded prospectively for all patients, with the data recording sheets not showing allocation. Data include cardiac monitoring and treatment preoperatively, intraoperatively and postoperatively, including type of anaesthesia, fluid therapy, inotropes, other invasive organ support and intensive care use, surgical technique, and additional cardiovascular management post-hospital discharge.
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Timepoint [2]
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30 days
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Secondary outcome [3]
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Total cost of care
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Assessment method [3]
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Units of health care resources consumed will be combined with Australian unit costs derived from Pharmaceutical benefit schedule, Medicare and Australian Diagnostic group indicators. The dollar value for each component of stay (e.g. days in hospital, drugs used, investigations performed) will be converted into a cost value and aggregated to make a single cost over the 12 month follow up period
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Timepoint [3]
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12 months
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Secondary outcome [4]
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EuroQol Health status score
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Assessment method [4]
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The EuroQol health status survey instrument is a a standard, internationally validated instrument with Australian population norms, will be conducted at 12 months follow up
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Timepoint [4]
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12 months
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Eligibility
Key inclusion criteria
* Patients presenting with isolated, primary, non-metastatic fractured neck of femur, where surgery is expected within 48 hours after hospital admission will be recruited.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/01/2018
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Prince Charles Hospital - Brisbane
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Recruitment hospital [2]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [3]
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Western and Sunshine General hospitals - Melbourne
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Recruitment postcode(s) [1]
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- Brisbane
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Recruitment postcode(s) [2]
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3050 - Melbourne
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Recruitment postcode(s) [3]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Melbourne Health
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Address [1]
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Country [1]
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Other collaborator category [2]
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Government body
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Name [2]
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Austin Health
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02629484
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Colin Royse, MD, BS
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02629484
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