Pediatric Remote Ischemic Pre-conditioning Prior to Complex Cardiac Surgery

NACompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

March 31, 2017

Study Completion Date

March 31, 2017

Conditions
Congenital Heart DiseaseIschemia-reperfusion Injury
Interventions
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.

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.

Trial Locations (1)

T6G2B3

Stollery Children's Hospital, Edmonton

All Listed Sponsors
collaborator

Women and Children's Health Research Institute, Canada

OTHER

lead

University of Alberta

OTHER

NCT01739088 - Pediatric Remote Ischemic Pre-conditioning Prior to Complex Cardiac Surgery | Biotech Hunter | Biotech Hunter