Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000678998
Ethics application status
Approved
Date submitted
18/05/2020
Date registered
15/06/2020
Date last updated
15/06/2020
Date data sharing statement initially provided
15/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound measurement of thigh muscle size as a predictor of outcomes after Cardio-Thoracic Surgery
Scientific title
Ultrasound measurement of the Rectus Femoris to predict outcomes after Cardiot-Thoracic Surgery
Secondary ID [1] 301315 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiothoracic Surgery 317498 0
Sarcopenia 317499 0
Frailty 317500 0
Condition category
Condition code
Surgery 315599 315599 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The rectus femoris muscle will be measured using ultrasound. This will occur in the anaesthetic bay prior to surgery or at the time of surgical booking in the pre-admission clinic
Intervention code [1] 317612 0
Early Detection / Screening
Comparator / control treatment
No control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323838 0
Hospital Length of Stay - assessed using the hospital electronic medical record
Timepoint [1] 323838 0
Discharge from Hospital
Secondary outcome [1] 383030 0
Length of Stay in ICU - assessed using the hospital electronic medical record
Timepoint [1] 383030 0
Discharge from ICU
Secondary outcome [2] 383031 0
In-hospital Mortality - assessed using the hospital electronic medical record
Timepoint [2] 383031 0
Date of death in hospital
Secondary outcome [3] 383032 0
Length of mechanical ventilation - this will be determined from the intensive care electronic medical record
Timepoint [3] 383032 0
Time of extubation

Eligibility
Key inclusion criteria
All patients undergoing Cardiothoracic Surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give consent
Emergency Surgery

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2020
Actual
Date of last participant enrolment
Anticipated
31/05/2021
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305752 0
Hospital
Name [1] 305752 0
Department of Anaesthesia, St Vincent’s Hospital, Sydney
Country [1] 305752 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria St,
Darlinghurst,
NSW 2010
Country
Australia
Secondary sponsor category [1] 306301 0
None
Name [1] 306301 0
Address [1] 306301 0
Country [1] 306301 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306026 0
Human Research and Ethics Committie
Ethics committee address [1] 306026 0
St Vincent's Hospital
390 Victoria Street,
Darlinghurst
NSW 2010
Ethics committee country [1] 306026 0
Australia
Date submitted for ethics approval [1] 306026 0
Approval date [1] 306026 0
14/02/2020
Ethics approval number [1] 306026 0

Summary
Brief summary
Recently sarcopenia has been used as a surrogate for frailty. Patients undergoing cardio-thoracic surgery may be particularly susceptible to the risks associated with frailty. In cardiothoracic surgical patients objective measurements of sarcopenia has been difficult and not fully investigated.

The hypothesis of this study is that reduced cross sectional area of the rectus femoris muscles as assessed by ultrasound will be associated with poorer outcomes amongst cardio-thoracic patients undergoing major surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102466 0
Dr Erez Ben-Menachem
Address 102466 0
Department of Anaesthesia
St Vincent's Hospital
390 Victoria Road,
Darlinghurst,
NSW 2010
Country 102466 0
Australia
Phone 102466 0
+61 2 8382 3200
Fax 102466 0
Email 102466 0
[email protected]
Contact person for public queries
Name 102467 0
Dr Erez Ben-Menachem
Address 102467 0
Department of Anaesthesia
St Vincent's Hospital
390 Victoria Road,
Darlinghurst,
NSW 2010
Country 102467 0
Australia
Phone 102467 0
+61 2 8382 3200
Fax 102467 0
Email 102467 0
[email protected]
Contact person for scientific queries
Name 102468 0
Dr Erez Ben-Menachem
Address 102468 0
Department of Anaesthesia
St Vincent's Hospital
390 Victoria Road,
Darlinghurst,
NSW 2010
Country 102468 0
Australia
Phone 102468 0
+61 2 8382 3200
Fax 102468 0
Email 102468 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be shared due to the risk of patients undergoing rare surgery subsequently being able to be indentified. ie heart transplant recipients


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.