<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/NCT02195830</url>
  </required_header>
  <id_info>
    <org_study_id>AE14/11038</org_study_id>
    <secondary_id>14/NE/0023</secondary_id>
    <nct_id>NCT02195830</nct_id>
  </id_info>
  <brief_title>Inferior Vena Cava Collapsibility Index in Severe Sepsis</brief_title>
  <official_title>Bedside Ultrasound of Inferior Vena Cava Collapsibility in Emergency Department Patients Presenting With Severe Sepsis and Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teesside University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Teesside University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid&#xD;
      volume status in patients with sepsis.&#xD;
&#xD;
      To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we&#xD;
      first need to define the inferior vena cava collapsibility index in this population of&#xD;
      patients.&#xD;
&#xD;
      The research question is: In adult patients with sepsis, severe sepsis and septic shock what&#xD;
      is the mean baseline inferior vena cava collapsibility index (IVCCI) prior to fluid&#xD;
      resuscitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is an interventional cohort study using a convenience sample of adult patients in a&#xD;
      university teaching hospital Emergency Department.&#xD;
&#xD;
      Eligible participants who consent to partake in the trial will have an ultrasound assessment&#xD;
      of their inferior vena cava performed and the IVCCI will be calculated at enrolment.&#xD;
&#xD;
      Care will be provided in line with the published guidelines on sepsis management from the&#xD;
      Surviving Sepsis Campaign and the College of Emergency Medicine.&#xD;
&#xD;
      A sample size calculation has been performed which indicates that 112 patient with severe&#xD;
      sepsis or septic shock will need to be enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Mean baseline inferior vena cava collapsibility index</measure>
    <time_frame>At enrollment</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Sepsis</condition>
  <condition>Severe Sepsis</condition>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Single arm - Ultrasound</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All participants will have an Ultrasound measurement of their inferior vena cava at enrolment as described in the intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound of the inferior vena cava</intervention_name>
    <description>B mode ultrasound of the inferior vena cava Measurements taken 2cm from the hepatic vein IVC junction or 3cm from the right atrium IVC junction</description>
    <arm_group_label>Single arm - Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients&#xD;
&#xD;
          -  signs and symptoms of infection with 2 or more SIRS criteria (pulse rate &gt;90/min, Temp&#xD;
             &gt; 38 Celsius &lt; 36 Celsius, Respiratory rate &gt; 20 breaths per minute, or white cell&#xD;
             count &gt;12 or &lt;4 x 10^9/L)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  in relation to this episode of care: Prior cardio pulmonary resuscitation, acute&#xD;
             myocardial infarction, trauma, pregnancy or patient requiring immediate surgery.&#xD;
&#xD;
          -  Patients who have received more than 20ml/Kg of IV fluid in the pre hospital&#xD;
             environment&#xD;
&#xD;
          -  Patients with known tricuspid regurgitation, congestive heart failure or pulmonary&#xD;
             hypertension&#xD;
&#xD;
          -  Patients receiving palliative terminal supportive care&#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>Simon Richards, MHSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Teesside University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Simon Richards, MHSc</last_name>
    <email>s.richards@tees.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>St James's University Hospital</name>
      <address>
        <city>Leeds</city>
        <state>West yorkshire</state>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Stuart M Nuttall, FCEM</last_name>
      <email>stuart.nuttall@leedsth.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Stuart M Nuttall, FCEM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Teesside University</investigator_affiliation>
    <investigator_full_name>Simon Richards</investigator_full_name>
    <investigator_title>Programme Leader Medical Ultrasound</investigator_title>
  </responsible_party>
  <keyword>Sepsis</keyword>
  <keyword>ultrasound</keyword>
  <keyword>inferior vena cava collapsibility</keyword>
  <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>
  </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/NCT02195830
org study id: AE14/11038
secondary id: 14/NE/0023
nct id: NCT02195830
lead sponsor: 
has dmc: No
There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid
      volume status in patients with sepsis.

      To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we
      first need to define the inferior vena cava collapsibility index in this population of
      patients.

      The research question is: In adult patients with sepsis, severe sepsis and septic shock what
      is the mean baseline inferior vena cava collapsibility index (IVCCI) prior to fluid
      resuscitation.
The study is an interventional cohort study using a convenience sample of adult patients in a
      university teaching hospital Emergency Department.

      Eligible participants who consent to partake in the trial will have an ultrasound assessment
      of their inferior vena cava performed and the IVCCI will be calculated at enrolment.

      Care will be provided in line with the published guidelines on sepsis management from the
      Surviving Sepsis Campaign and the College of Emergency Medicine.

      A sample size calculation has been performed which indicates that 112 patient with severe
      sepsis or septic shock will need to be enrolled.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Mean baseline inferior vena cava collapsibility index
time frame: At enrollment
arm group label: Single arm - Ultrasound
arm group type: Other
description: All participants will have an Ultrasound measurement of their inferior vena cava at enrolment as described in the intervention
intervention type: Other
intervention name: Ultrasound of the inferior vena cava
description: B mode ultrasound of the inferior vena cava Measurements taken 2cm from the hepatic vein IVC junction or 3cm from the right atrium IVC junction
arm group label: Single arm - Ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Richards, MHSc
role: Principal Investigator
affiliation: Teesside University
last name: Simon Richards, MHSc
email: s.richards@tees.ac.uk
facility: 
contact: 
investigator: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Teesside University
investigator full name: Simon Richards
investigator title: Programme Leader Medical Ultrasound
mesh term: Sepsis
mesh term: Toxemia
mesh term: Shock, Septic