<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/NCT04425161</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU MD 1322018</org_study_id>
    <nct_id>NCT04425161</nct_id>
  </id_info>
  <brief_title>Ratio of ''Central Venous-to-Arterial Co2 Gap'' to ''Arterial-to-Central Venous O2 Content Gap'' in Septic Shock</brief_title>
  <official_title>Role of &quot;Central Venous-to-Arterial Carbon Dioxide&quot; to &quot;Arterial-to-Central Venous Oxygen Content&quot; Ratio, as a Marker of Anaerobic Metabolism in Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</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 high ratio of &quot;central venous to arterial carbon dioxide&quot; to &quot;arterial to central venous&#xD;
      oxygen content &quot; is associated with elevated lactate in patients with septic shock.&#xD;
&#xD;
      So, the aim of the present study is to evaluate the ratio of &quot;central venous-to-arterial CO2&#xD;
      tension or content&quot; to &quot;arterial-to-venous O2 content'' as an indicator of anaerobic&#xD;
      metabolism in septic shock.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective single center observational study that will be conducted in adult&#xD;
      intensive care unit of Ain Shams University After being approved by local institutional ethic&#xD;
      committee (Ain Shams University, Egypt). Informed consent was obtained from each&#xD;
      participant's next of kin. The investigator will study mechanically ventilated participants.&#xD;
      the attending physician's decision is to give IV fluids to participants due to the presence&#xD;
      of at least one clinical sign of inadequate tissue perfusion due to septic shock : (a)&#xD;
      systolic arterial pressure &lt;90 mmHg, mean arterial pressure &lt;65 mmHg, or the need for&#xD;
      vasopressor infusion; (b) skin mottling; (c) lactate level &gt;2 mmo/L; or (d) urinary output&#xD;
      &lt;0.5 mL/kg/h for ≥2 h. Jugular central venous and arterial catheters will be in place by the&#xD;
      attending physician. Investigator will confirm the position of the tip of the central venous&#xD;
      catheter in the superior vena cava or upper part of the right atrium on chest radiograph.&#xD;
      Participants will be monitored by Flo Trac device as a part of routine management in local&#xD;
      ICU.&#xD;
&#xD;
      A first set of measurements will be performed, including hemodynamic and tissue oxygenation&#xD;
      variables (heart rate, mean arterial pressure, cardiac index (CI), oxygen delivery (DO2),&#xD;
      oxygen consumption (VO2), Central venous oxygen saturation (ScvO2), arterial lactic acid&#xD;
      level, central venous to arterial carbon dioxide tension difference (∆PCO2), central venous&#xD;
      to arterial CO2 content difference (∆ContCO2), arterial-to-central venous oxygen content&#xD;
      difference (∆ContO2), ∆ContCO2/∆ContO2 ratio and ∆PCO2/∆ContO2 ratio. 500 ml of isotonic&#xD;
      saline 0.9% will be infused to the participants via a specific venous line over 15 minutes.&#xD;
      Immediately after volume expansion, a second set of the previous measurements will be&#xD;
      recorded. Ventilation parameters, Norepinephrine dose and sedation drugs will be kept&#xD;
      constant during the fluid challenge.&#xD;
&#xD;
      After fluid challenge, Participants with an increase in cardiac index ≥15% will be defined as&#xD;
      fluid responders. Fluid responders will be divided into 2 groups based on increase in oxygen&#xD;
      consumption (VO2) ( &lt; or ≥15%).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Evaluation of the change of the ratio of &quot;central venous-to-arterial CO2 tension or content&quot; to &quot;arterial-to-central venous O2 content&quot; as an effective marker to indicate anaerobic metabolism in septic shock.</measure>
    <time_frame>Measurements will be taken immediately before and immediately after volume expansion</time_frame>
    <description>To evaluate the change of the ratio of &quot;central venous-to-arterial CO2 tension or content&quot; to &quot;arterial-to-central venous O2 content&quot; between immediately before and Immedialey after volume expansion to indicate anaerobic metabolism in septic shock.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>VO2 ≥15 %</arm_group_label>
    <description>This group is classified based on increased oxygen consumption (VO2) ≥15 % by volume expansion in fluid responders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VO2 &lt;15 %</arm_group_label>
    <description>This group is classified based on increased oxygen consumption (VO2) &lt; 15 % by volume expansion in fluid responders</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fluid challenge (0.9 % NaCl)</intervention_name>
    <description>500 ml Fluid challenge of (0.9 % NaCl) will be given</description>
    <arm_group_label>VO2 &lt;15 %</arm_group_label>
    <arm_group_label>VO2 ≥15 %</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients who will be admitted to intensive care units and eligible for the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;18 years.&#xD;
&#xD;
          2. Suspected infection focus&#xD;
&#xD;
          3. Mean blood pressure &lt;65 mmHg, or required vasopressor infusion.&#xD;
&#xD;
          4. Lactic acid level &gt;2 mmol/l.&#xD;
&#xD;
          5. Mechanically ventilated patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age equal or less than 18 years.&#xD;
&#xD;
          2. Pregnant women.&#xD;
&#xD;
          3. Liver cirrhosis Child-Pugh C.&#xD;
&#xD;
          4. Chronic obstructive pulmonary disease.&#xD;
&#xD;
          5. Previous episode of septic shock within the last 3 months.&#xD;
&#xD;
          6. Patients with a contraindication to volume expansion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed A Elsawy, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ayman M Kamaly, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AinShams</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 20, 2021</last_update_submitted>
  <last_update_submitted_qc>August 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ahmed Atta Ahmed Elsawy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sepsis</keyword>
  <keyword>PCO2 gap</keyword>
  <keyword>PCO2 gap/ O2 content gap</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/NCT04425161
org study id: FMASU MD 1322018
nct id: NCT04425161
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The high ratio of "central venous to arterial carbon dioxide" to "arterial to central venous
      oxygen content " is associated with elevated lactate in patients with septic shock.

