Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- t-PA (Tissue-type Plasminogen Activator) Antigen
Study Overview
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 disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ACE inhibitor
Patients already on an ACE inhibitor will continue it until the day of surgery
Intervention: Angiotensin Converting Enzyme Inhibitor (Drug)
No ACE inhibitor
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
Intervention: No ACE Inhibitor (Other)
Outcomes
Primary Outcomes
t-PA (Tissue-type Plasminogen Activator) Antigen
Time Frame: Baseline (prior to surgery) to postoperative day 1
(PAI-1) Plasminogen Activator Inhibitor -1 Antigen
Time Frame: Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1
Secondary Outcomes
- IL-6 (Interleukin-6)(Baseline (pre-surgery) to postoperative day 1)
- (MAP) Mean Arterial Blood Pressure(Baseline (prior to surgery) to postoperative day 1)
- Postoperative Bleeding(24 hours)
- Postoperative Renal Function(Baseline (prior to surgery) to postoperative day 1)
- IL-8 (Interleukin-8)(Baseline (pre-surgery) to postoperative day 1)
Investigators
Gregory Fleming
Assistant Professor
Vanderbilt University Medical Center