Status:
COMPLETED
Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery
Lead Sponsor:
Stanford University
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
1-18 years
Phase:
NA
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 ...
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/...
Eligibility Criteria
Inclusion
- Less than 18 years old, undergoing cardiac surgery with bypass
- neonates must be at least 36 weeks gestational age
Exclusion
- History of arrythmia or seizure, on extracorporeal membrane oxygenation (ECMO) support, already taking aminophylline/theophylline, liver failure, sepsis, on renal replacement therapy
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01245595
Start Date
November 1 2010
End Date
May 1 2014
Last Update
June 8 2015
Active Locations (1)
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1
Lucile Packard Childrens' Hospital
Palo Alto, California, United States, 94304