Status:
COMPLETED
Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart ...
Eligibility Criteria
Inclusion
- Infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect.
- Patients must be taking an ACE inhibitor prior to their operation
Exclusion
- Patients in which discontinuing ACEIs is deemed unsafe by their primary cardiologist
- Any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study.
- Pregnancy as ruled out by standard of care screening procedures.
- Individuals whose weight is less than 3.5 kg at the time of enrollment.
- Inability to comply with the protocol. ie. Children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00848250
Start Date
September 1 2008
End Date
July 1 2010
Last Update
July 26 2017
Active Locations (1)
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1
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232