xml: <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/NCT05997303</url>
    </required_header>
    <id_info>
      <org_study_id>2023-101053-BO-ff</org_study_id>
      <nct_id>NCT05997303</nct_id>
    </id_info>
    <brief_title>Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction</brief_title>
    <official_title>Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction - A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitätsklinikum Hamburg-Eppendorf</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>
        This is a randomized trial investigating whether continuous norepinephrine administration via&#xD;
        an infusion pump - compared to manual bolus administration - increases blood pressure&#xD;
        stability within the first 15 minutes of anesthetic induction in non-cardiac surgery&#xD;
        patients.&#xD;
  &#xD;
        The secondary endpoints area under a MAP of 65, 60, 50, and 40 mmHg [mmHg × min], cumulative&#xD;
        duration of a MAP &lt;65, &lt;60, &lt;50, and &lt;40 mmHg [min], area above a MAP of 100, 110, 120, and&#xD;
        140 mmHg [mmHg min], cumulative duration of a MAP &gt;100, &gt;110, &gt;120, and &gt;140 mmHg [min] and&#xD;
        cumulative dose of norepinephrine indexed to body weight [μg/kg] within the first 15 minutes&#xD;
        of anesthetic induction will be assessed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        not provided&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</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>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Blood pressure stability</measure>
      <time_frame>Measurement period of 15 minutes starting at the beginning of the anesthetic induction</time_frame>
      <description>Generalized average real variability (gARV) of mean arterial pressure (MAP) within the first 15 minutes of anesthetic induction [mmHg/min]; the gARV is the sum of absolute values of the differences between neighboring measurements for all measurements divided by the total measurement duration in [mmHg/min].</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Area under MAP</measure>
      <time_frame>Measurement period of 15 minutes starting at the beginning of the anesthetic induction</time_frame>
      <description>Area under a MAP of 65, 60, 50, and 40 mmHg [mmHg × min]. MAP will be measured using intraarterial blood pressure monitoring.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative duration of a MAP below</measure>
      <time_frame>Measurement period of 15 minutes starting at the beginning of the anesthetic induction</time_frame>
      <description>Cumulative duration of a MAP &lt;65, &lt;60, &lt;50, and &lt;40 mmHg [min]. MAP will be measured using intraarterial blood pressure monitoring.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area above MAP</measure>
      <time_frame>Measurement period of 15 minutes starting at the beginning of the anesthetic induction</time_frame>
      <description>Area above a MAP of 100, 110, 120, and 140 mmHg [mmHg × min]. MAP will be measured using intraarterial blood pressure monitoring.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative duration of a MAP above</measure>
      <time_frame>Measurement period of 15 minutes starting at the beginning of the anesthetic induction</time_frame>
      <description>Cumulative duration of a MAP &gt;100, &gt;110, &gt;120, and &gt;140 mmHg [min]. MAP will be measured using intraarterial blood pressure monitoring.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative dose of norepinephrine</measure>
      <time_frame>Measurement period of 15 minutes starting at the beginning of the anesthetic induction</time_frame>
      <description>Cumulative dose of norepinephrine indexed to body weight [μg/kg]</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Explorative aim - effect on (advanced) hemodynamic variables - stroke volume index</measure>
      <time_frame>Measurement period of 15 minutes starting at the beginning of the anesthetic induction</time_frame>
      <description>We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on stroke volume index [ml/m^2] using invasive uncalibrated pulse wave analysis (MostcareUP System).</description>
    </other_outcome>
    <other_outcome>
      <measure>Explorative aim - effect on (advanced) hemodynamic variables - heart rate</measure>
      <time_frame>Measurement period of 15 minutes starting at the beginning of the anesthetic induction</time_frame>
      <description>We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on heart rate [beats/minute] using invasive uncalibrated pulse wave analysis (MostcareUP System).</description>
    </other_outcome>
    <other_outcome>
      <measure>Explorative aim - effect on (advanced) hemodynamic variables - cardiac index</measure>
