<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/NCT02258984</url>
  </required_header>
  <id_info>
    <org_study_id>1407013246</org_study_id>
    <nct_id>NCT02258984</nct_id>
  </id_info>
  <brief_title>Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial</brief_title>
  <official_title>Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mespere Lifesciences Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mespere Lifesciences Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the impact that the Venus 1000 non-invasive CVP&#xD;
      system has on the management of emergency department (ED) patients with fluid sensitive&#xD;
      conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ability to non-invasively, accurately, and continuously measure CVP to assess the preload&#xD;
      status of ED patients could lead to its inclusion into existing protocols (similar to EGDT),&#xD;
      or the development of novel protocols for the treatment of patients with fluid sensitive&#xD;
      conditions. The majority of other non-invasive measures of preload, such as ultrasound of the&#xD;
      inferior vena cava or the passive leg raise technique are not continuous measures and require&#xD;
      some type of effort or skill on the part of the clinician. Continuous methods of assessing&#xD;
      preload include CVP measurement through a central venous catheter, esophageal Doppler&#xD;
      monitoring, and pulse contour analysis via arterial catheter monitoring, all of which involve&#xD;
      invasive procedures.&#xD;
&#xD;
      The Venus CVP device is non-invasive and has continuous monitoring capabilities. The data&#xD;
      acquired from this project will allow us to determine whether emergency physicians will, in&#xD;
      practice, utilize the information provided by a non-invasive CVP monitoring device to assist&#xD;
      in the management of their patients with severe sepsis or acute HF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">November 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>30-day Readmission</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total amount of IV fluid administered over hospitalization</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose, timing and duration of all IV vasoactive medications</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in hospital</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of respiratory support</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rapid response activations</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality (in hospital, 7-day, 30-day)</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of repeat ED visits through 30 days post-discharge</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Severe Sepsis</condition>
  <condition>Acute Heart Failure</condition>
  <arm_group>
    <arm_group_label>Open physician access to Venus 1000 CVP data</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No open physician access to Venus 1000 CVP data</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mespere Venus 1000 Non-Invasive CVP System</intervention_name>
    <description>The Venus 1000 CVP System is a non-invasive central venous pressure measurement system that utilizes the proven science of NIRS. Approved by FDA, received Health Canada Medical Device Licence and CE Marked, the Venus 1000 has been proven to be clinically equivalent to measurements made via right heart catheterization.</description>
    <arm_group_label>No open physician access to Venus 1000 CVP data</arm_group_label>
    <arm_group_label>Open physician access to Venus 1000 CVP data</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years old or greater&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Clinical diagnosis of: 1) Severe Sepsis, or 2) Acute Heart Failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Traumatic injuries&#xD;
&#xD;
          -  Active bleeding&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Central venous catheter placement in the internal jugular or subclavian veins&#xD;
&#xD;
          -  Bilateral external jugular vein catheterizations&#xD;
&#xD;
          -  Concurrent enrollment into an interventional clinical trial that may affect subject&#xD;
             treatment&#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>Mark Favot, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wayne State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philip Levy, MD, FACEP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wayne State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Detroit Receiving Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>September 25, 2015</last_update_submitted>
  <last_update_submitted_qc>September 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 28, 2015</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>
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- 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/NCT02258984
org study id: 1407013246
nct id: NCT02258984
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the impact that the Venus 1000 non-invasive CVP
      system has on the management of emergency department (ED) patients with fluid sensitive
      conditions.
The ability to non-invasively, accurately, and continuously measure CVP to assess the preload
      status of ED patients could lead to its inclusion into existing protocols (similar to EGDT),
      or the development of novel protocols for the treatment of patients with fluid sensitive
      conditions. The majority of other non-invasive measures of preload, such as ultrasound of the
      inferior vena cava or the passive leg raise technique are not continuous measures and require
      some type of effort or skill on the part of the clinician. Continuous methods of assessing
      preload include CVP measurement through a central venous catheter, esophageal Doppler
      monitoring, and pulse contour analysis via arterial catheter monitoring, all of which involve
      invasive procedures.

      The Venus CVP device is non-invasive and has continuous monitoring capabilities. The data
      acquired from this project will allow us to determine whether emergency physicians will, in
      practice, utilize the information provided by a non-invasive CVP monitoring device to assist
      in the management of their patients with severe sepsis or acute HF.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: 30-day Readmission
time frame: 30 days
measure: Total amount of IV fluid administered over hospitalization
time frame: 30 days
measure: Dose, timing and duration of all IV vasoactive medications
time frame: 30 days
measure: Length of stay in hospital
time frame: 30 days
measure: Duration of respiratory support
time frame: 30 days
measure: Rapid response activations
time frame: 30 days
measure: Mortality (in hospital, 7-day, 30-day)
time frame: 30 days
measure: Number of repeat ED visits through 30 days post-discharge
time frame: 30 days
arm group label: Open physician access to Venus 1000 CVP data
arm group type: Other
arm group label: No open physician access to Venus 1000 CVP data
arm group type: Other
intervention type: Device
intervention name: Mespere Venus 1000 Non-Invasive CVP System
description: The Venus 1000 CVP System is a non-invasive central venous pressure measurement system that utilizes the proven science of NIRS. Approved by FDA, received Health Canada Medical Device Licence and CE Marked, the Venus 1000 has been proven to be clinically equivalent to measurements made via right heart catheterization.
arm group label: No open physician access to Venus 1000 CVP data
arm group label: Open physician access to Venus 1000 CVP data
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Favot, MD
role: Principal Investigator
affiliation: Wayne State University
last name: Philip Levy, MD, FACEP
role: Principal Investigator
affiliation: Wayne State University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Toxemia
mesh term: Heart Failure