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Trial registered on ANZCTR


Registration number
ACTRN12609000965202
Ethics application status
Approved
Date submitted
8/11/2009
Date registered
9/11/2009
Date last updated
13/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Remote Ischaemic Preconditioning in High Risk Adult Cardiac Surgery
Scientific title
A Partially Blinded Randomised Trial in Adults Undergoing High Risk Cardiac Surgery Comparing the Effect of Remote Ischaemic Preconditioning with no Remote Ischaemic Preconditioning on Inotrope Requirements, Renal Failure and Myocardial infarction in the Perioperative Period
Secondary ID [1] 251937 0
Ischaemic Preconditioning
Universal Trial Number (UTN)
U1111-1112-4333
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult cardiac surgery 252137 0
Condition category
Condition code
Cardiovascular 252344 252344 0 0
Coronary heart disease
Surgery 252351 252351 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A blood pressure cuff will be inflated to 200mmHg on an upper limb for five minutes and then deflated for five minutes. This cycle will be repeated three times. The intervention will be performed after induction of anaesthesia prior to onset of cardiopulmonary bypass
Intervention code [1] 241513 0
Treatment: Other
Intervention code [2] 241520 0
Treatment: Surgery
Comparator / control treatment
A blood pressure cuff will be placed on the arm but not inflated. The intervention will be performed after induction of anaesthesia prior to the onset of cardiopulmonary bypass
Control group
Placebo

Outcomes
Primary outcome [1] 253221 0
cumulative total inotrope use after cardiac surgery (total administered dose in mcg/kg will be recorded prospectively on the study datasheet)
Timepoint [1] 253221 0
3,6,12 and 24 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
Primary outcome [2] 253222 0
Post-operative worst level of acute kidney injury based on RIFLE criteria
Timepoint [2] 253222 0
Post-operative period up until hospital discharge
Primary outcome [3] 253223 0
serum troponin
Timepoint [3] 253223 0
6 and 12 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
Secondary outcome [1] 262167 0
Time until ready for extubation
Timepoint [1] 262167 0
post-operatively
Secondary outcome [2] 262168 0
proportion of patients extubated
Timepoint [2] 262168 0
12 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
Secondary outcome [3] 262169 0
Interleukin 6 levels in blood (blood analysis)
Timepoint [3] 262169 0
0, 1, 2, 3, 6, 12 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
Secondary outcome [4] 262170 0
Interleukin 8 levels in blood (blood analysis)
Timepoint [4] 262170 0
0, 1, 2, 3, 6, 12 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
Secondary outcome [5] 262171 0
Interleukin 10 levels in blood (blood analysis)
Timepoint [5] 262171 0
0, 1, 2, 3, 6, 12 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
Secondary outcome [6] 262172 0
tumour necrosis factor (TNF) alpha levels in blood (blood analysis)
Timepoint [6] 262172 0
0, 1, 2, 3, 6, 12 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
Secondary outcome [7] 262173 0
volume of intravenous fluid infused
Timepoint [7] 262173 0
12 hours from the commencement of surgery up to 12 hours following surgery
Secondary outcome [8] 294393 0
Duration of vasopressor support
Timepoint [8] 294393 0
Time until free from intravenous vasoactive support and remains free for remainder of index ICU admission

Eligibility
Key inclusion criteria
Patient undergoing high risk cardiac surgery defined as:
(i) Bentall’s procedure
(ii) Double or triple valve
(iii) mitral valve replacement
(iv) coronary artery bypass graft (CABG) + valve replacement
(v) CABG with ejection fraction<50%
(vi) Any redo operation
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
peripheral vascular disease affecting the upper limbs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking 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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2307 0
New Zealand
State/province [1] 2307 0

