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Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

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ClinicalTrials.gov Identifier: NCT00848250
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Information provided by (Responsible Party):

February 5, 2009
February 20, 2009
May 1, 2017
July 26, 2017
July 26, 2017
September 2008
July 2010   (Final data collection date for primary outcome measure)
  • (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 ]
  • t-PA (Tissue-type Plasminogen Activator) Antigen [ Time Frame: Baseline (prior to surgery) to postoperative day 1 ]
Biomarkers on Ace I versus not on Ace I (Plasminogen Activator Inhibitor -1) [ Time Frame: Day 1 (Postoperative day 8:00AM) ]
Complete list of historical versions of study NCT00848250 on ClinicalTrials.gov Archive Site
  • IL-6 (Interleukin-6) [ Time Frame: Baseline (pre-surgery) to postoperative day 1 ]
  • IL-8 (Interleukin-8) [ Time Frame: Baseline (pre-surgery) to postoperative day 1 ]
  • (MAP) Mean Arterial Blood Pressure [ Time Frame: Baseline (prior to surgery) to postoperative day 1 ]
  • Postoperative Bleeding [ Time Frame: 24 hours ]
    Chest tube output at 4 and 24 hours after completion of surgery
  • Postoperative Renal Function [ Time Frame: Baseline (prior to surgery) to postoperative day 1 ]
    Acute kidney injury occurring
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) ]
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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.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 group will stop their ACE inhibitors 48 hours before surgery
  • Experimental: ACE inhibitor
    Patients already on an ACE inhibitor will continue it until the day of surgery
    Intervention: Drug: Angiotensin Converting Enzyme Inhibitor
  • Experimental: 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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.
Sexes Eligible for Study: All
up to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
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Gregory Fleming, Vanderbilt University Medical Center
Vanderbilt University Medical Center
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 Medical Center
June 2017

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