N/A
N=144
Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery
Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT01245595 ↗Enrolled (actual)
144
Serious AEs
2.1%
Results posted
Jun 2015
Primary outcome: Primary: Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria — 43; 36 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aminophylline (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria |
43; 36 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01245595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.