Status:
COMPLETED
Acetaminophen for Oxidative Stress After Cardiopulmonary Bypass
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Congenital Heart Disease
Cardiopulmonary Bypass
Eligibility:
All Genders
1-17 years
Phase:
NA
Brief Summary
The current proposal tests the central hypothesis that acetaminophen will attenuate the oxidative stress response associated with cardiopulmonary bypass (CPB)-induced hemolysis in children undergoing ...
Detailed Description
Infants with complex congenital cardiac defects frequently undergo cardiopulmonary bypass (CBP) during surgical repair of their cardiac lesions (1). CBP exposes infants and children to endothelial dam...
Eligibility Criteria
Inclusion
- Patients will be eligible for enrollment based on the following inclusion criteria:
- 1\) Infants or children (newborn to 17years of age) undergoing cardiopulmonary bypass for biventricular surgical correction of their congenital heart lesions.
- Patients will not be eligible for this study based on the following exclusion criteria:
- Patients scheduled for single ventricle palliation will be excluded, in an effort to standardize the time of repair, time on CPB, and surgical procedure.
- Patients with severe neurological abnormalities at baseline.
- Patients with major non-cardiac congenital malformations, developmental disorders or serious chronic disorders. Benign congenital malformations (such as club foot, ear tags, etc.) will not exclude the subject from the study.
- Non-English speaking patients, or parent/legal guardians.
- Patients less than 3 kg, to limit risk of excessive blood loss from lab draws.
- Previous adverse reaction to acetaminophen
- History of acute or chronic kidney disease
- History of chronic liver disease
- Emergency surgery
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01228305
Start Date
July 1 2011
End Date
March 1 2014
Last Update
April 21 2017
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232