<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/NCT03231956</url>
  </required_header>
  <id_info>
    <org_study_id>2017-04</org_study_id>
    <nct_id>NCT03231956</nct_id>
  </id_info>
  <brief_title>CLEAR Sepsis Clinical Study</brief_title>
  <acronym>CLEAR Sepsis</acronym>
  <official_title>Noninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)</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>
      To investigate the relationship between initial ClearSight™ derived hemodynamic parameters&#xD;
      and outcomes (death, ongoing organ dysfunction or delayed ICU admission) in patients with&#xD;
      acute infection and possible sepsis, with a focus on venous blood lactate (&lt; 2.0, 2.0-3.9,&#xD;
      and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor&#xD;
      infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic&#xD;
      Group).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 29, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Composite outcome</measure>
    <time_frame>Within 72 hours of presentation</time_frame>
    <description>Increase in modified Sequential Organ Failure Assessment (mSOFA) score ≥ 1 resulting in ICU admission / death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Venous Blood Lactate clearance</measure>
    <time_frame>Within 24 and 72 hours of presentation</time_frame>
    <description>Venous Blood Lactate clearance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>30 days</time_frame>
    <description>Emergency Department length of stay, ICU length of stay, and Hospital length of stay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recidivism</measure>
    <time_frame>30 days</time_frame>
    <description>Recidivism within 30 days of the index hospital visit</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">182</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Group 0</arm_group_label>
    <description>Control Sepsis Mimic Group (minor infections or asthma/COPD exacerbations) venous blood lactate levels are not required for this subgroup.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Suspected infection plus Initial Venous Blood Lactate ≥ 0 - 1.9 mmol/dL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Suspected infection plus Initial Venous Blood Lactate ≥ 2.0 - 3.9 mmol/dL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Suspected infection plus Initial Venous Blood Lactate ≥ 4.0 mmol/dL</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ClearSight™ / EV1000NI Clinical Platform</intervention_name>
    <description>Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System</description>
    <arm_group_label>Group 0</arm_group_label>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Laboratory specimens to be collected include blood and will be analyzed for lactate at a&#xD;
      central clinical research laboratory (WSU Integrative Biosciences, Detroit, MI).&#xD;
      Additionally, plasma samples will be obtained for and stored at the WSU Biobank to support&#xD;
      potential future clinical and translational research. Samples for the purpose of the WSU&#xD;
      Biobank are optional to the clinical research participant and will not adversely affect&#xD;
      participation in the clinical trial.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute infection and possible sepsis, with a focus on venous blood lactate (&lt;&#xD;
        2.0, 2.0-3.9, and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting&#xD;
        with minor infections or asthma/COPD exacerbations as controls (henceforth referred to as&#xD;
        Sepsis Mimic Group).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Venous Blood Lactate Groups&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years of age at the time of enrollment&#xD;
&#xD;
          -  Any combination of acute symptoms and signs that the treating ED physician, after&#xD;
             initial history and physical examination, attributes to a systemic infection&#xD;
&#xD;
          -  ED Physician confirms likely hospital admission (&gt; 50%) due to suspicion of infection&#xD;
&#xD;
          -  ED Physician confirms intention to order both blood cultures and venous blood lactate&#xD;
             levels&#xD;
&#xD;
          -  Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of&#xD;
             ED presentation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Initial venous blood lactate measured &gt; 3 hours after ED arrival&#xD;
&#xD;
          -  Pre-existing infection for which patient is being treated with antibiotics as an&#xD;
             outpatient&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Any previous medical condition with life expectancy of &lt; 3 months (patients with ESRD&#xD;
             and heart failure are not excluded)&#xD;
&#xD;
          -  DNR or comfort care order preexisting to ED visit or established in the ED&#xD;
&#xD;
          -  Palliative care or hospice consult in the ED&#xD;
&#xD;
          -  Known severe aortic insufficiency&#xD;
&#xD;
          -  Known history of Raynaud's disease&#xD;
&#xD;
          -  Poor follow-up candidate in the opinion of the Investigator&#xD;
&#xD;
          -  Current or planned enrollment in an investigational trial that in the opinion of the&#xD;
             Investigator may significantly affect hemodynamic data collection.&#xD;
&#xD;
        Control Sepsis Mimic&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age at the time of enrollment&#xD;
&#xD;
          -  Presents to the ED with a chief complaint consistent with a minor infection (upper&#xD;
             respiratory infection, soft tissue infection, viral infection) or an asthma or COPD&#xD;
             exacerbation on whom the treating physician is not ordering labs for blood cultures or&#xD;
             lactate levels&#xD;
&#xD;