Funding & Sponsors
Funding source category [1] 243985 0
Hospital
Name [1] 243985 0
Wellington Hospital
Address [1] 243985 0
Intensive Care Unit
Wellington Hospital
Private Bag 7902
Wellington South 6021
Country [1] 243985 0
New Zealand
Funding source category [2] 243986 0
University
Name [2] 243986 0
Victoria University of Wellington
Address [2] 243986 0
Victoria University of Wellington
PO Box 600
Wellington 6140
Country [2] 243986 0
New Zealand
Primary sponsor type
Individual
Name
Paul Young
Address
Intensive Care Unit
Wellington Hospital
Private Bag 7902
Wellington South 6021
Country
New Zealand
Secondary sponsor category [1] 251338 0
None
Name [1] 251338 0
Address [1] 251338 0
Country [1] 251338 0
Other collaborator category [1] 937 0
Individual
Name [1] 937 0
Dr Shawn Sturland
Address [1] 937 0
Intensive Care Unit
Wellington Hospital
Private Bag 7902
Wellington South 6021
Country [1] 937 0
New Zealand
Other collaborator category [2] 938 0
Individual
Name [2] 938 0
Dr Sandy Garden
Address [2] 938 0
c/o Department of Anaesthesia
Wellington Hospital
Private Bag 7902
Wellington South 6021
Country [2] 938 0
New Zealand
Other collaborator category [3] 939 0
Individual
Name [3] 939 0
Paul Dalley
Address [3] 939 0
c/o Department of Anaesthesia
Wellington Hospital
Private Bag 7902
Wellington South 6021
Country [3] 939 0
New Zealand
Other collaborator category [4] 940 0
Individual
Name [4] 940 0
John Miller
Address [4] 940 0
School of Biological Sciences
Victoria University of Wellington
PO Box 600
Wellington 6140
Country [4] 940 0
New Zealand
Other collaborator category [5] 941 0
Individual
Name [5] 941 0
Anne La Flamme
Address [5] 941 0
School of Biological Sciences
Victoria University of Wellington
PO Box 600
Wellington 6140
Country [5] 941 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244093 0
Central Region Ethics Committee of Health Research Council of New Zealand
Ethics committee address [1] 244093 0
Central Region Ethics Committee of Health Research Council of New Zealand
Ethics committee country [1] 244093 0
New Zealand
Date submitted for ethics approval [1] 244093 0
20/11/2009
Approval date [1] 244093 0
10/02/2010
Ethics approval number [1] 244093 0

Summary
Brief summary
This study will investigate whether ‘remote ischaemic preconditioning’ (RIPC) decreases complications after high risk cardiac surgery. RIPC involves 3 five minute cycles of ischaemia and reperfusion to an arm applied prior to being put on the heart lung machine for heart surgery. The ischaemia involves inflation of a blood pressure cuff to a level that prevents blood flow to the arm beyond it. Reperfusion involves releasing the blood pressure cuff. While on the heart-lung machine, the heart, lungs and abdominal organs receive less blood supply than normal. There is evidence that RIPC prior to going on the heart-lung machine protects the heart from the decreased blood supply during heart surgery. We are performing this trial to test whether RIPC decreases the risk of heart, lung, kidney and bleeding complications after cardiac surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30473 0
Address 30473 0
Country 30473 0
Phone 30473 0
Fax 30473 0
Email 30473 0
Contact person for public queries
Name 13720 0
Paul Young
Address 13720 0
c/o Intensive Care Unit
Wellington Hospital
Private Bag 7902
Wellington South 6021
Country 13720 0
New Zealand
Phone 13720 0
+ 64 4 806 0432
Fax 13720 0
+ 64 4 806 0430
Email 13720 0
paul.young@ccdhb.org.nz
Contact person for scientific queries
Name 4648 0
Paul Young
Address 4648 0
c/o Intensive Care Unit
Wellington Hospital
Private Bag 7902
Wellington South 6021
Country 4648 0
New Zealand
Phone 4648 0
+ 64 4 806 0432
Fax 4648 0
+ 64 4 806 0430
Email 4648 0
paul.young@cchdb.org.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary