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

February 5, 2009
October 25, 2010
September 2008
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00848250 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Congenital Heart Disease
  • 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 arm will discontinue their ACE inhibitor at least 48 hours prior to surgery
  • No Intervention: ACE inhibitor
    Patients already on an ACE inhibitor will continue it until the day of surgery
    Intervention: Drug: Angiotensin Converting Enzyme Inhibitor
  • No ACE inhibitor
    Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
    Intervention: Other: No ACE inhibitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00848250
071078
No
Gregory Fleming, MD/ Principle Investigator, Vanderbilt University Medical Center, Division of Pediatric Cardiology
Vanderbilt University
Not Provided
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
Vanderbilt University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP