<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/NCT03805217</url>
  </required_header>
  <id_info>
    <org_study_id>2018-15</org_study_id>
    <nct_id>NCT03805217</nct_id>
  </id_info>
  <brief_title>Hypotension Prediction Index Study (HPI Study)</brief_title>
  <official_title>Prospective, Single-Arm, Open-Label, Multicenter Study of Hypotension Prevention and Treatment in Patients Receiving Arterial Pressure Monitoring With Acumen™ Hypotension Prediction Index Feature Software</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Edwards Lifesciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</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>
      A prospective, single-arm, open-label, multicenter post-approval study to determine whether&#xD;
      the use of the Acumen HPI Software to guide intraoperative hemodynamic management in&#xD;
      non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of&#xD;
      Mean Arterial Pressure (MAP)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 16, 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of Intraoperative Hypotension</measure>
    <time_frame>Duration of Surgery</time_frame>
    <description>Duration (t [min]) reduction of intraoperative hypotension (defined as MAP &lt; 65 mmHg for at least 1 minute) as compared with a historic retrospective control group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative Hypotension in Each Subject</measure>
    <time_frame>Duration of Surgery</time_frame>
    <description>The determination of total area under the curve (time and MAP) for Intraoperative Hypotension in each subject. This endpoint is correlated with the duration and a descriptive analysis of this endpoint will be presented with the mean, standard deviation, median, minimum and maximum.</description>
  </secondary_outcome>
  <enrollment type="Actual">485</enrollment>
  <condition>Hypotension</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software</intervention_name>
    <description>EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects recruited and enrolled should be classified as American Society of&#xD;
        Anesthesiologist (ASA) physical status 3-4 who are scheduled for moderate-to-high-risk&#xD;
        non-cardiac surgery and will be receiving pressure monitoring with an arterial line.&#xD;
        Potentially qualifying patients will be evaluated during their preoperative anesthesia&#xD;
        clinic visits.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent;&#xD;
&#xD;
          2. Age ≥ 18 years;&#xD;
&#xD;
          3. ASA Physical Status 3 or 4;&#xD;
&#xD;
          4. Moderate- or high-risk non-cardiac surgery (for example, orthopedic, spine, urology,&#xD;
             and general surgery);&#xD;
&#xD;
          5. Planned pressure monitoring with an arterial line;&#xD;
&#xD;
          6. General anesthesia;&#xD;
&#xD;
          7. Surgery duration expected to last ≥ 3 hours from induction;&#xD;
&#xD;
          8. Planned overnight hospitalization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participating in another (interventional) study;&#xD;
&#xD;
          2. Contraindication to the invasive blood pressure monitoring;&#xD;
&#xD;
          3. Patient who is confirmed to be pregnant and/or nursing mothers;&#xD;
&#xD;
          4. Emergency surgery;&#xD;
&#xD;
          5. Known clinically important intra-cardiac shunts;&#xD;
&#xD;
          6. Patient in whom an intraoperative MAP target will be &lt; 65 mmHg;&#xD;
&#xD;
          7. Known aortic stenosis with valve area ≤ 1.5 cm2;&#xD;
&#xD;
          8. Known moderate to severe aortic regurgitation;&#xD;
&#xD;
          9. Known moderate to severe mitral regurgitation;&#xD;
&#xD;
         10. Known moderate to severe mitral stenosis;&#xD;
&#xD;
         11. Patient or surgical procedure type known as an SVV limitation (5) (e.g. tidal volume&#xD;
             &lt;8mL/kg of theoretical ideal weight, spontaneous ventilation, persistent cardiac&#xD;
             arrhythmia, known atrial fibrillation, open chest surgery, Heart Rate/Respiratory Rate&#xD;
             (HR/RR) ratio &lt;3.6);&#xD;
&#xD;
         12. Current persistent atrial fibrillation;&#xD;
&#xD;
         13. Known acute congestive heart failure;&#xD;
&#xD;
         14. Craniotomy;&#xD;
&#xD;
         15. Surgery duration expected to last &lt; 3 hours;&#xD;
&#xD;
         16. Burn surgeries;&#xD;
&#xD;
         17. Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);&#xD;
&#xD;
         18. Patient transfer from ICU requiring multiple vasoactive agents and known diagnosis of&#xD;
             ongoing active sepsis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford Health Care</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCHealth University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</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>
  <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/NCT03805217
org study id: 2018-15
nct id: NCT03805217
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
A prospective, single-arm, open-label, multicenter post-approval study to determine whether
      the use of the Acumen HPI Software to guide intraoperative hemodynamic management in
      non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of
      Mean Arterial Pressure (MAP)
observational model: Other
time perspective: Prospective
measure: Reduction of Intraoperative Hypotension
time frame: Duration of Surgery
description: Duration (t [min]) reduction of intraoperative hypotension (defined as MAP < 65 mmHg for at least 1 minute) as compared with a historic retrospective control group
measure: Intraoperative Hypotension in Each Subject
time frame: Duration of Surgery
description: The determination of total area under the curve (time and MAP) for Intraoperative Hypotension in each subject. This endpoint is correlated with the duration and a descriptive analysis of this endpoint will be presented with the mean, standard deviation, median, minimum and maximum.
intervention type: Device
intervention name: EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
description: EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypotension
sharing ipd: No