      <time_frame>Measurement period of 15 minutes starting at the beginning of the anesthetic induction</time_frame>
      <description>We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on cardiac index [l/min/m^2] using invasive uncalibrated pulse wave analysis (MostcareUP System).</description>
    </other_outcome>
    <other_outcome>
      <measure>Explorative aim - effect on (advanced) hemodynamic variables - systemic vascular resistance index</measure>
      <time_frame>Measurement period of 15 minutes starting at the beginning of the anesthetic induction</time_frame>
      <description>We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on systemic vascular resistance index [dyn × s × cm^-5 × m^2] using invasive uncalibrated pulse wave analysis (MostcareUP System).</description>
    </other_outcome>
    <other_outcome>
      <measure>Explorative aim - effect on (advanced) hemodynamic variables - pulse pressure variation</measure>
      <time_frame>Measurement period of 15 minutes starting at the beginning of the anesthetic induction</time_frame>
      <description>We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on pulse pressure variation [%] using invasive uncalibrated pulse wave analysis (MostcareUP System).</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Blood Pressure</condition>
    <condition>Perioperative Hypotension</condition>
    <arm_group>
      <arm_group_label>Continuous norepinephrine administration</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>continuous norepinephrine infusion via an infusion pump; norepinephrine dose will be at the discretion of the treating anesthesiologists</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Manual bolus norepinephrine administration</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>manual bolus norepinephrine administration; norepinephrine dose will be at the discretion of the treating anesthesiologists</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Continuous norepinephrine infusion via an infusion pump</intervention_name>
      <description>Patients will be randomized 1:1 to continuous norepinephrine infusion via an infusion pump or to manual bolus norepinephrine administration. The norepinephrine dose will be at the discretion of the treating anesthesiologists.</description>
      <arm_group_label>Continuous norepinephrine administration</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Manual bolus norepinephrine administration</intervention_name>
      <description>Patients will be randomized 1:1 to continuous norepinephrine infusion via an infusion pump or to manual bolus norepinephrine administration. The norepinephrine dose will be at the discretion of the treating anesthesiologists.</description>
      <arm_group_label>Manual bolus norepinephrine administration</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age ≥ 45 years&#xD;
  &#xD;
            -  American Society of Anesthesiologists physical status II-IV&#xD;
  &#xD;
            -  scheduled for elective major non-cardiac surgery under general anesthesia&#xD;
  &#xD;
            -  continuous intraarterial blood pressure monitoring using a radial arterial catheter&#xD;
               for clinical indications not related to the trial&#xD;
  &#xD;
            -  sinus rhythm&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Clinical indication to use a continuous norepinephrine infusion via an infusion pump&#xD;
               during anesthetic induction&#xD;
  &#xD;
            -  Need for femoral artery catheterization&#xD;
  &#xD;
            -  History of intracranial bleedings or aneurysms&#xD;
  &#xD;
            -  Patients who are incapable of giving consent&#xD;
  &#xD;
            -  Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christina Vokuhl, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christina Vokuhl, M.D.</last_name>
      <phone>+49 15222827456</phone>
      <email>c.vokuhl@uke.de</email>
    </overall_contact>
    <location>
      <facility>
        <name>Universitätsklinikum Hamburg-Eppendorf</name>
        <address>
          <city>Hamburg</city>
          <zip>20251</zip>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Christina Vokuhl, M.D.</last_name>
        <email>c.vokuhl@uke.de</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>blood pressure stability</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypotension</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>
  
  
text: 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/NCT05997303
  org study id: 2023-101053-BO-ff
  nct id: NCT05997303
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized trial investigating whether continuous norepinephrine administration via
        an infusion pump - compared to manual bolus administration - increases blood pressure
        stability within the first 15 minutes of anesthetic induction in non-cardiac surgery
        patients.
