Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000164897
Ethics application status
Approved
Date submitted
19/01/2021
Date registered
17/02/2021
Date last updated
17/02/2021
Date data sharing statement initially provided
17/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does preoperative muscle mass predict outcomes after heart and/or lung transplantation
Scientific title
Preoperative assessment of muscle mass and heart rate variability as predictors of outcome in patients undergoing heart and/or lung transplantation
Secondary ID [1] 303207 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart transplantation 320347 0
Lung transplantation 320348 0
Sarcopenia 320349 0
Condition category
Condition code
Surgery 318260 318260 0 0
Other surgery
Musculoskeletal 318609 318609 0 0
Other muscular and skeletal disorders

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 outpatient clinic prior to surgery. The ultrasound takes less than 5 minutes and will be performed by an anaesthetist who is part of the research team. A 5 minute electrocardiograph (ECG) recording will also be performed for subsequent analysis
Intervention code [1] 319515 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326243 0
Hospital Length of Stay - assessed using the hospital electronic medical record
Timepoint [1] 326243 0
Discharge from hospital
Secondary outcome [1] 390705 0
Length of Stay in ICU - assessed using the hospital electronic medical record
Timepoint [1] 390705 0
Discharge from ICU
Secondary outcome [2] 390706 0
In-hospital Mortality - assessed using the hospital electronic medical record
Timepoint [2] 390706 0
Date of death in hospital

Eligibility
Key inclusion criteria
All patients undergoing heart and/or lung transplantation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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
1/05/2021
Actual
Date of last participant enrolment
Anticipated
30/04/2023
Actual
Date of last data collection
Anticipated
30/05/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307611 0
Hospital
Name [1] 307611 0
Department of Anaesthesia, St Vincent’s Hospital
Country [1] 307611 0
Australia
Primary sponsor type
Hospital
Name
St Vincent’s Hospital
Address
390 Victoria St,
Darlinghurst,
NSW 2010
Country
Australia
Secondary sponsor category [1] 308302 0
None
Name [1] 308302 0
Address [1] 308302 0
Country [1] 308302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307663 0
St Vincent’s Hospital Human Research & Ethics Committee
Ethics committee address [1] 307663 0
St Vincent’s Hospital
390 Victoria St
Darlinghurst
NSW 2010
Ethics committee country [1] 307663 0
Australia
Date submitted for ethics approval [1] 307663 0
Approval date [1] 307663 0
21/12/2020
Ethics approval number [1] 307663 0

Summary
Brief summary
Heart and/or lung transplantation is performed in patients with significant co-morbidities and burden of disease. Their peri-operative period is high risk and recovery may be prolonged due to the risk of complications. There is considerable effort applied to appropriate risk stratification and selection of these patients prior to listing for transplantation.

Recently sarcopenia has been used as a surrogate for frailty. Patients undergoing heart and/or lung transplant surgery may be particularly susceptible to the risks associated with frailty. In heart/lung transplant 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 and/or reduced heart rate variability 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 108050 0
Dr Catherine Ashes
Address 108050 0
Department of Anaesthesia
St Vincent’s Hospital
390 Victoria Road
Darlinghurst
NSW 2010
Country 108050 0
Australia
Phone 108050 0
+61 2 83823200
Fax 108050 0
Email 108050 0
[email protected]
Contact person for public queries
Name 108051 0
Catherine Ashes
Address 108051 0
Department of Anaesthesia
St Vincent’s Hospital
390 Victoria Road
Darlinghurst
NSW 2010
Country 108051 0
Australia
Phone 108051 0
+61 2 83823200
Fax 108051 0
Email 108051 0
[email protected]
Contact person for scientific queries
Name 108052 0
Catherine Ashes
Address 108052 0
Department of Anaesthesia
St Vincent’s Hospital
390 Victoria Road
Darlinghurst
NSW 2010
Country 108052 0
Australia
Phone 108052 0
+61 2 83823200
Fax 108052 0
Email 108052 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. Even though the data will be de-identified, demographic and background health data will potentially allow individual identification of patients. Ie heart transplantation is uncommon and knowing the age and gender of a patient who received a heart transplant in any given year may allow identification of that patient. Only pooled data de-identified data will be released via publication as approved by our research and ethics committee


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.