Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury (AKI) Cardiopulmonary bypass (CPB)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 144
Healthy volunteers: no

Brief summary:
Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass (the "heart-lung machine"). Approximately 35 to 50% of these children will have "acute kidney injury," or damage to the kidneys, after the procedure. We currently have few medications to prevent this kidney injury. The hypothesis of this study is that giving aminophylline after heart surgery can decrease the acute kidney injury.

Detailed description:
Patients are randomized to receive aminophylline or placebo for 72 hours, in a blinded fashion. Serum theophylline levels monitor for safety of aminophylline dose. Goal theophylline levels is 5-7 mcg/ml. Laboratory results will be faxed directly to the pharmacy who will adjust subsequent aminophylline dosing to maintain appropriate theophylline levels. Urine output and serum creatinine levels will be monitored to assess acute kidney injury. Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) levels will also be monitored.

Arms:
arm 1: Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours arm 2: Normal Saline Placebo

Interventions: intervention 1: Aminophylline intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours intervention 2: Normal Saline

Protocol document: