<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/NCT02221908</url>
  </required_header>
  <id_info>
    <org_study_id>IRB1401002513</org_study_id>
    <nct_id>NCT02221908</nct_id>
  </id_info>
  <brief_title>ED Decision Making Among Hypotensive Patients</brief_title>
  <official_title>ED Decision Making Among Hypotensive Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mespere Lifesciences Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mespere Lifesciences Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to assess decision making skills of emergency physicians when&#xD;
      dealing with hypotensive patients. The hypothesis is that decisions made based on physical&#xD;
      exam and vital signs regarding fluid resuscitation by emergency physicians are not&#xD;
      statistically equivalent to those that would be made based on the use of a non-invasive CVP&#xD;
      measurement&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If physicians can make appropriate decisions about the need for fluid resuscitation without&#xD;
      CVP measurement, then this skill is worth being passed to physicians in training. Previously&#xD;
      it was not possible gather enough information about the response of patients' because of the&#xD;
      risk of using indwelling CVP sensors. But now because there is a low risk tool (Venus 1000&#xD;
      System), this study is now practical and safe.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">April 2016</completion_date>
  <primary_completion_date type="Anticipated">March 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The correspondence of resuscitation decision and CVP value</measure>
    <time_frame>At patient admission to ED</time_frame>
    <description>The non-invasive CVP will be measured at the time of initial ordering decision by the ED physician. Afterwards, its relationship to the decision about whether to start intravenous fluid resuscitation will be analyzed.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Hypotension</condition>
  <arm_group>
    <arm_group_label>Patients brought to Hahnemann Hospital ED</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mespere Venus 1000 CVP System</intervention_name>
    <arm_group_label>Patients brought to Hahnemann Hospital ED</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients brough to Hahnemann Hospital ED&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients &gt;=18 years of age who enter the Emergency Department at Hahnemann&#xD;
             Hospital with Systolic Blood pressure &lt; 100 mm Hg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those patients who are suffering from traumatic injury requiring Level I or Level II&#xD;
             trauma evaluations. Example conditions include penetrating injuries to head, torso and&#xD;
             proximal extremities.&#xD;
&#xD;
          -  Additional exclusion criteria include the presence of an internal jugular or a&#xD;
             subclavian central venous line or both external jugular veins being cannulated&#xD;
             (attempted or successful) with peripheral IVs.&#xD;
&#xD;
          -  Pregnant females will be excluded.&#xD;
&#xD;
          -  Subjects under the age of 18 years will be excluded&#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>Neal Handly, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Drexel University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hahnemann Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</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>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 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>
  <keyword>Systolic Blood pressure &lt; 100 mm Hg</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</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/NCT02221908
org study id: IRB1401002513
nct id: NCT02221908
lead sponsor: 
has dmc: No
The goal of this study is to assess decision making skills of emergency physicians when
      dealing with hypotensive patients. The hypothesis is that decisions made based on physical
      exam and vital signs regarding fluid resuscitation by emergency physicians are not
      statistically equivalent to those that would be made based on the use of a non-invasive CVP
      measurement
If physicians can make appropriate decisions about the need for fluid resuscitation without
      CVP measurement, then this skill is worth being passed to physicians in training. Previously
      it was not possible gather enough information about the response of patients' because of the
      risk of using indwelling CVP sensors. But now because there is a low risk tool (Venus 1000
      System), this study is now practical and safe.
observational model: Cohort
time perspective: Prospective
measure: The correspondence of resuscitation decision and CVP value
time frame: At patient admission to ED
description: The non-invasive CVP will be measured at the time of initial ordering decision by the ED physician. Afterwards, its relationship to the decision about whether to start intravenous fluid resuscitation will be analyzed.
arm group label: Patients brought to Hahnemann Hospital ED
intervention type: Device
intervention name: Mespere Venus 1000 CVP System
arm group label: Patients brought to Hahnemann Hospital ED
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neal Handly, MD
role: Principal Investigator
affiliation: Drexel University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypotension