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

Additional Aminophylline therapy to hydration (sodium bicarbonate) and N-acetilcysteine

Control group treated with hydration (sodium bicarbonate) and N-acetilcysteine

Acute Kidney Injury

200 mg of aminophylline administrated intravenously as a short infusion, started in emergency department, before primary angioplasty and contrast medium administration
Sodium bicarbonate (154 mEq/L in dextrose and H20) 3mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after procedure
N-acetilcysteine: intravenous bolus of 1200 mg before angioplasty and 1200 mg twice daily for the 48 hours after PCI

Aminophylline

Sodium bicarbonate (154 mEq/L in dextrose and H20) 3mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after procedure
N-acetilcysteine: intravenous bolus of 1200 mg before angioplasty and 1200 mg twice daily for the 48 hours after PCI

Hydration plus N-acetylcisteine

Ospedale Misericordia e Dolce

Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

Effect of Aminophylline on Contrast Induced Acute Kidney Injury in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty

Contrast-Induced Acute Kidney Injury is defined as an increase in serum creatinine of >=25% or 0.5 mg/dL over the baseline value within 3 days after the administration of the contrast medium

Adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration

Mauro Maioli

Medical Doctor

control group: patients receive a preventive hydration with 154mEq/l saline at an ongoing rate of 1ml/kg per hour of at least 12 hours prior and after the procedure.

7h-sodium bicarbonate (according to the regimen used in a recently published study (slightly modified)14): before contrast a bolus of 3ml/kg NaHCO3 166mEq/l for one hour, followed by an infusion of NaHCO3 166mEq/l with a rate of 1ml/kg per hour until 6h after contrast.

short-term sodium bicarbonate: NaHCO3 166mEq/l (3ml/kg; patients with a body weight above 100kg 300ml) as a bolus 20 minutes before contrast; additionally ingestion of Nephrotrans® (500mg NaHCO3/capsule: 1 capsule/10kg) with 1-2 dl of San Pellegrino® non-sparkling mineral water at the start of the infusion. Ingestion of 500ml San Pellegrino® non-sparkling mineral water in the first 6 hours after contrast.

Kidney Failure, Acute

control group: preventive hydration with 154mEq/l saline at 1ml/kg per hour of 12 hours prior and after the procedure.
7h-sodium bicarbonate: before contrast 3ml/kg NaHCO3 166mEq/l for one hour, followed by NaHCO3 166mEq/l (1ml/kg per hour until 6h after contrast).
short-term sodium bicarbonate: NaHCO3 166mEq/l (3ml/kg) as a bolus 20 minutes before contrast; ingestion of Nephrotrans® (500mg NaHCO3/capsule: 1 capsule/10kg) with 1-2 dl non-sparkling mineral water at the start of the infusion. Ingestion of non-sparkling mineral water in the first 6 hours after contrast.

aminophylline/infarction

Pediatric Remote Ischemic Pre-conditioning Prior to Complex Cardiac Surgery

Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION

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