Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery (KID PRO AM)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Placebo Controlled Trial of Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery With Cardiopulmonary Bypass|
- Acute Kidney Injury measured by pRIFLE (pediatric "Risk, Injury, Failure, Loss, End Stage" criteria [ Time Frame: 5 days ] [ Designated as safety issue: No ]pRIFLE is a measure of acute kidney injury.
|Study Start Date:||November 2010|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Aminophylline
Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
Placebo Comparator: Placebo
Normal Saline Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245595
|United States, California|
|Lucile Packard Childrens' Hospital|
|Palo Alto, California, United States, 94304|