Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Drug: Angiotensin Converting Enzyme Inhibitor
* Other: No ACE Inhibitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACE inhibitor<br>Patients already on an ACE inhibitor will continue it until the day of surgery | Drug: Angiotensin Converting Enzyme Inhibitor<br>* Patients randomized to this group will continue their current dose of ACE inhibitors until surgery<br>|
| Experimental: No ACE inhibitor<br>Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery | Other: No ACE Inhibitor<br>* Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (PAI-1) Plasminogen Activator Inhibitor -1 Antigen |  | Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1 | 
| t-PA (Tissue-type Plasminogen Activator) Antigen |  | Baseline (prior to surgery) to postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 (Interleukin-6) |  | Baseline (pre-surgery) to postoperative day 1 | 
| IL-8 (Interleukin-8) |  | Baseline (pre-surgery) to postoperative day 1 | 
| (MAP) Mean Arterial Blood Pressure |  | Baseline (prior to surgery) to postoperative day 1 | 
| Postoperative Bleeding | Chest tube output at 4 and 24 hours after completion of surgery | 24 hours | 
| Postoperative Renal Function | Acute kidney injury occurring | Baseline (prior to surgery) to postoperative day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary Bypass, ACE inhibitor, Pediatrics