<?xml version="1.0" encoding="UTF-8"?>
<clinical_study rank="136486">
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd
and an XML DTD at:
https://clinicaltrials.gov/ct2/html/images/info/public.dtd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on December 16, 2015</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/show/NCT00848250</url>
</required_header>
<id_info>
<org_study_id>071078</org_study_id>
<nct_id>NCT00848250</nct_id>
</id_info>
<brief_title>Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children</brief_title>
<official_title>Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects</official_title>
<sponsors>
<lead_sponsor>
<agency>Vanderbilt University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Vanderbilt University</source>
<oversight_info>
<authority>United States: Institutional Review Board</authority>
<has_dmc>No</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
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.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>September 2008</start_date>
<completion_date type="Actual">July 2010</completion_date>
<primary_completion_date type="Actual">July 2010</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<study_design>Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment</study_design>
<primary_outcome>
<measure>Biomarkers on Ace I versus not on Ace I (Plasminogen Activator Inhibitor -1)</measure>
<time_frame>Day 1 (Postoperative day 8:00AM)</time_frame>
<safety_issue>No</safety_issue>
</primary_outcome>
<secondary_outcome>
<measure>Comparisons on Ace-I versus not on Ace-I (cytokine profile, bradykinin, bradykinin by-products, troponin, postoperative bleeding, postoperative renal function, arterial blood pressure)</measure>
<time_frame>Baseline (Before going on cardiopulmonary bypass (CPB), 30 minutes (on CPB), Admission to ICU following surgery, postoperative day 1 (at 8:00AM)</time_frame>
<safety_issue>No</safety_issue>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">21</enrollment>
<condition>Congenital Heart Disease</condition>
<arm_group>
<arm_group_label>ACE inhibitor</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Patients already on an ACE inhibitor will continue it until the day of surgery</description>
</arm_group>
<arm_group>
<arm_group_label>No ACE inhibitor</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Angiotensin Converting Enzyme Inhibitor</intervention_name>
<description>Patients randomized to this group will continue their current dose of ACE inhibitors until surgery</description>
<arm_group_label>ACE inhibitor</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>No ACE inhibitor</intervention_name>
<description>Patients randomized to this arm will discontinue their ACE inhibitor at least 48 hours prior to surgery</description>
<arm_group_label>No ACE inhibitor</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
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.
</textblock>
</criteria>
<gender>Both</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>17 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Gregory A Fleming, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Vanderbilt University Medical Center, Division of Pediatric Cardiology</affiliation>
</overall_official>
<overall_official>
<last_name>Mias Pretorius, MBChB, MSCI</last_name>
<role>Study Director</role>
<affiliation>Vanderbilt University Medical Center, Department of Anesthesiology</affiliation>
</overall_official>
<location>
<facility>
<name>Monroe Carell Jr. Children's Hospital at Vanderbilt</name>
<address>
<city>Nashville</city>
<state>Tennessee</state>
<zip>37232</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>October 2010</verification_date>
<lastchanged_date>October 25, 2010</lastchanged_date>
<firstreceived_date>February 5, 2009</firstreceived_date>
<responsible_party>
<name_title>Gregory Fleming, MD/ Principle Investigator</name_title>
<organization>Vanderbilt University Medical Center, Division of Pediatric Cardiology</organization>
</responsible_party>
<keyword>Cardiopulmonary Bypass</keyword>
<keyword>ACE inhibitor</keyword>
<keyword>Pediatrics</keyword>
<is_fda_regulated>No</is_fda_regulated>
<has_expanded_access>No</has_expanded_access>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Heart Defects, Congenital</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Angiotensin-Converting Enzyme Inhibitors</mesh_term>
<mesh_term>Enzyme Inhibitors</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
