<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/NCT03292120</url>
  </required_header>
  <id_info>
    <org_study_id>2016-07</org_study_id>
    <secondary_id>2016-A00586-45</secondary_id>
    <nct_id>NCT03292120</nct_id>
  </id_info>
  <brief_title>Venous to Arterial Carbon Dioxide Difference (P₍ᵥ-ₐ₎CO₂): Predictor of Septic Patient Prognosis Depending on the ScvO₂</brief_title>
  <official_title>Venous to Arterial Carbon Dioxide Difference (P₍ᵥ-ₐ₎CO₂): Predictor of Septic Patient Prognosis Depending on the ScvO₂</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      the investigators will include 120 patients with a diagnosis of septic shock in accordance&#xD;
      with the definition given by the 2001 expert consensus. Two groups of patients are likely to&#xD;
      participate in this study: Patient hospitalized in intensive care for a septic shock =&#xD;
      Primary patient + patient who develops, the waning of his hospitalization in intensive care&#xD;
      for another reason, a septic shock = Secondary patient. Haemodynamic monitoring by&#xD;
      transpulmonary thermodilution allow a patient's close monitoring during the initial phase&#xD;
      supported. The clinical and biological data, demographic and the severity scores are&#xD;
      collected for each patient during the first three days of stay. To predict the unfavorable&#xD;
      evolution of the patients, a measure of the SOFA score at the input (J0) and third day (J2)&#xD;
      is performed. the investigators analyzed mortality at day 28 in patients with increased&#xD;
      P₍ᵥ-ₐ₎CO₂ and those with increasing of organ failure. This research will be conducted&#xD;
      according to good clinical practice. An information will be distributed to patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">November 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>measure of the SOFA score</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>patients with septic shock</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>measure of the SOFA score</intervention_name>
    <description>The Sequential Organ Failure Assessment (SOFA) Score predicts ICU mortality based on lab results and clinical data.</description>
    <arm_group_label>patients with septic shock</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a diagnosis of septic shock&#xD;
&#xD;
          -  Initial lactate in patients should be≥ 2 mmol / L.&#xD;
&#xD;
          -  The presence of circulatory insufficiency defined by a systolic blood pressure ≤ 90&#xD;
             mmHg (or a drop in blood pressure≥ 50 mmHg in hypertensive patients)&#xD;
&#xD;
          -  One or more of the following: oliguria defined as diuresis≤ 0,5 mL/ kg / h for at&#xD;
             least two hours; the presence of signs of cerebral hypoperfusion; the highlighting of&#xD;
             mottling&#xD;
&#xD;
          -  The presence of a femoral arterial catheter and a central venous line in the superior&#xD;
             vena cava position&#xD;
&#xD;
          -  Hemodynamic monitoring with semi-invasive monitoring of cardiac output with&#xD;
             thermodilution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient no longer in the initial phase of septic shock&#xD;
&#xD;
          -  Absence of semi-invasive cardiac monitoring with thermodilution&#xD;
&#xD;
          -  Vulnerable people&#xD;
&#xD;
          -  Absence of informed consent&#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>jean olivier ARNAUD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assisitance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>May 7, 2019</last_update_submitted>
  <last_update_submitted_qc>May 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2019</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>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/NCT03292120
org study id: 2016-07
secondary id: 2016-A00586-45
nct id: NCT03292120
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the investigators will include 120 patients with a diagnosis of septic shock in accordance
      with the definition given by the 2001 expert consensus. Two groups of patients are likely to
      participate in this study: Patient hospitalized in intensive care for a septic shock =
      Primary patient + patient who develops, the waning of his hospitalization in intensive care
      for another reason, a septic shock = Secondary patient. Haemodynamic monitoring by
      transpulmonary thermodilution allow a patient's close monitoring during the initial phase
      supported. The clinical and biological data, demographic and the severity scores are
      collected for each patient during the first three days of stay. To predict the unfavorable
      evolution of the patients, a measure of the SOFA score at the input (J0) and third day (J2)
      is performed. the investigators analyzed mortality at day 28 in patients with increased
      P₍ᵥ-ₐ₎CO₂ and those with increasing of organ failure. This research will be conducted
      according to good clinical practice. An information will be distributed to patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: measure of the SOFA score
time frame: 28 days
arm group label: patients with septic shock
arm group type: Experimental
intervention type: Other
intervention name: measure of the SOFA score
description: The Sequential Organ Failure Assessment (SOFA) Score predicts ICU mortality based on lab results and clinical data.
arm group label: patients with septic shock
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: jean olivier ARNAUD
role: Study Director
affiliation: Assistance Publique Hopitaux De Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: Shock, Septic