Clinical Trial: Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Placebo Controlled Trial of Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery With Cardiopulmonary Bypass
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 Summary: 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.
Sponsor: Stanford University
Current Primary Outcome: Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria [ Time Frame: 5 days ]
Original Primary Outcome: Acute Kidney Injury measured by pRIFLE criteria [ Time Frame: 5 days ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Stanford University
Dates:
Date Received: November 19, 2010
Date Started: November 2010
Date Completion:
Last Updated: June 3, 2015
Last Verified: June 2015
