Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

Vanderbilt University Medical Center

Status

Completed

Conditions

Congenital Heart Disease

Treatments

Drug: Angiotensin Converting Enzyme Inhibitor

Other: No ACE Inhibitor

Study type

Interventional

Funder types

Other

Identifiers

NCT00848250

071078

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.