Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery (KIDPROAM)
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
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Volunteers
Inclusion criteria
- Less than 18 years old, undergoing cardiac surgery with bypass
- neonates must be at least 36 weeks gestational age
Exclusion criteria
- History of arrythmia or seizure, on extracorporeal membrane oxygenation (ECMO) support, already taking aminophylline/theophylline, liver failure, sepsis, on renal replacement therapy
Trial design
Primary purpose
Allocation
Interventional model
Masking
144 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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