          -  Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of&#xD;
             ED presentation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing infection for which patient is being treated with antibiotics as an&#xD;
             outpatient&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Any previous medical condition with life expectancy of &lt; 3 months (patients with ESRD&#xD;
             and heart failure are not excluded)&#xD;
&#xD;
          -  DNR or comfort care order preexisting to ED visit or established in the ED&#xD;
&#xD;
          -  Palliative care or hospice consult in the ED&#xD;
&#xD;
          -  Known severe aortic insufficiency&#xD;
&#xD;
          -  Known history of Raynaud's disease&#xD;
&#xD;
          -  Poor follow-up candidate in the opinion of the Investigator&#xD;
&#xD;
          -  Current or planned enrollment in an investigational trial that in the opinion of the&#xD;
             Investigator may significantly affect hemodynamic data collection.&#xD;
&#xD;
          -  Treating physician is planning on ordering either a lactate or blood cultures on the&#xD;
             patient.&#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_contact>
    <last_name>Jurandir Araujo, BA</last_name>
    <phone>949-250-5469</phone>
    <email>jurandir_araujo@edwards.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ryan Zafra, BS</last_name>
    <phone>949-250-1354</phone>
    <email>ryan_zafra@edwards.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Detroit Receiving Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Paxton, MD</last_name>
      <phone>313-993-8464</phone>
      <email>jpaxton@med.wayne.edu</email>
    </contact>
    <contact_backup>
      <last_name>Theodore Falcon</last_name>
      <phone>313-993-8464</phone>
      <email>tfalcon@med.wayne.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Sinai-Grace Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Sherwin, MD</last_name>
      <phone>313-966-9114</phone>
      <email>rshewin@med.wayne.edu</email>
    </contact>
    <contact_backup>
      <last_name>Joshua Phillips</last_name>
      <phone>313-966-9114</phone>
      <email>jphillip@med.wayne.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Ascension St. John Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire Pearson, MD</last_name>
      <phone>313-966-1829</phone>
      <email>cpearson@med.wayne.edu</email>
    </contact>
    <contact_backup>
      <last_name>Thomas Mazzocco</last_name>
      <phone>313-966-1829</phone>
      <email>tmazzocc@med.wayne.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital, Royal Oak</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48703</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital, Troy</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48085</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 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>Sepsis</mesh_term>
    <mesh_term>Toxemia</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/NCT03231956
org study id: 2017-04
nct id: NCT03231956
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
To investigate the relationship between initial ClearSight™ derived hemodynamic parameters
      and outcomes (death, ongoing organ dysfunction or delayed ICU admission) in patients with
      acute infection and possible sepsis, with a focus on venous blood lactate (< 2.0, 2.0-3.9,
      and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor
      infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic
      Group).
observational model: Case-Control
time perspective: Prospective
measure: Composite outcome
time frame: Within 72 hours of presentation
description: Increase in modified Sequential Organ Failure Assessment (mSOFA) score ≥ 1 resulting in ICU admission / death.
measure: Venous Blood Lactate clearance
time frame: Within 24 and 72 hours of presentation
description: Venous Blood Lactate clearance
measure: Length of Stay
time frame: 30 days
description: Emergency Department length of stay, ICU length of stay, and Hospital length of stay
measure: Recidivism
time frame: 30 days
description: Recidivism within 30 days of the index hospital visit
arm group label: Group 0
description: Control Sepsis Mimic Group (minor infections or asthma/COPD exacerbations) venous blood lactate levels are not required for this subgroup.
arm group label: Group 1
description: Suspected infection plus Initial Venous Blood Lactate ≥ 0 - 1.9 mmol/dL
arm group label: Group 2
description: Suspected infection plus Initial Venous Blood Lactate ≥ 2.0 - 3.9 mmol/dL
arm group label: Group 3
description: Suspected infection plus Initial Venous Blood Lactate ≥ 4.0 mmol/dL
intervention type: Device
intervention name: ClearSight™ / EV1000NI Clinical Platform
description: Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System
arm group label: Group 0
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
Laboratory specimens to be collected include blood and will be analyzed for lactate at a
      central clinical research laboratory (WSU Integrative Biosciences, Detroit, MI).
      Additionally, plasma samples will be obtained for and stored at the WSU Biobank to support
      potential future clinical and translational research. Samples for the purpose of the WSU
      Biobank are optional to the clinical research participant and will not adversely affect
      participation in the clinical trial.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jurandir Araujo, BA
phone: 949-250-5469
email: jurandir_araujo@edwards.com
last name: Ryan Zafra, BS
phone: 949-250-1354
email: ryan_zafra@edwards.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Terminated
facility: 
status: Terminated
country: United States
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Toxemia
sharing ipd: No