Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery (KID PRO AM)

This study is currently recruiting participants.
Verified December 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
David Axelrod, Stanford University
ClinicalTrials.gov Identifier:
NCT01245595
First received: November 19, 2010
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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 Intervention
Acute Kidney Injury
Drug: Aminophylline
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Acute Kidney Injury measured by pRIFLE (pediatric "Risk, Injury, Failure, Loss, End Stage" criteria [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    pRIFLE is a measure of acute kidney injury.


Estimated Enrollment: 160
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo
Normal Saline Placebo
Drug: Placebo
Normal Saline

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.

  Eligibility

Ages Eligible for Study:   36 Weeks to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Less than 18 years old, undergoing cardiac surgery with bypass

Exclusion Criteria:

  • History of arrythmia or seizure, on ECMO, already taking aminophylline/theophylline, liver failure, sepsis, on renal replacement therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245595

Contacts
Contact: David M Axelrod, MD 4153780794 daxelrod@stanford.edu

Locations
United States, California
Lucile Packard Childrens' Hospital Recruiting
Palo Alto, California, United States, 94304
Contact: David M Axelrod, MD       daxelrod@stanford.edu   
Sub-Investigator: David M Axelrod, MD         
Principal Investigator: Stephen J Roth, MD, MPH         
Sponsors and Collaborators
Stanford University
  More Information

No publications provided

Responsible Party: David Axelrod, MD, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01245595     History of Changes
Other Study ID Numbers: 18977
Study First Received: November 19, 2010
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Acute Kidney Injury
Cardiopulmonary bypass

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

ClinicalTrials.gov processed this record on April 15, 2014