Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Drug: Aminophylline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aminophylline<br>Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours | Drug: Aminophylline<br>* 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours<br>* Other names: treatment;|
| Placebo Comparator: Placebo<br>Normal Saline Placebo | Drug: Placebo<br>* Normal Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria | Acute Kidney Injury measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine criteria; KDIGO Stage is a measure of acute kidney injury. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Kidney Injury (AKI), Cardiopulmonary bypass (CPB)