Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848250
• Other study ID #: 071078
• Status: Completed
• Phase: N/A
• First received: February 5, 2009
• Last updated: March 30, 2017
• Start date: September 2008
• Est. completion date: July 2010

Study information

• Verified date: March 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Drug:
• Angiotensin Converting Enzyme Inhibitor
Patients randomized to this group will continue their current dose of ACE inhibitors until surgery

Other:
• No ACE Inhibitor
Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery

Locations

Country	Name	City	State
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers on Ace I versus not on Ace I (Plasminogen Activator Inhibitor -1)		Day 1 (Postoperative day 8:00AM)
Secondary	Comparisons on Ace-I versus not on Ace-I (cytokine profile, bradykinin, bradykinin by-products, troponin, postoperative bleeding, postoperative renal function, arterial blood pressure)		Baseline (Before going on cardiopulmonary bypass (CPB), 30 minutes (on CPB), Admission to ICU following surgery, postoperative day 1 (at 8:00AM)