Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

Completed · Not applicable

Conditions studied: Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT00848250

Run by

Vanderbilt University Medical Center

People needed

21

Starts

2008-09-01

Expected to finish

2010-07-01

Last updated by the study team

2017-07-26

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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