Overview

Acetaminophen for Oxidative Stress After Cardiopulmonary Bypass

Status:
Unknown status

Trial end date:
0000-00-00

Target enrollment:
30

Participant gender:
Both

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 cardiac surgery.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Vanderbilt University

Treatments:

Acetaminophen

Last Updated:

2012-04-11

Criteria

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:

1. Patients scheduled for single ventricle palliation will be excluded, in an effort to
standardize the time of repair, time on CPB, and surgical procedure.

2. Patients with severe neurological abnormalities at baseline.

3. 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.

4. Non-English speaking patients, or parent/legal guardians.

5. Patients less than 3 kg, to limit risk of excessive blood loss from lab draws.

6. Previous adverse reaction to acetaminophen

7. History of acute or chronic kidney disease

8. History of chronic liver disease

9. Emergency surgery