<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01725776</url>
  </required_header>
  <id_info>
    <org_study_id>ICM 06-888</org_study_id>
    <nct_id>NCT01725776</nct_id>
  </id_info>
  <brief_title>Inhaled Milrinone in Cardiac Surgery</brief_title>
  <official_title>Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montreal Heart Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fonds de la Recherche en Santé du Québec</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Justine's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Montreal Heart Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the concentration-effect relationship of inhaled&#xD;
      milrinone after prophylactic administration in cardiac surgical patients with preoperative&#xD;
      pulmonary hypertension undergoing cardiopulmonary bypass.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Milrinone elimination will be verify with blood and urine samples analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2006</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Study the elimination rate of milrinone administered by inhalation</measure>
    <time_frame>up to 24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone</measure>
    <time_frame>15 min after the of study drug administration</time_frame>
    <description>hemodynamic values evaluated will be: central venous pressure, systolic and diastolic pulmonary pressure, wedge, cardiac output, cardiac frequency, systolic and diastolic pressure, SaO2, EtCO2. Patient will also have arterial and venous gaz. Echographic values will be evaluated to see the cardiac fonction: left and right ventricular systolic and diastolic function and valvular function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confirmation of the safety of inhaled milrinone</measure>
    <time_frame>24 hours after cardiac surgery</time_frame>
    <description>Verification of the absence of deleterious effects on cardiac output and systemic arterial pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension</measure>
    <time_frame>15 min after end of milrinone administration</time_frame>
    <description>Efficacy in the treatment of pulmonary hypertension is defined as a reduction of the mean pulmonary pressure of 10-20 %</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>Inhaled milrinone 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inhaled milrinone 5 mg(as for the injectable solution)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Inhaled milrinone 5 mg</intervention_name>
    <description>Inhaled milrinone 5 mg (as for the injectable solution)</description>
    <arm_group_label>Inhaled milrinone 5 mg</arm_group_label>
    <other_name>Primacor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for elective cardiac surgery under CPB&#xD;
&#xD;
          -  High risk patients: NYHA class II-III&#xD;
&#xD;
          -  Preoperative diagnostic of pulmonary hypertension:&#xD;
&#xD;
               -  Systolic pulmonary artery pressure (sPAP) &gt; 35 mm Hg; or&#xD;
&#xD;
               -  Mean pulmonary artery pressure (mPAP) &gt; 25 mm Hg; or&#xD;
&#xD;
               -  mAP/mPAP &lt; 3.0 (after induction of anesthesia).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Open Heart Surgery&#xD;
&#xD;
          -  Contraindication to transesophageal echocardiography (TEE)&#xD;
&#xD;
          -  Hemodynamic instability before surgery&#xD;
&#xD;
          -  Emergency surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrée Denault, MD PhD FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montreal Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montreal Heart Institute</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>June 18, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>November 8, 2012</last_update_submitted>
  <last_update_submitted_qc>November 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montreal Heart Institute</investigator_affiliation>
    <investigator_full_name>Andre Denault</investigator_full_name>
    <investigator_title>MD PhD FRCPC ABIM-CCM</investigator_title>
  </responsible_party>
  <keyword>Pulmonary hypertension</keyword>
  <keyword>Cardiac surgery</keyword>
  <keyword>Cardiopulmonary Bypass (CPB)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Milrinone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01725776
org study id: ICM 06-888
nct id: NCT01725776
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the concentration-effect relationship of inhaled
      milrinone after prophylactic administration in cardiac surgical patients with preoperative
      pulmonary hypertension undergoing cardiopulmonary bypass.
Milrinone elimination will be verify with blood and urine samples analysis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Study the elimination rate of milrinone administered by inhalation
time frame: up to 24 hours
measure: Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone
time frame: 15 min after the of study drug administration
description: hemodynamic values evaluated will be: central venous pressure, systolic and diastolic pulmonary pressure, wedge, cardiac output, cardiac frequency, systolic and diastolic pressure, SaO2, EtCO2. Patient will also have arterial and venous gaz. Echographic values will be evaluated to see the cardiac fonction: left and right ventricular systolic and diastolic function and valvular function.
measure: Confirmation of the safety of inhaled milrinone
time frame: 24 hours after cardiac surgery
description: Verification of the absence of deleterious effects on cardiac output and systemic arterial pressure.
measure: Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension
time frame: 15 min after end of milrinone administration
description: Efficacy in the treatment of pulmonary hypertension is defined as a reduction of the mean pulmonary pressure of 10-20 %
arm group label: Inhaled milrinone 5 mg
arm group type: Experimental
description: Inhaled milrinone 5 mg(as for the injectable solution)
intervention type: Drug
intervention name: Inhaled milrinone 5 mg
description: Inhaled milrinone 5 mg (as for the injectable solution)
arm group label: Inhaled milrinone 5 mg
other name: Primacor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Andrée Denault, MD PhD FRCPC
role: Principal Investigator
affiliation: Montreal Heart Institute
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Montreal Heart Institute
investigator full name: Andre Denault
investigator title: MD PhD FRCPC ABIM-CCM
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Milrinone