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Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery — KIDPROAM  

Acute Kidney Injury Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01245595
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase N/A
Start date November 2010
Completion date May 2014
View Details
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