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/NCT05970770</url>
    </required_header>
    <id_info>
      <org_study_id>HPI vs NIBP</org_study_id>
      <nct_id>NCT05970770</nct_id>
    </id_info>
    <brief_title>Hypotension Prediction Index vs Norepinephrine Infusion for Prevention of Spinal Hypotension for Cesarean Delivery</brief_title>
    <official_title>Hypotension Prediction Index Therapy is Non-inferior to Continuous Norepinephrine Infusion for Fetal Wellbeing in the Prevention of Spinal Anesthesia-Induced Hypotension for Cesarean Delivery: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized controlled trial is to compare for non inferiority for fetal&#xD;
        wellbeing Hypotension Prediction Index - Guided Therapy and Continuous Norepinephrine&#xD;
        Infusion in in the Prevention of Spinal Anesthesia-Induced Hypotension for Cesarean Delivery.&#xD;
  &#xD;
        The main question it aims to answer are:&#xD;
  &#xD;
        • are fetal arterial base excess comparable with the two treatments?&#xD;
  &#xD;
        Participants will undergo continuous noninvasive hemodynamic monitoring with advanced&#xD;
        Hypotension Prediction Index Researchers will compare with patients receiving continuous&#xD;
        norepinephrine infusion and standard blood pressure monitoring with arm cuff.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the Hypotension Prediction Index group, patients will be monitored continuously with a&#xD;
        noninvasive hemodynamic device. The Hypotension Prediction Index is a number based on al&#xD;
        algorithm that predicts impeding hypotension if it is greater than 85. In the treatment&#xD;
        group, patients will be treated with norepinephrine boluses if the Hypotension Prediction&#xD;
        Index is &gt;85. In the control group patients will be treated with preventive continuous&#xD;
        infusion of norepinephrine and blood pressure will be measured noninvasively every minute.&#xD;
        Data about blood pressure and the vasopressive treatment will start concomitantly to the&#xD;
        administration of spinal anesthesia and will stop after delivery. blood gas samples will be&#xD;
        then collected from the placental umbilical artery to compare fetal arterial base excess as&#xD;
        primary outcome for non-inferiority.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fetal Base excess</measure>
      <time_frame>at birth</time_frame>
      <description>withdrawn from umbilical fetal artery as index of perioperative metabolic acidosis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hypotensive episodes</measure>
      <time_frame>from spinal anesthesia until delivery</time_frame>
      <description>(sistolic blood pressure &lt;80% of baseline values for &lt;1 minute)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total vasopressor dose</measure>
      <time_frame>from spinal anesthesia until delivery</time_frame>
      <description>total dose of micrograms administered during operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hypertensive episodes</measure>
      <time_frame>from spinal anesthesia until delivery</time_frame>
      <description>systolic blood pressure &gt;140 mmHg and/or diastolic blood pressure &gt;100 mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fetal arterial pH</measure>
      <time_frame>at birth</time_frame>
      <description>value of fetal ph at the analisys from umbilical artery withdrown at birth</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apgar score</measure>
      <time_frame>at 5 minutes from birth</time_frame>
      <description>Apgar is a quick test performed on a baby at 1 and 5 minutes after birth, examines the baby's breathing effort, heart rate, muscle tone, reflexes, skin color. Each category is scored with 0, 1, or 2, depending on the observed condition. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Hypotension During Surgery</condition>
    <condition>Hypotension Drug-Induced</condition>
    <arm_group>
      <arm_group_label>Hypotension Prediction Index</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be monitored with Hypotension Prediction Index which will guide vasopressor therapy with boluses of norepinephrine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non Invasive Blood Pressure</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Spinal-induced hypotension will be prevented by continuous preventive norepinephrine infusion and blood pressure will be monitored by non invasive arm cuff every minute</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Hypotension Prediction Index</intervention_name>
      <description>in addition to standard monitoring, will have hemodynamic monitoring using HemoSphere (Edwards Lifesciences, Irvine, CA; internal memory 60 gigabyte, 10 gigabyte used for operating system) with ClearSight non-invasive hemodynamic monitoring and with the Hypotension Prediction Index software enabled. They will not receive preventive vasopressors but only norepinephrine boluses if Hypotension Prediction Index &gt;85</description>
      <arm_group_label>Hypotension Prediction Index</arm_group_label>
      <other_name>HemoSphere</other_name>
      <other_name>Clearsight</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Norepinephrine</intervention_name>
      <description>Patients in the HPI group will receive a norepinephrine bolus when HPI is below 85</description>
      <arm_group_label>Hypotension Prediction Index</arm_group_label>
      <arm_group_label>Non Invasive Blood Pressure</arm_group_label>
      <other_name>noradrenaline</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women between the 36th and the 40th week of gestation undergoing spinal&#xD;
               anesthesia for elective caesarian delivery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  preeclampsia;&#xD;
  &#xD;
            -  eclampsia;&#xD;
  &#xD;
            -  atrial fibrillation and sinus tachycardia;&#xD;
  &#xD;
            -  cardiovascular diseases;&#xD;
  &#xD;
            -  neuromuscular disease;&#xD;
  &#xD;
            -  emergent or urgent cesarean delivery;&#xD;
  &#xD;
            -  coagulopathies;&#xD;
  &#xD;
            -  contraindications to spinal anesthesia.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>pregnant women at term</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gaetano A Draisci, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>IRCCS fondazione policlinico universitario A. Gemelli</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chiara Sonnino, MD</last_name>
      <phone>+390630153105</phone>
      <email>chiara.sonnino@policlinicogemelli.it</email>
    </overall_contact>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 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>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>
    <!-- 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/NCT05970770
  org study id: HPI vs NIBP
  nct id: NCT05970770
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: Yes
  is us export: Yes
  The goal of this randomized controlled trial is to compare for non inferiority for fetal
        wellbeing Hypotension Prediction Index - Guided Therapy and Continuous Norepinephrine
        Infusion in in the Prevention of Spinal Anesthesia-Induced Hypotension for Cesarean Delivery.
  
