Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Aminophylline; Drug: Placebo

• Registration Number: NCT01245595
• Lead Sponsor: Stanford University

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 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

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2015-03-31
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-03
• Last Update Submitted: 2015-06-03
• Results First Posted: 2015-06-08
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aminophylline	Aminophylline	Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
Placebo	Placebo	Normal Saline Placebo

Primary Outcome Measures

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

Trial Locations

Locations (1)

Lucile Packard Childrens' Hospital; 🇺🇸 Palo Alto, California, United States