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

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ClinicalTrials.gov Identifier: NCT01245595
Recruitment Status : Completed
First Posted : November 22, 2010
Results First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
David Axelrod, 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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: Aminophylline Drug: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Placebo Controlled Trial of Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery With Cardiopulmonary Bypass
Study Start Date : November 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Aminophylline
Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
Drug: Aminophylline
5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
Other Name: treatment
Placebo Comparator: Placebo
Normal Saline Placebo
Drug: Placebo
Normal Saline



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245595


Locations
United States, California
Lucile Packard Childrens' Hospital
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: david m axelrod, md Stanford University

Responsible Party: David Axelrod, MD, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01245595     History of Changes
Other Study ID Numbers: 18977
First Posted: November 22, 2010    Key Record Dates
Results First Posted: June 8, 2015
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by David Axelrod, Stanford University:
Acute Kidney Injury (AKI)
Cardiopulmonary bypass (CPB)

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Aminophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Protective Agents