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Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00848250
First Posted: February 20, 2009
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gregory Fleming, Vanderbilt University Medical Center
  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: None (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 Gregory Fleming, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • (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 ]

Secondary Outcome Measures:
  • 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


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

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Gregory Fleming, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00848250     History of Changes
Other Study ID Numbers: 071078
First Submitted: February 5, 2009
First Posted: February 20, 2009
Results First Submitted: May 1, 2017
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017
Last Verified: June 2017

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

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