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.

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.

Congenital Heart Disease

Ischemia-reperfusion Injury

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.

Remote ischemic pre-conditioning stimulus.

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.

Sham Ischemic Pre-conditioning

Stollery Children's Hospital

Pediatric Remote Ischemic Pre-conditioning Prior to Complex Cardiac Surgery

This is a pilot study looking at feasibility to conduct a larger randomized controlled study on pediatric remote ischemic pre-conditioning at our center.

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.

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.

Number of days the patient remains on mechanical ventilation after the surgical repair.

Proportion of patients who dies within 30 days of their surgical repair

Number of days the patient remains in the pediatric intensive care unit after the surgical repair

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.

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.

Gonzalo Garcia Guerra

Clinical Assistant Professor

University of Alberta

Women and Children's Health Research Institute, Canada

Drug treatment:
ephedrine sulfate 25-mg with caffeine 200-mg per capsule to be given three times per day 4 hours apart for 6 months after gastric bypass surgery. Weight loss rate, resting energy expenditure, fat free mass will be measured during the treatment.

one placebo capsule will be taken three times per day 4 hours apart, identical to the instructions for the active drug for approximately 6 months following gastric bypass surgery. Weight loss rate, resting energy expenditure and fat free mass will be measured during the treatment.

Morbid Obesity

Ephedrine sulfate 25-mg with caffeine 200-mg combination capsule to start 5 weeks after gastric bypass surgery at 3 times per day 4 hours apart.

Ephedrine sulfate with caffeine

sufficient cellulose to fill a placebo capsule identical to the active drug to be taken 3 times per day 4 hours apart for 6 months after gastric bypass surgery

cellulose

Oregon Weight Loss Surgery, LLC

Oregon Weight Loss Surgery

Treatment of Low Metabolic Rate Following Bariatric Surgery

Treatment of Low Metabolic Rate and Low Weight Loss Rate Following Bariatric Surgery

By indirect calorimetry resting energy expenditure will be calculated from vO2 and vCO2 ratios using the Harris-Benedict Equations

Body Impedance Analysis will be measured at each office visit before and after beginning treatment using a Quantum III BIA from RJL Systems (Michigan)

Body Mass Index will be calculated from weight and height obtained at each office visit.

Arterial blood pressure will be obtain in both arms times two at each office visit.

Heart rate will be determined at two time points in each arm at each office visit.

aminophylline/insult

Pediatric Remote Ischemic Pre-conditioning Prior to Complex Cardiac Surgery

Treatment of Low Metabolic Rate Following Bariatric Surgery

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