Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Hospital
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:Any - 18
Updated:5/5/2014
Start Date:November 2010
End Date:November 2014
Contact:David M Axelrod, MD
Email:daxelrod@stanford.edu
Phone:4153780794

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized Placebo Controlled Trial of Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery With Cardiopulmonary Bypass

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.

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.

Inclusion Criteria:

- Less than 18 years old, undergoing cardiac surgery with bypass

Exclusion Criteria:

- History of arrythmia or seizure, on ECMO, already taking aminophylline/theophylline,
liver failure, sepsis, on renal replacement therapy
We found this trial at
1
site
Lucile Packard Children's Hospital
Palo Alto, California 94304
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from
Palo Alto, CA
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