        The main question it aims to answer are:
  
        • are fetal arterial base excess comparable with the two treatments?
  
        Participants will undergo continuous noninvasive hemodynamic monitoring with advanced
        Hypotension Prediction Index Researchers will compare with patients receiving continuous
        norepinephrine infusion and standard blood pressure monitoring with arm cuff.
  In the Hypotension Prediction Index group, patients will be monitored continuously with a
        noninvasive hemodynamic device. The Hypotension Prediction Index is a number based on al
        algorithm that predicts impeding hypotension if it is greater than 85. In the treatment
        group, patients will be treated with norepinephrine boluses if the Hypotension Prediction
        Index is >85. In the control group patients will be treated with preventive continuous
        infusion of norepinephrine and blood pressure will be measured noninvasively every minute.
        Data about blood pressure and the vasopressive treatment will start concomitantly to the
        administration of spinal anesthesia and will stop after delivery. blood gas samples will be
        then collected from the placental umbilical artery to compare fetal arterial base excess as
        primary outcome for non-inferiority.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Fetal Base excess
  time frame: at birth
  description: withdrawn from umbilical fetal artery as index of perioperative metabolic acidosis
  measure: Hypotensive episodes
  time frame: from spinal anesthesia until delivery
  description: (sistolic blood pressure <80% of baseline values for <1 minute)
  measure: Total vasopressor dose
  time frame: from spinal anesthesia until delivery
  description: total dose of micrograms administered during operation
  measure: Hypertensive episodes
  time frame: from spinal anesthesia until delivery
  description: systolic blood pressure >140 mmHg and/or diastolic blood pressure >100 mmHg
  measure: Fetal arterial pH
  time frame: at birth
  description: value of fetal ph at the analisys from umbilical artery withdrown at birth
  measure: Apgar score
  time frame: at 5 minutes from birth
  description: Apgar is a quick test performed on a baby at 1 and 5 minutes after birth, examines the baby's breathing effort, heart rate, muscle tone, reflexes, skin color. Each category is scored with 0, 1, or 2, depending on the observed condition. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.
  arm group label: Hypotension Prediction Index
  arm group type: Experimental
  description: Patients will be monitored with Hypotension Prediction Index which will guide vasopressor therapy with boluses of norepinephrine
  arm group label: Non Invasive Blood Pressure
  arm group type: Active Comparator
  description: Spinal-induced hypotension will be prevented by continuous preventive norepinephrine infusion and blood pressure will be monitored by non invasive arm cuff every minute
  intervention type: Device
  intervention name: Hypotension Prediction Index
  description: in addition to standard monitoring, will have hemodynamic monitoring using HemoSphere (Edwards Lifesciences, Irvine, CA; internal memory 60 gigabyte, 10 gigabyte used for operating system) with ClearSight non-invasive hemodynamic monitoring and with the Hypotension Prediction Index software enabled. They will not receive preventive vasopressors but only norepinephrine boluses if Hypotension Prediction Index >85
  arm group label: Hypotension Prediction Index
  other name: HemoSphere
  other name: Clearsight
  intervention type: Drug
  intervention name: Norepinephrine
  description: Patients in the HPI group will receive a norepinephrine bolus when HPI is below 85
  arm group label: Hypotension Prediction Index
  arm group label: Non Invasive Blood Pressure
  other name: noradrenaline
  criteria: 
  gender: Female
  gender based: Yes
  gender description: pregnant women at term
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Gaetano A Draisci, Prof
  role: Principal Investigator
  affiliation: IRCCS fondazione policlinico universitario A. Gemelli
  last name: Chiara Sonnino, MD
  phone: +390630153105
  email: chiara.sonnino@policlinicogemelli.it
  responsible party type: Sponsor
  mesh term: Hypotension
  mesh term: Norepinephrine