  
        The secondary endpoints area under a MAP of 65, 60, 50, and 40 mmHg [mmHg × min], cumulative
        duration of a MAP <65, <60, <50, and <40 mmHg [min], area above a MAP of 100, 110, 120, and
        140 mmHg [mmHg min], cumulative duration of a MAP >100, >110, >120, and >140 mmHg [min] and
        cumulative dose of norepinephrine indexed to body weight [μg/kg] within the first 15 minutes
        of anesthetic induction will be assessed.
  not provided
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Blood pressure stability
  time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
  description: Generalized average real variability (gARV) of mean arterial pressure (MAP) within the first 15 minutes of anesthetic induction [mmHg/min]; the gARV is the sum of absolute values of the differences between neighboring measurements for all measurements divided by the total measurement duration in [mmHg/min].
  measure: Area under MAP
  time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
  description: Area under a MAP of 65, 60, 50, and 40 mmHg [mmHg × min]. MAP will be measured using intraarterial blood pressure monitoring.
  measure: Cumulative duration of a MAP below
  time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
  description: Cumulative duration of a MAP <65, <60, <50, and <40 mmHg [min]. MAP will be measured using intraarterial blood pressure monitoring.
  measure: Area above MAP
  time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
  description: Area above a MAP of 100, 110, 120, and 140 mmHg [mmHg × min]. MAP will be measured using intraarterial blood pressure monitoring.
  measure: Cumulative duration of a MAP above
  time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
  description: Cumulative duration of a MAP >100, >110, >120, and >140 mmHg [min]. MAP will be measured using intraarterial blood pressure monitoring.
  measure: Cumulative dose of norepinephrine
  time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
  description: Cumulative dose of norepinephrine indexed to body weight [μg/kg]
  measure: Explorative aim - effect on (advanced) hemodynamic variables - stroke volume index
  time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
  description: We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on stroke volume index [ml/m^2] using invasive uncalibrated pulse wave analysis (MostcareUP System).
  measure: Explorative aim - effect on (advanced) hemodynamic variables - heart rate
  time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
  description: We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on heart rate [beats/minute] using invasive uncalibrated pulse wave analysis (MostcareUP System).
  measure: Explorative aim - effect on (advanced) hemodynamic variables - cardiac index
  time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
  description: We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on cardiac index [l/min/m^2] using invasive uncalibrated pulse wave analysis (MostcareUP System).
  measure: Explorative aim - effect on (advanced) hemodynamic variables - systemic vascular resistance index
  time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
  description: We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on systemic vascular resistance index [dyn × s × cm^-5 × m^2] using invasive uncalibrated pulse wave analysis (MostcareUP System).
  measure: Explorative aim - effect on (advanced) hemodynamic variables - pulse pressure variation
  time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
  description: We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on pulse pressure variation [%] using invasive uncalibrated pulse wave analysis (MostcareUP System).
  arm group label: Continuous norepinephrine administration
  arm group type: Other
  description: continuous norepinephrine infusion via an infusion pump; norepinephrine dose will be at the discretion of the treating anesthesiologists
  arm group label: Manual bolus norepinephrine administration
  arm group type: Other
  description: manual bolus norepinephrine administration; norepinephrine dose will be at the discretion of the treating anesthesiologists
  intervention type: Other
  intervention name: Continuous norepinephrine infusion via an infusion pump
  description: Patients will be randomized 1:1 to continuous norepinephrine infusion via an infusion pump or to manual bolus norepinephrine administration. The norepinephrine dose will be at the discretion of the treating anesthesiologists.
  arm group label: Continuous norepinephrine administration
  intervention type: Other
  intervention name: Manual bolus norepinephrine administration
  description: Patients will be randomized 1:1 to continuous norepinephrine infusion via an infusion pump or to manual bolus norepinephrine administration. The norepinephrine dose will be at the discretion of the treating anesthesiologists.
  arm group label: Manual bolus norepinephrine administration
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christina Vokuhl, M.D.
  role: Principal Investigator
  affiliation: Universitätsklinikum Hamburg-Eppendorf
  last name: Christina Vokuhl, M.D.
  phone: +49 15222827456
  email: c.vokuhl@uke.de
  facility: 
  contact: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Hypotension
  mesh term: Norepinephrine
  sharing ipd: No