Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000876099
Ethics application status
Approved
Date submitted
15/10/2010
Date registered
19/10/2010
Date last updated
14/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Defining the optimal dose for remote ischaemic preconditioning in adult patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass: a randomised controlled trial
Scientific title
A Randomised Controlled Trial in Adult Patients Undergoing Coronary Artery Bypass Graft Surgery Designed to Determine the Optimal Dose for Remote Ischaemic Preconditioning Compared to No Remote Ischaemic Preconditioning and Measuring the Primary Outcome of Area Under the Curve for Troponin to 72 hours Post Aortic Cross Clamp Removal.
Secondary ID [1] 252883 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Bypass Graft Surgery 258415 0
Condition category
Condition code
Cardiovascular 258582 258582 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inflation of a pneumatic tourniquet device on an upper limb for one, two or three periods of five minute at a time to induce remote ischaemic preconditioning (assignment to control, one, two or three cuff inflations will be by randomisation using a computer generated list of random numbers). Each period of inflation involves inflation to a pressure of 200mmHg for five minutes and is followed by five minutes of deflation.
Intervention code [1] 257410 0
Treatment: Other
Intervention code [2] 257423 0
Treatment: Devices
Comparator / control treatment
No blood pressure cuff inflation (Note this is a Dose Comparison but a dose of zero will be used). For the control, a blood pressure cuff will be placed on the upper limb but will not be inflated.
Control group
Dose comparison

Outcomes
Primary outcome [1] 259425 0
Defining the optimal dose of remote ishaemic preconditioning by determining which number of cycles generates the smallest area under the curve of high sensitivity troponin
Timepoint [1] 259425 0
6, 12, 24, 48 and 72 hours post removal of the aortic cross clamp at the end of cardiopulmonary bypass
Secondary outcome [1] 265974 0
Treatment success measured by ICU-free hours to 48 hours after ICU admission
Timepoint [1] 265974 0
48 hours after ICU admission

Eligibility
Key inclusion criteria
Undergoing coronary artery bypass graft surgery with cardiopulmonary bypass
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. documented ejection fraction <50%,
2. concurrent valvular surgery,
3. myocardial infarction within 21 days,
4. possible radial artery harvesting,
5. planned cross-clamp fibrillation,
6. >85 years of age,
7. peripheral vascular disease affecting the upper limbs
8. taking the sulphonylurea glibenclamide

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients will be approached the day prior to planned coronary artery surgery and will be randomly assigned to control of one of three escalating doses of remote ischaemic preconditioning. Allocation will be concealed from subjects as they will be under general anaesthesia at the time of intervention; however, the trial will not otherwise be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation 1:1:1:1 using a computer generated random number sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 2974 0
New Zealand
State/province [1] 2974 0

Funding & Sponsors
Funding source category [1] 257851 0
Government body
Name [1] 257851 0
Health Research Council of New Zealand
Country [1] 257851 0
New Zealand
Primary sponsor type
Other
Name
Medical Research Institute of New Zealand
Address
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
New Zealand
Country
New Zealand
Secondary sponsor category [1] 257057 0
Hospital
Name [1] 257057 0
Wellington Regional Hospital
Address [1] 257057 0
Wellington Hospital
Private Bag 7902
Wellington South
Country [1] 257057 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259886 0
Ethics committee address [1] 259886 0
Ethics committee country [1] 259886 0
Date submitted for ethics approval [1] 259886 0
22/10/2010
Approval date [1] 259886 0
Ethics approval number [1] 259886 0

Summary
Brief summary
Remote ischaemic preconditioning is a technique that has been shown to reduce damage to the heart muscle while undergoing coronary artery bypass graft surgery. This study is designed to determine what dose of remote ischaemic preconditioning is best.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31782 0
Address 31782 0
Country 31782 0
Phone 31782 0
Fax 31782 0
Email 31782 0
Contact person for public queries
Name 15029 0
Paul Young
Address 15029 0
c/o ICU
Wellington Hospital
Private Bag 7902
Wellington South
Country 15029 0
New Zealand
Phone 15029 0
+64274552269
Fax 15029 0
Email 15029 0
[email protected]
Contact person for scientific queries
Name 5957 0
Paul Young
Address 5957 0
c/o ICU
Wellington Hospital
Private Bag 7902
Wellington South
Country 5957 0
New Zealand
Phone 5957 0
+64274552269
Fax 5957 0
Email 5957 0
[email protected]

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

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

Documents added automatically
No additional documents have been identified.