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Completed

NCT Number: NCT01245595

Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery

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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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Childrens' Hospital

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aminophylline

Drug

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

Other names: treatment

Placebo

Drug

Normal Saline

Primary outcomes

  1. Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: KIDPROAM

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 22, 2010
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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