Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00848250
First received: February 5, 2009
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Congenital Heart Disease
Drug: Angiotensin Converting Enzyme Inhibitor
Other: No ACE inhibitor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Biomarkers on Ace I versus not on Ace I (Plasminogen Activator Inhibitor -1) [ Time Frame: Day 1 (Postoperative day 8:00AM) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparisons on Ace-I versus not on Ace-I (cytokine profile, bradykinin, bradykinin by-products, troponin, postoperative bleeding, postoperative renal function, arterial blood pressure) [ Time Frame: Baseline (Before going on cardiopulmonary bypass (CPB), 30 minutes (on CPB), Admission to ICU following surgery, postoperative day 1 (at 8:00AM) ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: September 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: ACE inhibitor
Patients already on an ACE inhibitor will continue it until the day of surgery
Drug: Angiotensin Converting Enzyme Inhibitor
Patients randomized to this group will continue their current dose of ACE inhibitors until surgery
No ACE inhibitor
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
Other: No ACE inhibitor
Patients randomized to this arm will discontinue their ACE inhibitor at least 48 hours prior to surgery

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00848250

Locations
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Gregory A Fleming, MD Vanderbilt University Medical Center, Division of Pediatric Cardiology
Study Director: Mias Pretorius, MBChB, MSCI Vanderbilt University Medical Center, Department of Anesthesiology
  More Information

No publications provided

Responsible Party: Gregory Fleming, MD/ Principle Investigator, Vanderbilt University Medical Center, Division of Pediatric Cardiology
ClinicalTrials.gov Identifier: NCT00848250     History of Changes
Other Study ID Numbers: 071078
Study First Received: February 5, 2009
Last Updated: October 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Cardiopulmonary Bypass
ACE inhibitor
Pediatrics

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014