Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-05-31

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.

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aminophylline

Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours

Group Type ACTIVE_COMPARATOR

Aminophylline

Intervention Type DRUG

5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours

Placebo

Normal Saline Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal Saline

Interventions

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Aminophylline

5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours

Intervention Type DRUG

Placebo

Normal Saline

Intervention Type DRUG

Other Intervention Names

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treatment

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No