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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
Sponsor:
Information provided by (Responsible Party):
Gregory Fleming, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE February 5, 2009
First Posted Date  ICMJE February 20, 2009
Results First Submitted Date  ICMJE May 1, 2017
Results First Posted Date  ICMJE July 26, 2017
Last Update Posted Date July 26, 2017
Study Start Date  ICMJE September 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
  • (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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
Biomarkers on Ace I versus not on Ace I (Plasminogen Activator Inhibitor -1) [ Time Frame: Day 1 (Postoperative day 8:00AM) ]
Change History Complete list of historical versions of study NCT00848250 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
Official Title  ICMJE Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congenital Heart Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2010)
21
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2009)
50
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00848250
Other Study ID Numbers  ICMJE 071078
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gregory Fleming, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Vanderbilt University Medical Center
Verification Date June 2017

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