Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery
KIDPROAM
A Randomized Placebo Controlled Trial of Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery With Cardiopulmonary Bypass
1 other identifier
interventional
144
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 19, 2010
CompletedFirst Posted
Study publicly available on registry
November 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
June 8, 2015
CompletedJune 8, 2015
June 1, 2015
3.5 years
November 19, 2010
March 31, 2015
June 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria
Acute Kidney Injury measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine criteria; KDIGO Stage is a measure of acute kidney injury.
5 days
Study Arms (2)
Aminophylline
ACTIVE COMPARATORPatients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
Placebo
PLACEBO COMPARATORNormal Saline Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Less than 18 years old, undergoing cardiac surgery with bypass
- neonates must be at least 36 weeks gestational age
You may not qualify if:
- History of arrythmia or seizure, on extracorporeal membrane oxygenation (ECMO) support, already taking aminophylline/theophylline, liver failure, sepsis, on renal replacement therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lucile Packard Childrens' Hospital
Palo Alto, California, 94304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David M. Axelrod
- Organization
- Stanford University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
david m axelrod, md
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Clinical Assistant Professor
Study Record Dates
First Submitted
November 19, 2010
First Posted
November 22, 2010
Study Start
November 1, 2010
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 8, 2015
Results First Posted
June 8, 2015
Record last verified: 2015-06