<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/NCT01668329</url>
  </required_header>
  <id_info>
    <org_study_id>2009-A00822-55</org_study_id>
    <nct_id>NCT01668329</nct_id>
  </id_info>
  <brief_title>Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)</brief_title>
  <acronym>BIOSEPSIS</acronym>
  <official_title>Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Septic shock is a frequent pathology responsible for over 30000 deaths/year in France. Its&#xD;
      outcome has not been improved despite the knowledge on inflammatory processes; a reason for&#xD;
      these lack of results may lay on the lack of data on the precise dynamics of inflammatory and&#xD;
      anti-inflammatory cascades and their consequences. We intend to achieve accurate monitoring&#xD;
      of the inflammatory process on a small group of non-immunocompromised patients. Our goal is&#xD;
      to obtain quality data, repeated over time, by limiting the technical variability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim is to obtain precise data on the dynamics of cytokines, oxydative stress and hormonal&#xD;
      response on immunocompetent adults during septic shock.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Evolutive profile of the inflammatory response during septic shock</measure>
    <time_frame>Hospitalisation in ICU</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Research for early prognosis factors</measure>
    <time_frame>Hospitalisation in ICU</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">64</enrollment>
  <condition>Immunocompetent Patient on Septic Shock</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      hormons, inflammatory markers, vitamines recovered from the patients serum.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All immunocompetent patients hospitalised in intensive care from the beginning of the&#xD;
        septic shock state.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years admitted in ICU.&#xD;
&#xD;
          -  Clinical evidence of infection, suspected or proved, during the 48hrs following the&#xD;
             hospital entry.&#xD;
&#xD;
          -  Systemic inflammatory response syndrome.&#xD;
&#xD;
          -  Shock defined as arterial hypotension (&lt;90mmHg)not responding to adequated filling.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minors&#xD;
&#xD;
          -  Patient under guardianship or trusteeship&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Not affiliated to the social security&#xD;
&#xD;
          -  Deprived of liberty by court decision&#xD;
&#xD;
          -  Patients hospitalised without their approval&#xD;
&#xD;
          -  Shock related to another cause than infection&#xD;
&#xD;
          -  Long term corticothérapy&#xD;
&#xD;
          -  On-going chemiothérapy, AIDS&#xD;
&#xD;
          -  Bedridden patient&#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>TIMSIT Jean FRANCOIS, PU/PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 8, 2010</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>January 16, 2015</last_update_submitted>
  <last_update_submitted_qc>January 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Grenoble</investigator_affiliation>
    <investigator_full_name>AdministrateurDRC</investigator_full_name>
    <investigator_title>Pr JF TIMSIT</investigator_title>
  </responsible_party>
  <keyword>Septic shock</keyword>
  <keyword>Inflammatory process</keyword>
  <keyword>Cytokines</keyword>
  <keyword>Hormonal response</keyword>
  <keyword>Oxydative stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Shock</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/NCT01668329
org study id: 2009-A00822-55
nct id: NCT01668329
lead sponsor: 
has dmc: Yes
Septic shock is a frequent pathology responsible for over 30000 deaths/year in France. Its
      outcome has not been improved despite the knowledge on inflammatory processes; a reason for
      these lack of results may lay on the lack of data on the precise dynamics of inflammatory and
      anti-inflammatory cascades and their consequences. We intend to achieve accurate monitoring
      of the inflammatory process on a small group of non-immunocompromised patients. Our goal is
      to obtain quality data, repeated over time, by limiting the technical variability.
The aim is to obtain precise data on the dynamics of cytokines, oxydative stress and hormonal
      response on immunocompetent adults during septic shock.
observational model: Cohort
time perspective: Prospective
measure: Evolutive profile of the inflammatory response during septic shock
time frame: Hospitalisation in ICU
measure: Research for early prognosis factors
time frame: Hospitalisation in ICU
hormons, inflammatory markers, vitamines recovered from the patients serum.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: TIMSIT Jean FRANCOIS, PU/PH
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Grenoble
investigator full name: AdministrateurDRC
investigator title: Pr JF TIMSIT
mesh term: Shock, Septic
mesh term: Shock