At a glance
ClinicalIndex Comparison RecordN/ACompleted· 144 enrolled
Drug / intervention
Aminophylline +1 moredrug
Likely dose
Aminophylline 5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Placebo Controlled Trial of Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery With Cardiopulmonary Bypass
In Brief
A clinical study evaluating Aminophylline and Placebo for Acute Kidney Injury. Completed, enrolled 144 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Kidney Injury
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedNov 2010
Primary CompletionMay 2014
TodayJul 2026
First PostedNov 22, 2010
Enrollment StartNov 1, 2010
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 15.6 years ago
Interventions
Aminophyllinedrug
5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
Placebodrug
Normal Saline