Pediatric Remote Ischemic Pre-conditioning Prior to Complex Cardiac Surgery (PREP)
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|ClinicalTrials.gov Identifier: NCT01739088|
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease Ischemia-reperfusion Injury||Other: Remote ischemic pre-conditioning stimulus. Other: Sham Ischemic Pre-conditioning||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pediatric Remote Ischemic Pre-conditioning Prior to Complex Cardiac Surgery|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||March 31, 2017|
|Actual Study Completion Date :||March 31, 2017|
Experimental: Remote ischemic preconditioning stimulus
The remote ischemic pre-conditioning arm of the study is the experimental one. Patients in this arm will receive a remote ischemic pre-conditioning stimulus at 24-48 hours pre-operatively, and again intra-operatively before CPB.
Other: Remote ischemic pre-conditioning stimulus.
Forty eight to 24 hours prior to the surgery, patient assigned to remote ischemic pre-conditioning stimulus (RIPC) will have blood pressure cuffs placed on both lower limbs around the upper thigh, and will then have the cuff inflated around the lower limb to a pressure 10 mmHg above systolic blood pressure for 5 minutes, followed by 5 minutes of cuff deflation. This will be done sequentially on each lower limb for two cycles on each limb. In the operating room, after induction of anesthesia, the exact same procedure will be performed in the RIPC group. For each intervention, the legs will be covered by a drape, so that whether the cuff is being inflated around the leg or underneath the leg is not seen by any member of the health care team.
Sham Comparator: Sham Ischemic Pre-conditioning
In the control (sham-RIPC) group the cuff will be placed just underneath the upper thigh and the cuff will be inflated for 5 minutes, followed by 5 minutes of cuff deflation, done sequentially for two cycles on each side. In the operating room, after induction of anesthesia, the exact same procedure will be performed in the the control group.
Other: Sham Ischemic Pre-conditioning
In the control (sham Ischemic Pre-conditioning) group 48 to 24 hours prior to the surgery a cuff will be placed just underneath the upper thigh and the cuff will be inflated for 5 minutes, followed by 5 minutes of cuff deflation, done sequentially for two cycles on each side.In the operating room, after induction of anesthesia, the exact same procedure will be performed in the RIPC group.
- To demonstrate the feasibility of patient recruitment to a remote ischemic pre-conditioning randomized controlled trial at our center [ Time Frame: One year ]This is a pilot study looking at feasibility to conduct a larger randomized controlled study on pediatric remote ischemic pre-conditioning at our center.
- Troponin I levels [ Time Frame: One year ]We will obtain blood samples for troponin I levels pre-Cardiopulmonary bypass, 3, 6, 12 and 24 hours after the surgery. Troponin I levels, as a marker of myocardial ischemia, have been used in previous adult and pediatric studies on preconditioning.
- Highest inotropic score during the first 24 hours after cardiac surgery [ Time Frame: 24 hours after the surgery ]
Inotrope score is a useful predictor of morbidity and mortality in children who undergo heart surgery.
The inotropic score is calculated as follows: 1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. Inotrope score is a useful predictor of morbidity and mortality in children who undergo heart surgery.
- Mechanical ventilation days [ Time Frame: 30 days ]Number of days the patient remains on mechanical ventilation after the surgical repair.
- Mortality at 30 days [ Time Frame: 30 days ]Proportion of patients who dies within 30 days of their surgical repair
- Intensive care unit length of stay [ Time Frame: 30 days ]Number of days the patient remains in the pediatric intensive care unit after the surgical repair
- Neurodevelopmental outcome [ Time Frame: 2 years ]The Bayley Scales of Infant and Toddler Development (bayley III) will be used to evaluate the long term outcome of the study subjects. Bayley III is a widely accepted standardized outcome measure used in neonatal follow-up clinics is part of the assessment routinely performed in these patients by the Pediatric Complex Therapies Program.Five certified pediatric psychologist (blinded to treatment allocation) will assess the neurodevelopmental outcomes at the tertiary site of origin.
- Highest arterial lactate level during the first 24 hours after surgical repair for congenital heart disease. [ Time Frame: 24 hours ]Peak lactate levels during the first 24 hours after surgical repair for congenital heart disease it has consistently shown to be associated with neurodevelopmental outcomes in the long term. Arterial blood lactate levels are obtained every 2 hours as a standard of care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739088
|Stollery Children's Hospital|
|Edmonton, Alberta, Canada, T6G2B3|
|Principal Investigator:||Gonzalo Garcia Guerra, MD, MSc||University of Alberta|
|Study Chair:||Ari Joffe, MD||University of Alberta|