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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00848250 |
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 disease.
Condition | Intervention |
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Congenital Heart Disease |
Drug: Angiotensin Converting Enzyme Inhibitor Other: No ACE inhibitor |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects |
Estimated Enrollment: | 50 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ACE inhibitor: No Intervention
Patients already on an ACE inhibitor will continue it until the day of surgery
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Drug: Angiotensin Converting Enzyme Inhibitor
Patients randomized to this group will continue their current dose of ACE inhibitors until surgery
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No ACE inhibitor
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
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Other: No ACE inhibitor
Patients randomized to this arm will discontinue their ACE inhibitor at least 48 hours prior to surgery
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Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gregory A Fleming, MD | 615-322-7447 | gregory.fleming@vanderbilt.edu |
United States, Tennessee | |
Monroe Carell Jr. Children's Hospital at Vanderbilt | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Fleming gregory.fleming@vanderbilt.edu | |
Principal Investigator: Gregory A Fleming, MD |
Principal Investigator: | Gregory A Fleming, MD | Vanderbilt University Medical Center, Division of Pediatric Cardiology |
Study Director: | Mias Pretorius, MBChB, MSCI | Vanderbilt University Medical Center, Department of Anesthesiology |
Responsible Party: | Vanderbilt University Medical Center, Division of Pediatric Cardiology ( Gregory Fleming, MD/ Principle Investigator ) |
Study ID Numbers: | 071078 |
Study First Received: | February 5, 2009 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00848250 History of Changes |
Health Authority: | United States: Institutional Review Board |
Cardiopulmonary Bypass ACE inhibitor Pediatrics |
Heart Diseases Cardiovascular Abnormalities Angiotensin-Converting Enzyme Inhibitors |
Congenital Abnormalities Heart Defects, Congenital Protease Inhibitors |
Heart Diseases Molecular Mechanisms of Pharmacological Action Cardiovascular Abnormalities Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors |
Cardiovascular Diseases Congenital Abnormalities Heart Defects, Congenital Pharmacologic Actions Protease Inhibitors |