<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/NCT03806582</url>
  </required_header>
  <id_info>
    <org_study_id>TPO 1051</org_study_id>
    <nct_id>NCT03806582</nct_id>
  </id_info>
  <brief_title>Effect of a Higher Blood-pressure on Right Ventricular Function</brief_title>
  <official_title>Effect of a Higher Blood-pressure on Right Ventricular Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical Centre Leeuwarden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical Centre Leeuwarden</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>
      Right ventricular (RV) dysfunction in cardiac surgery is an independent risk factor for&#xD;
      morbidity and mortality. Raising the systemic blood pressure with norepinephrine seems to&#xD;
      have a positive influence on the right ventricular function in several animal studies. The&#xD;
      current study is designed to evaluate the effect of a higher blood pressure on the RV&#xD;
      function in post cardiac surgery patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Goal: To demonstrate differences in RV function by raising the systemic blood pressure with&#xD;
      norepinephrine.&#xD;
&#xD;
      Study design: randomized controlled trial Study population: 78 postoperative cardiac surgery&#xD;
      patients admitted at the ICU.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
        -  Group 1: (N=22): RVEF&lt;20% and MAP≤65mmHg. Intervention with norepinephrine to reach a&#xD;
           MAP of 85mmHg for a maximum duration of two hours.&#xD;
&#xD;
        -  Group 2: (N=22): RVEF &lt;20% and MAP≤65mmHg. Control group: treatment according to current&#xD;
           standards. Hypotensive patients are treated with fluids and/or vasopressors to gain a&#xD;
           mean arterial pressure (MAP) of 65mmHg.&#xD;
&#xD;
        -  Group 3: (N=17): RVEF between ≥20 and &lt;30% and MAP ≤65mmHg. Intervention with&#xD;
           norepinephrine to reach a MAP of 85mmHg for a maximum duration of two hours.&#xD;
&#xD;
        -  Group 4: (N=17): RVEF between ≥20 and &lt;30% and MAP ≤65mmHg. Control group: treatment&#xD;
           according to current standards. Hypotensive patients are treated with fluids and/or&#xD;
           vasopressors to gain a mean arterial pressure (MAP) of 65mmHg.&#xD;
&#xD;
      Endpoints: Primary endpoint is the difference between the intervention and the control group&#xD;
      in the change over time between baseline and the end of the study period (T4) in RVEF.&#xD;
      Secondary endpoints are the echocardiographic parameters of RV and LV contractility, RV&#xD;
      end-diastolic pressure, cardiac index, and fluid balance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">May 25, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>open label study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>right ventricular ejection fraction</measure>
    <time_frame>2 hours postoperative</time_frame>
    <description>Primary endpoint is the difference between the intervention and the control group in the change over time between baseline and the end of the study period (T4) in RVEF.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic</measure>
    <time_frame>2 hours postoperative</time_frame>
    <description>Echocardiographic parameters of RV and LV contractility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RV end-diastolic pressure</measure>
    <time_frame>baseline and 15 minutes postoperatively</time_frame>
    <description>RV end-diastolic pressure pre and post intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac index</measure>
    <time_frame>2 hours postoperative</time_frame>
    <description>Difference in cardiac index between intervention and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluid balance</measure>
    <time_frame>2 hours postoperative</time_frame>
    <description>Difference in fluid balance between intervention and control groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Right Ventricular Dysfunction</condition>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intervention with norepinephrine to reach a MAP of 85 mmHg for a maximum duration of 1 hour, observation of the effect on right ventricular function</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group; treatment according to current standards, observation of the effect on right ventricular function</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine</intervention_name>
    <description>intervention with norepinephrine to reach a MAP of 85 mmHg</description>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  post operative cardiac surgery patients, full sternotomy&#xD;
&#xD;
          -  admission at ICU&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  right ventricular monitoring by pulmonary artery catheter.&#xD;
&#xD;
          -  RVEF &lt;30% + MAP ≤ 65mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no informed consent&#xD;
&#xD;
          -  acute surgery&#xD;
&#xD;
          -  Off pump cardiac surgery&#xD;
&#xD;
          -  Severe tricuspid insufficiency&#xD;
&#xD;
          -  Allergy to norepinephrine&#xD;
&#xD;
          -  Severe left ventricular hypertrophy with systolic anterior movement&#xD;
&#xD;
          -  Chronic use of alpha-blockers&#xD;
&#xD;
          -  Irregulair heart rhythm&#xD;
&#xD;
          -  Surgical reasons to maintain a low blood pressure.&#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>Christiaan Boerma, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Centre Leeuwarden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Center Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <zip>8904 BR</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>October 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical Centre Leeuwarden</investigator_affiliation>
    <investigator_full_name>E.C. Boerma</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ventricular Dysfunction</mesh_term>
    <mesh_term>Ventricular Dysfunction, Right</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Norepinephrine</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/NCT03806582
org study id: TPO 1051
nct id: NCT03806582
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Right ventricular (RV) dysfunction in cardiac surgery is an independent risk factor for
      morbidity and mortality. Raising the systemic blood pressure with norepinephrine seems to
      have a positive influence on the right ventricular function in several animal studies. The
      current study is designed to evaluate the effect of a higher blood pressure on the RV
      function in post cardiac surgery patients.
Goal: To demonstrate differences in RV function by raising the systemic blood pressure with
      norepinephrine.

