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Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

NCT00848250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-07-26

Study results available
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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.

Conditions

  • Congenital Heart Disease

Interventions

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

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Gregory A Fleming, MD · Vanderbilt University Medical Center, Division of Pediatric Cardiology

  • Mias Pretorius, MBChB, MSCI · Vanderbilt University Medical Center, Department of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00848250 on ClinicalTrials.gov