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Acetaminophen for Oxidative Stress After Cardiopulmonary Bypass

NCT01228305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-21

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease
  • Cardiopulmonary Bypass

Interventions

OTHER

Acetaminophen

Acetaminophen will be given at a standard dose of 15 mg/kg IV every 6 hours for children \>=2 years of age, 12.5mg/kg IV every 6 hours for children 29 days to \<2 years of age, and 7.5mg/kg IV every 6 hours for neonates up to 28 days old for a total of 4 doses, starting shortly after intubation in the OR and before the start of CPB.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Scott A Simpson, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-01-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01228305 on ClinicalTrials.gov