<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/NCT02232750</url>
  </required_header>
  <id_info>
    <org_study_id>20141524</org_study_id>
    <nct_id>NCT02232750</nct_id>
  </id_info>
  <brief_title>Evaluation of CPD MNV as an Aid in the Diagnosis and Risk Assessment of Sepsis (Protocol # Sepsis 1-14)</brief_title>
  <acronym>Beckman</acronym>
  <official_title>Evaluation of CPD (Cell Population Data) MNV (Mean Neutrophil Volume) as an Aid in the Diagnosis and Risk Assessment of Sepsis (Protocol # Sepsis 1-14)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that CPD parameters will provide improved prediction of sepsis&#xD;
      compared to currently employed laboratory parameters. These studies hold the potential to&#xD;
      shape practitioner guidelines and improve the timeliness and accuracy with which patients&#xD;
      with sepsis are treated today.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2014</start_date>
  <completion_date type="Actual">August 15, 2015</completion_date>
  <primary_completion_date type="Actual">August 15, 2015</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>We are measuring CBC (complete blood count) and MNV (Mean Neutrophil Volume)</measure>
    <time_frame>approximately 10 months</time_frame>
    <description>Evaluate the clinical utility of CPD MNV as an aid in the diagnosis and risk assessment of Emergency Department patients for progression to sepsis, severe sepsis and septic shock.</description>
  </primary_outcome>
  <enrollment type="Actual">1320</enrollment>
  <condition>Sepsis, Severe Sepsis and Septic Shock</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Emergency Department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (≥18 to 90 years)&#xD;
&#xD;
          -  Patients presenting to the Emergency Department&#xD;
&#xD;
          -  CBC (Complete Blood Count) with differential testing performed and CPD data retrieved&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously enrolled in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Wexner Medical Center at The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>November 1, 2021</last_update_submitted>
  <last_update_submitted_qc>November 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Elliott Crouser MD</investigator_full_name>
    <investigator_title>Medical Director, Intensive Care Unit</investigator_title>
  </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>
  <!-- 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/NCT02232750
org study id: 20141524
nct id: NCT02232750
lead sponsor: 
has dmc: Yes
The investigators hypothesize that CPD parameters will provide improved prediction of sepsis
      compared to currently employed laboratory parameters. These studies hold the potential to
      shape practitioner guidelines and improve the timeliness and accuracy with which patients
      with sepsis are treated today.
observational model: Cohort
time perspective: Prospective
measure: We are measuring CBC (complete blood count) and MNV (Mean Neutrophil Volume)
time frame: approximately 10 months
description: Evaluate the clinical utility of CPD MNV as an aid in the diagnosis and risk assessment of Emergency Department patients for progression to sepsis, severe sepsis and septic shock.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Elliott Crouser MD
investigator title: Medical Director, Intensive Care Unit
mesh term: Sepsis
mesh term: Toxemia