Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2008-03-31
2012-12-31
Brief Summary
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Detailed Description
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In humans, it has been have shown that RIPC downregulates genes responsible for pro-inflammatory pathways concerned with TNFα-signaling, apoptosis and exocytosis in circulating leukocytes, reduces ischemia-induced endothelial dysfunction, and decreases markers of myocardial and lung injury in a pilot study of children undergoing open heart surgery. However, the latter study was not powered to demonstrate differences in anatomic and age-related subgroups, or clinically relevant 'hard' end-points such as ventilation time, intensive care, and length of hospital stay.
Thus, we are now proposing a large-scale clinical study examining genetic predictors of clinically relevant postoperative outcomes, and how they are modified by remote preconditioning.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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1
Remote ischemic preconditioning (RIPC)
The RIPC stimulus will be delivered in the OR prep room after the induction of anesthesia (while the anesthesiologist and staff are inserting vascular cannulae and preparing the patient for surgery). Whenever possible, the left lower limb will be selected for delivery of the stimulus. An appropriate sized cuff will be selected and connected to a hand aneroid sphygmomanometer. A second cuff and hand aneroid sphygmomanometer will be placed beside the one connected to the study subject. The cuff on the limb will be inflated and deflated to provide a total of four cycles of limb ischemia and reperfusion.
2
SHAM
For this group, the procedure will be identical for that described for the RIPC stimulus, with the exception that the blood pressure cuff placed on the subject will not be inflated, but the second cuff, that has been placed beside, will be inflated.
Interventions
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Remote ischemic preconditioning (RIPC)
The RIPC stimulus will be delivered in the OR prep room after the induction of anesthesia (while the anesthesiologist and staff are inserting vascular cannulae and preparing the patient for surgery). Whenever possible, the left lower limb will be selected for delivery of the stimulus. An appropriate sized cuff will be selected and connected to a hand aneroid sphygmomanometer. A second cuff and hand aneroid sphygmomanometer will be placed beside the one connected to the study subject. The cuff on the limb will be inflated and deflated to provide a total of four cycles of limb ischemia and reperfusion.
SHAM
For this group, the procedure will be identical for that described for the RIPC stimulus, with the exception that the blood pressure cuff placed on the subject will not be inflated, but the second cuff, that has been placed beside, will be inflated.
Eligibility Criteria
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Inclusion Criteria
* Underlying cardiac anatomy and planned primary repair with no anticipated residual shunting. Repair must necessitate use of cardiopulmonary bypass.
* Informed consent/assent of subject, parent(s) or legal guardian as appropriate.
Exclusion Criteria
* Evidence in any system for organ dysfunction that requires medical intervention.
* Current treatment with systemic anticoagulation therapy or the presence of a bleeding diathesis.
* Presence of important pulmonary or airway disease requiring medical intervention.
* Current or previous (within 10 days of screening) use of systemic corticosteroids.
* Recent (within 7 days of screening) or current documented systemic infection or sepsis.
* Anticipated unavailability of an uninstrumented limb with no anatomic or physiologic abnormality precluding administration of RIPC stimulus using a standard blood pressure cuff.
1 Day
17 Years
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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Brian McCrindle
Staff Cardiologist
Principal Investigators
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Brian W. McCrindle, MD MPH
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Andrew N. Redington, MB
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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Brian W. McCrindle
Toronto, Ontario, Canada
Countries
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References
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McCrindle BW, Clarizia NA, Khaikin S, Holtby HM, Manlhiot C, Schwartz SM, Caldarone CA, Coles JG, Van Arsdell GS, Scherer SW, Redington AN. Remote ischemic preconditioning in children undergoing cardiac surgery with cardiopulmonary bypass: a single-center double-blinded randomized trial. J Am Heart Assoc. 2014 Jul 28;3(4):e000964. doi: 10.1161/JAHA.114.000964.
Other Identifiers
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1000011898
Identifier Type: -
Identifier Source: org_study_id