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Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00848250
First received: February 5, 2009
Last updated: March 30, 2017
Last verified: March 2017
  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: No masking
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 Medical Center:

Primary Outcome Measures:
  • Biomarkers on Ace I versus not on Ace I (Plasminogen Activator Inhibitor -1) [ Time Frame: Day 1 (Postoperative day 8:00AM) ]

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) ]

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
Experimental: 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
Experimental: 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 group will stop their ACE inhibitors 48 hours before surgery

  Eligibility

Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Medical Center
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

Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00848250     History of Changes
Other Study ID Numbers: 071078
Study First Received: February 5, 2009
Last Updated: March 30, 2017

Keywords provided by Vanderbilt University Medical Center:
Cardiopulmonary Bypass
ACE inhibitor
Pediatrics

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

ClinicalTrials.gov processed this record on April 28, 2017