      Study design: randomized controlled trial Study population: 78 postoperative cardiac surgery
      patients admitted at the ICU.

      Intervention:

        -  Group 1: (N=22): RVEF<20% and MAP≤65mmHg. Intervention with norepinephrine to reach a
           MAP of 85mmHg for a maximum duration of two hours.

        -  Group 2: (N=22): RVEF <20% and MAP≤65mmHg. Control group: treatment according to current
           standards. Hypotensive patients are treated with fluids and/or vasopressors to gain a
           mean arterial pressure (MAP) of 65mmHg.

        -  Group 3: (N=17): RVEF between ≥20 and <30% and MAP ≤65mmHg. Intervention with
           norepinephrine to reach a MAP of 85mmHg for a maximum duration of two hours.

        -  Group 4: (N=17): RVEF between ≥20 and <30% and MAP ≤65mmHg. Control group: treatment
           according to current standards. Hypotensive patients are treated with fluids and/or
           vasopressors to gain a mean arterial pressure (MAP) of 65mmHg.

      Endpoints: Primary endpoint is the difference between the intervention and the control group
      in the change over time between baseline and the end of the study period (T4) in RVEF.
      Secondary endpoints are the echocardiographic parameters of RV and LV contractility, RV
      end-diastolic pressure, cardiac index, and fluid balance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
masking description: open label study
measure: right ventricular ejection fraction
time frame: 2 hours postoperative
description: Primary endpoint is the difference between the intervention and the control group in the change over time between baseline and the end of the study period (T4) in RVEF.
measure: Echocardiographic
time frame: 2 hours postoperative
description: Echocardiographic parameters of RV and LV contractility
measure: RV end-diastolic pressure
time frame: baseline and 15 minutes postoperatively
description: RV end-diastolic pressure pre and post intervention
measure: Cardiac index
time frame: 2 hours postoperative
description: Difference in cardiac index between intervention and control groups
measure: Fluid balance
time frame: 2 hours postoperative
description: Difference in fluid balance between intervention and control groups
arm group label: intervention
arm group type: Active Comparator
description: intervention with norepinephrine to reach a MAP of 85 mmHg for a maximum duration of 1 hour, observation of the effect on right ventricular function
arm group label: control
arm group type: No Intervention
description: control group; treatment according to current standards, observation of the effect on right ventricular function
intervention type: Drug
intervention name: Norepinephrine
description: intervention with norepinephrine to reach a MAP of 85 mmHg
arm group label: intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christiaan Boerma, Dr
role: Principal Investigator
affiliation: Medical Centre Leeuwarden
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Medical Centre Leeuwarden
investigator full name: E.C. Boerma
investigator title: Dr
mesh term: Ventricular Dysfunction
mesh term: Ventricular Dysfunction, Right
mesh term: Norepinephrine
sharing ipd: No