<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/NCT04501861</url>
  </required_header>
  <id_info>
    <org_study_id>20-301</org_study_id>
    <nct_id>NCT04501861</nct_id>
  </id_info>
  <brief_title>Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients:</brief_title>
  <official_title>Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients: a Comparative-effectiveness Quality Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The relative increase in the mPAP with the same unit increase in MAP adjusted for baseline,&#xD;
      and RV function assessed by GLS, between VP and NE in patients with normal and increased&#xD;
      pulmonary artery pressure, who require vasopressor support during cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific aims of our study are to compare 1) the relative increase in the mPAP with the&#xD;
      same unit increase in MAP adjusted for baseline and 2) RV function assessed by GLS, between&#xD;
      VP and NE in patients with normal and increased pulmonary artery pressure, who require&#xD;
      vasopressor support during cardiac surgery. We hypothesize that the use of vasopressin&#xD;
      compared with norepinephrine induces a lower mPAP-to-MAP ratio, in cardiac surgical patients&#xD;
      with and without pulmonary hypertension who require intraoperative vasopressor support.&#xD;
      Second, we will test the hypothesis that vasopressin is associated with improved right&#xD;
      ventricular global longitudinal strain compared to norepinephrine in patients requiring&#xD;
      vasopressor support during cardiac surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 5, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">August 22, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively.</measure>
    <time_frame>during surgery</time_frame>
    <description>Compare mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Cardiac Disease</condition>
  <arm_group>
    <arm_group_label>The use of vasopressin compared with norepinephrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The investigator hypothesize that the use of vasopressin compared with norepinephrine induces a lower mPAP-to-MAP ratio, in cardiac surgical patients with and without pulmonary hypertension who require intraoperative vasopressor support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The use of norepinephrine compared with vasopressin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The investigators will compare GLS between patients who received norepinephrine versus vasopressin intraoperatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine</intervention_name>
    <description>Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients</description>
    <arm_group_label>The use of norepinephrine compared with vasopressin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vasopressin</intervention_name>
    <description>Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients</description>
    <arm_group_label>The use of vasopressin compared with norepinephrine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Adults&gt; 18 years of age&#xD;
&#xD;
          -  Elective cardiac surgery with the use of CPB&#xD;
&#xD;
          -  Patients with pulmonary artery catheter insertion&#xD;
&#xD;
          -  Systemic hypotension (MAP &lt; 70 mmHg) requiring continuous infusion of vasopressor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transplant surgery&#xD;
&#xD;
          -  Ventricular assist device implantation other than intra-aortic balloon&#xD;
             counter-pulsation&#xD;
&#xD;
          -  Pulmonary endarterectomy&#xD;
&#xD;
          -  Thoracoabdominal aneurysm repair&#xD;
&#xD;
          -  Inhalational pulmonary vasodilators (e.g. Epoprostenol) administration before&#xD;
             insertion of pulmonary artery catheter&#xD;
&#xD;
          -  Vasopressin is started as the first choice of pressor per clinical staff discretion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mariya Geube, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vasopressins</mesh_term>
    <mesh_term>Arginine Vasopressin</mesh_term>
    <mesh_term>Norepinephrine</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/NCT04501861
org study id: 20-301
nct id: NCT04501861
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The relative increase in the mPAP with the same unit increase in MAP adjusted for baseline,
      and RV function assessed by GLS, between VP and NE in patients with normal and increased
      pulmonary artery pressure, who require vasopressor support during cardiac surgery.
The specific aims of our study are to compare 1) the relative increase in the mPAP with the
      same unit increase in MAP adjusted for baseline and 2) RV function assessed by GLS, between
      VP and NE in patients with normal and increased pulmonary artery pressure, who require
      vasopressor support during cardiac surgery. We hypothesize that the use of vasopressin
      compared with norepinephrine induces a lower mPAP-to-MAP ratio, in cardiac surgical patients
      with and without pulmonary hypertension who require intraoperative vasopressor support.
      Second, we will test the hypothesis that vasopressin is associated with improved right
      ventricular global longitudinal strain compared to norepinephrine in patients requiring
      vasopressor support during cardiac surgery.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively.
time frame: during surgery
description: Compare mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure.
arm group label: The use of vasopressin compared with norepinephrine
arm group type: Active Comparator
description: The investigator hypothesize that the use of vasopressin compared with norepinephrine induces a lower mPAP-to-MAP ratio, in cardiac surgical patients with and without pulmonary hypertension who require intraoperative vasopressor support.
arm group label: The use of norepinephrine compared with vasopressin
arm group type: Active Comparator
description: The investigators will compare GLS between patients who received norepinephrine versus vasopressin intraoperatively.
intervention type: Drug
intervention name: Norepinephrine
description: Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients
arm group label: The use of norepinephrine compared with vasopressin
intervention type: Drug
intervention name: Vasopressin
description: Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients
arm group label: The use of vasopressin compared with norepinephrine
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Mariya Geube, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Vasopressins
mesh term: Arginine Vasopressin
mesh term: Norepinephrine