<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/NCT04484675</url>
  </required_header>
  <id_info>
    <org_study_id>milrinone in cardiadc surgery</org_study_id>
    <nct_id>NCT04484675</nct_id>
  </id_info>
  <brief_title>Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension</brief_title>
  <official_title>Comparative Study Between Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension Undergoing Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator compared difference between inhaled and intravenous milirinone in patiens&#xD;
      with severe pulmonary hypertension undergoing cardiac surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Milrinone is widely used in cardiac surgery as an inotrope and pulmonary vasodilator agent&#xD;
      But , intravenous milrinone has been associated with systemic hypotension and increased&#xD;
      requirement for vasoactive drugs&#xD;
&#xD;
      The investigator compared difference between inhaled and intravenous milirinone in patiens&#xD;
      with severe pulmonary hypertension undergoing cardiac surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 20, 2022</start_date>
  <completion_date type="Anticipated">February 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>mean arterial pressure</measure>
    <time_frame>change in mean arterial pressure is recorded 10 minutes after milrinone administration after induction (T1), at the end of nebulization (T2), before cardiopulmonary bypass (T3) and after cardiopulmonary bypass(T4)</time_frame>
    <description>The effect of inhaled milrinone on mean arterial pressure is compared with the effect of intravenous milrinone</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mean pulmonary arterial pressure</measure>
    <time_frame>change in mean pulmonary arterial pressure 10 minutes after milrinone administration</time_frame>
    <description>The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>systemic vascular resistance</measure>
    <time_frame>change in systemic vascular resistance 10 minutes after milrinone administration</time_frame>
    <description>The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulmonary vascular resistance</measure>
    <time_frame>change in pulmonary vascular resistance 10 minutes after milrinone administration</time_frame>
    <description>The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Pulmonary Hypertension Due to Left Heart Disease</condition>
  <arm_group>
    <arm_group_label>Group IH(inhaled milrinone)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Iv(Intravenous milrinone)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Milrinone inhalation</intervention_name>
    <description>After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered</description>
    <arm_group_label>Group IH(inhaled milrinone)</arm_group_label>
    <other_name>primacor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Milrinone infusion</intervention_name>
    <description>After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered</description>
    <arm_group_label>Group Iv(Intravenous milrinone)</arm_group_label>
    <other_name>primacor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled to undergo mitral valve surgery by cardiopulmonary bypass with&#xD;
             estimated mean pulmonary artery pressure =&gt;55 estimated by using preoperative Doppler&#xD;
             echocardiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients were excluded if they had surgery without CPB, preoperative hemodynamic&#xD;
        instability (deﬁned as acute requirement for vasoactive support or mechanical&#xD;
        device),Patients with severe LV dysfunction (LV ejection fraction of less than 30%&#xD;
        congenital heart disease, a contraindication to transesophageal echocardiography (TEE),&#xD;
        emergency surgery or re-do surgeries severe renal or hepatic disease&#xD;
&#xD;
        , coagulopathy, and thromboembolic disease treated with anticoagulants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heba M EL-Asser, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zagazig University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heba M EL-Asser, MD</last_name>
    <phone>01062393152</phone>
    <email>aseelaswad1@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amany S abdelazeem, MD</last_name>
    <phone>01287220016</phone>
    <email>dola.salah2009@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zagazig University</name>
      <address>
        <city>Zagazig</city>
        <state>Sharkia</state>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heba M Elasser, MD</last_name>
      <phone>01062393152</phone>
      <email>aseelaswad1@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Denault AY, Bussieres JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQN, Varin F, Fortier A, Levesque S, Shi Y, Elmi-Sarabi M, Tardif JC, Perrault LP, Lambert J. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients. Can J Anaesth. 2016 Oct;63(10):1140-1153. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28.</citation>
    <PMID>27470232</PMID>
  </reference>
  <reference>
    <citation>Wang H, Gong M, Zhou B, Dai A. Comparison of inhaled and intravenous milrinone in patients with pulmonary hypertension undergoing mitral valve surgery. Adv Ther. 2009 Apr;26(4):462-8. doi: 10.1007/s12325-009-0019-4. Epub 2009 Apr 16.</citation>
    <PMID>19381522</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Heba Mohamed EL -Asser,MD</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Milrinone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04484675
org study id: milrinone in cardiadc surgery
nct id: NCT04484675
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigator compared difference between inhaled and intravenous milirinone in patiens
      with severe pulmonary hypertension undergoing cardiac surgery
Milrinone is widely used in cardiac surgery as an inotrope and pulmonary vasodilator agent
      But , intravenous milrinone has been associated with systemic hypotension and increased
      requirement for vasoactive drugs

      The investigator compared difference between inhaled and intravenous milirinone in patiens
      with severe pulmonary hypertension undergoing cardiac surgery
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.
measure: mean arterial pressure
time frame: change in mean arterial pressure is recorded 10 minutes after milrinone administration after induction (T1), at the end of nebulization (T2), before cardiopulmonary bypass (T3) and after cardiopulmonary bypass(T4)
description: The effect of inhaled milrinone on mean arterial pressure is compared with the effect of intravenous milrinone
measure: mean pulmonary arterial pressure
time frame: change in mean pulmonary arterial pressure 10 minutes after milrinone administration
description: The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone
measure: systemic vascular resistance
time frame: change in systemic vascular resistance 10 minutes after milrinone administration
description: The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone
measure: pulmonary vascular resistance
time frame: change in pulmonary vascular resistance 10 minutes after milrinone administration
description: The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone
arm group label: Group IH(inhaled milrinone)
arm group type: Active Comparator
description: After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered
arm group label: Group Iv(Intravenous milrinone)
arm group type: Active Comparator
description: After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered
intervention type: Drug
intervention name: Milrinone inhalation
description: After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered
arm group label: Group IH(inhaled milrinone)
other name: primacor
intervention type: Drug
intervention name: Milrinone infusion
description: After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered
arm group label: Group Iv(Intravenous milrinone)
other name: primacor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heba M EL-Asser, MD
role: Principal Investigator
affiliation: Zagazig University
last name: Heba M EL-Asser, MD
phone: 01062393152
email: aseelaswad1@yahoo.com
last name: Amany S abdelazeem, MD
phone: 01287220016
email: dola.salah2009@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Denault AY, Bussieres JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQN, Varin F, Fortier A, Levesque S, Shi Y, Elmi-Sarabi M, Tardif JC, Perrault LP, Lambert J. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients. Can J Anaesth. 2016 Oct;63(10):1140-1153. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28.
PMID: 27470232
citation: Wang H, Gong M, Zhou B, Dai A. Comparison of inhaled and intravenous milrinone in patients with pulmonary hypertension undergoing mitral valve surgery. Adv Ther. 2009 Apr;26(4):462-8. doi: 10.1007/s12325-009-0019-4. Epub 2009 Apr 16.
PMID: 19381522
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Heba Mohamed EL -Asser,MD
investigator title: principal investigator
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Heart Diseases
mesh term: Milrinone
sharing ipd: No