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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
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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
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Secondary ID [1]
251937
0
Ischaemic Preconditioning
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Universal Trial Number (UTN)
U1111-1112-4333
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Adult cardiac surgery
252137
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Condition category
Condition code
Cardiovascular
252344
252344
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0
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Coronary heart disease
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Surgery
252351
252351
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
241513
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Treatment: Other
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Intervention code [2]
241520
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Treatment: Surgery
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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
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Control group
Placebo
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Outcomes
Primary outcome [1]
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cumulative total inotrope use after cardiac surgery (total administered dose in mcg/kg will be recorded prospectively on the study datasheet)
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Assessment method [1]
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Timepoint [1]
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3,6,12 and 24 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
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Primary outcome [2]
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Post-operative worst level of acute kidney injury based on RIFLE criteria
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Assessment method [2]
253222
0
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Timepoint [2]
253222
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Post-operative period up until hospital discharge
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Primary outcome [3]
253223
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serum troponin
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Assessment method [3]
253223
0
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Timepoint [3]
253223
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6 and 12 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
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Secondary outcome [1]
262167
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Time until ready for extubation
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Assessment method [1]
262167
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Timepoint [1]
262167
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post-operatively
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Secondary outcome [2]
262168
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proportion of patients extubated
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Assessment method [2]
262168
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Timepoint [2]
262168
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12 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
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Secondary outcome [3]
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Interleukin 6 levels in blood (blood analysis)
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Assessment method [3]
262169
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Timepoint [3]
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0, 1, 2, 3, 6, 12 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
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Secondary outcome [4]
262170
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Interleukin 8 levels in blood (blood analysis)
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Assessment method [4]
262170
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Timepoint [4]
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0, 1, 2, 3, 6, 12 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
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Secondary outcome [5]
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Interleukin 10 levels in blood (blood analysis)
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Assessment method [5]
262171
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Timepoint [5]
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0, 1, 2, 3, 6, 12 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
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Secondary outcome [6]
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tumour necrosis factor (TNF) alpha levels in blood (blood analysis)
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Assessment method [6]
262172
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Timepoint [6]
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0, 1, 2, 3, 6, 12 hours following removal of aortic cross clamp during weaning from cardiopulmonary bypass
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Secondary outcome [7]
262173
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volume of intravenous fluid infused
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Assessment method [7]
262173
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Timepoint [7]
262173
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12 hours from the commencement of surgery up to 12 hours following surgery
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Secondary outcome [8]
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Duration of vasopressor support
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Assessment method [8]
294393
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Timepoint [8]
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Time until free from intravenous vasoactive support and remains free for remainder of index ICU admission
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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
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Minimum age
18
Years
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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
peripheral vascular disease affecting the upper limbs
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Study design
Purpose of the study
Treatment
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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?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/02/2010
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Actual
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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
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
2307
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New Zealand
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State/province [1]
2307
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Funding & Sponsors
Funding source category [1]
243985
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Hospital
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Name [1]
243985
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Wellington Hospital
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Address [1]
243985
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Intensive Care Unit
Wellington Hospital
Private Bag 7902
Wellington South 6021
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Country [1]
243985
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New Zealand
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Funding source category [2]
243986
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University
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Name [2]
243986
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Victoria University of Wellington
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Address [2]
243986
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Victoria University of Wellington
PO Box 600
Wellington 6140
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Country [2]
243986
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New Zealand
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Primary sponsor type
Individual
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Name
Paul Young
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Address
Intensive Care Unit
Wellington Hospital
Private Bag 7902
Wellington South 6021
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Country
New Zealand
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Secondary sponsor category [1]
251338
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None
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Name [1]
251338
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Address [1]
251338
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Country [1]
251338
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Other collaborator category [1]
937
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Individual
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Name [1]
937
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Dr Shawn Sturland
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Address [1]
937
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Intensive Care Unit
Wellington Hospital
Private Bag 7902
Wellington South 6021
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Country [1]
937
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New Zealand
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Other collaborator category [2]
938
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Individual
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Name [2]
938
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Dr Sandy Garden
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Address [2]
938
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c/o Department of Anaesthesia
Wellington Hospital
Private Bag 7902
Wellington South 6021
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Country [2]
938
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New Zealand
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Other collaborator category [3]
939
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Individual
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Name [3]
939
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Paul Dalley
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Address [3]
939
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c/o Department of Anaesthesia
Wellington Hospital
Private Bag 7902
Wellington South 6021
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Country [3]
939
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New Zealand
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Other collaborator category [4]
940
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Individual
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Name [4]
940
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John Miller
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Address [4]
940
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School of Biological Sciences
Victoria University of Wellington
PO Box 600
Wellington 6140
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Country [4]
940
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New Zealand
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Other collaborator category [5]
941
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Individual
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Name [5]
941
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Anne La Flamme
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Address [5]
941
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School of Biological Sciences
Victoria University of Wellington
PO Box 600
Wellington 6140
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Country [5]
941
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
244093
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Central Region Ethics Committee of Health Research Council of New Zealand
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Ethics committee address [1]
244093
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Central Region Ethics Committee of Health Research Council of New Zealand
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Ethics committee country [1]
244093
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New Zealand
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Date submitted for ethics approval [1]
244093
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20/11/2009
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Approval date [1]
244093
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10/02/2010
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Ethics approval number [1]
244093
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
30473
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Address
30473
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Country
30473
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Phone
30473
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Fax
30473
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Email
30473
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Contact person for public queries
Name
13720
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Paul Young
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Address
13720
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c/o Intensive Care Unit
Wellington Hospital
Private Bag 7902
Wellington South 6021
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Country
13720
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New Zealand
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Phone
13720
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+ 64 4 806 0432
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Fax
13720
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+ 64 4 806 0430
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Email
13720
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[email protected]
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Contact person for scientific queries
Name
4648
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Paul Young
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Address
4648
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c/o Intensive Care Unit
Wellington Hospital
Private Bag 7902
Wellington South 6021
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Country
4648
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New Zealand
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Phone
4648
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+ 64 4 806 0432
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Fax
4648
0
+ 64 4 806 0430
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Email
4648
0
[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Remote ischaemic preconditioning does not alter perioperative cytokine production in high-risk cardiac surgery.
2014
https://dx.doi.org/10.1136/heartasia-2012-010122
N.B. These documents automatically identified may not have been verified by the study sponsor.
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