<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/NCT02972827</url>
  </required_header>
  <id_info>
    <org_study_id>15-21</org_study_id>
    <nct_id>NCT02972827</nct_id>
  </id_info>
  <brief_title>Monitoring Devices in Prediction of Fluid Responsiveness in Severe Sepsis and Septic Shock</brief_title>
  <official_title>Comparison of the Accuracy of Monitoring Devices in Prediction of Fluid Responsiveness in Severe Sepsis and Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Santa Barbara Cottage Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Santa Barbara Cottage Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of noninvasive cardiac output monitor (NICOM, Cheetah Medical) with Edwards&#xD;
      FloTrac minimally-invasive cardiac output monitor in predicting fluid responsiveness in&#xD;
      sepsis and septic shock.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study will evaluate ability of passive leg raise test to predict fluid responsiveness in&#xD;
      patients in septic shock, on vasopressors, using both the NICOM and FloTrac devices. An&#xD;
      increase in CI, SVI, or Pulse Pressure of &gt;10% in response to the passive leg raise will be&#xD;
      considered a positive passive leg raise test, and the same indicators will be considered a&#xD;
      significant response to a fluid challenge with either crystalloids or colloids.Each device&#xD;
      will be evaluated independently, but simultaneously.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants who have agreement or disagreement between passive leg raise response and subsequent intravenous fluid challenge</measure>
    <time_frame>15 minutes</time_frame>
    <description>Positive passive leg raise response is defined as a 10% or greater increase in any of: stroke volume index, cardiac index, or pulse pressure following passive leg raise of 45 degrees for 3 minutes.&#xD;
Positive response to fluid challenge is defined as a 10% or greater increase in any of the same parameters following a 500ml or 1000 ml fluid challenge given over 10-15 minutes, using the same instrument, (NICOM or FloTrac). A negative response would be &lt; 10% increase in these parameters using the same instrument</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decrease in vasopressor dose, in response to fluid therapy guided by passive leg raise response using NICOM or Flotrac devices</measure>
    <time_frame>48 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Severe Sepsis</condition>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>NICOM/FloTrac</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>500-1000ml Crystalloid fluid challenge (normal saline or plasmalyte) to be given for positive passive leg raise test by either device, and also will be given at baseline, regardless of baseline PLR response.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NICOM/FloTrac</intervention_name>
    <description>Use of noninvasive cardiac output and minimally invasive cardiac output monitors</description>
    <arm_group_label>NICOM/FloTrac</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Crystalloid Fluid Challenge</intervention_name>
    <description>500-1000ml Normal Saline or Plasmalyte intravenous fluid bolus will be given at baseline, and following a positive passive leg raise response as defined by a 10% or greater increase in any of: stroke volume index, cardiac index, or pulse pressure, as measured by the NICOM or FloTrac Monitors.</description>
    <arm_group_label>NICOM/FloTrac</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients with severe sepsis or septic shock, who have arterial catheter&#xD;
             placed with FloTrac monitor, with or without a central venous catheter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Declination of consent&#xD;
&#xD;
          -  Known allergy to adhesive&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Contraindication to raising legs or head to 45 degrees for 3 minute intervals&#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>Santa Barbara Cottage Hospital</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>October 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2021</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>Shock, Septic</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 29, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT02972827/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 29, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT02972827/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02972827
org study id: 15-21
nct id: NCT02972827
lead sponsor: 
has dmc: No
Comparison of noninvasive cardiac output monitor (NICOM, Cheetah Medical) with Edwards
      FloTrac minimally-invasive cardiac output monitor in predicting fluid responsiveness in
      sepsis and septic shock.
Study will evaluate ability of passive leg raise test to predict fluid responsiveness in
      patients in septic shock, on vasopressors, using both the NICOM and FloTrac devices. An
      increase in CI, SVI, or Pulse Pressure of >10% in response to the passive leg raise will be
      considered a positive passive leg raise test, and the same indicators will be considered a
      significant response to a fluid challenge with either crystalloids or colloids.Each device
      will be evaluated independently, but simultaneously.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of participants who have agreement or disagreement between passive leg raise response and subsequent intravenous fluid challenge
time frame: 15 minutes
description: Positive passive leg raise response is defined as a 10% or greater increase in any of: stroke volume index, cardiac index, or pulse pressure following passive leg raise of 45 degrees for 3 minutes.
Positive response to fluid challenge is defined as a 10% or greater increase in any of the same parameters following a 500ml or 1000 ml fluid challenge given over 10-15 minutes, using the same instrument, (NICOM or FloTrac). A negative response would be < 10% increase in these parameters using the same instrument
measure: Decrease in vasopressor dose, in response to fluid therapy guided by passive leg raise response using NICOM or Flotrac devices
time frame: 48 hours
arm group label: NICOM/FloTrac
arm group type: Experimental
description: 500-1000ml Crystalloid fluid challenge (normal saline or plasmalyte) to be given for positive passive leg raise test by either device, and also will be given at baseline, regardless of baseline PLR response.
intervention type: Device
intervention name: NICOM/FloTrac
description: Use of noninvasive cardiac output and minimally invasive cardiac output monitors
arm group label: NICOM/FloTrac
intervention type: Other
intervention name: Crystalloid Fluid Challenge
description: 500-1000ml Normal Saline or Plasmalyte intravenous fluid bolus will be given at baseline, and following a positive passive leg raise response as defined by a 10% or greater increase in any of: stroke volume index, cardiac index, or pulse pressure, as measured by the NICOM or FloTrac Monitors.
arm group label: NICOM/FloTrac
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Toxemia
mesh term: Shock, Septic
mesh term: Shock
sharing ipd: No
provided document: 
provided document: 