      So, the aim of the present study is to evaluate the ratio of "central venous-to-arterial CO2
      tension or content" to "arterial-to-venous O2 content'' as an indicator of anaerobic
      metabolism in septic shock.
This is a prospective single center observational study that will be conducted in adult
      intensive care unit of Ain Shams University After being approved by local institutional ethic
      committee (Ain Shams University, Egypt). Informed consent was obtained from each
      participant's next of kin. The investigator will study mechanically ventilated participants.
      the attending physician's decision is to give IV fluids to participants due to the presence
      of at least one clinical sign of inadequate tissue perfusion due to septic shock : (a)
      systolic arterial pressure <90 mmHg, mean arterial pressure <65 mmHg, or the need for
      vasopressor infusion; (b) skin mottling; (c) lactate level >2 mmo/L; or (d) urinary output
      <0.5 mL/kg/h for ≥2 h. Jugular central venous and arterial catheters will be in place by the
      attending physician. Investigator will confirm the position of the tip of the central venous
      catheter in the superior vena cava or upper part of the right atrium on chest radiograph.
      Participants will be monitored by Flo Trac device as a part of routine management in local
      ICU.

      A first set of measurements will be performed, including hemodynamic and tissue oxygenation
      variables (heart rate, mean arterial pressure, cardiac index (CI), oxygen delivery (DO2),
      oxygen consumption (VO2), Central venous oxygen saturation (ScvO2), arterial lactic acid
      level, central venous to arterial carbon dioxide tension difference (∆PCO2), central venous
      to arterial CO2 content difference (∆ContCO2), arterial-to-central venous oxygen content
      difference (∆ContO2), ∆ContCO2/∆ContO2 ratio and ∆PCO2/∆ContO2 ratio. 500 ml of isotonic
      saline 0.9% will be infused to the participants via a specific venous line over 15 minutes.
      Immediately after volume expansion, a second set of the previous measurements will be
      recorded. Ventilation parameters, Norepinephrine dose and sedation drugs will be kept
      constant during the fluid challenge.

      After fluid challenge, Participants with an increase in cardiac index ≥15% will be defined as
      fluid responders. Fluid responders will be divided into 2 groups based on increase in oxygen
      consumption (VO2) ( < or ≥15%).
observational model: Cohort
time perspective: Prospective
measure: Evaluation of the change of the ratio of "central venous-to-arterial CO2 tension or content" to "arterial-to-central venous O2 content" as an effective marker to indicate anaerobic metabolism in septic shock.
time frame: Measurements will be taken immediately before and immediately after volume expansion
description: To evaluate the change of the ratio of "central venous-to-arterial CO2 tension or content" to "arterial-to-central venous O2 content" between immediately before and Immedialey after volume expansion to indicate anaerobic metabolism in septic shock.
arm group label: VO2 ≥15 %
description: This group is classified based on increased oxygen consumption (VO2) ≥15 % by volume expansion in fluid responders
arm group label: VO2 <15 %
description: This group is classified based on increased oxygen consumption (VO2) < 15 % by volume expansion in fluid responders
intervention type: Other
intervention name: Fluid challenge (0.9 % NaCl)
description: 500 ml Fluid challenge of (0.9 % NaCl) will be given
arm group label: VO2 <15 %
arm group label: VO2 ≥15 %
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed A Elsawy, Master
role: Principal Investigator
affiliation: Ain Shams University
last name: Ayman M Kamaly, Professor
role: Study Director
affiliation: Ain Shams University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ahmed Atta Ahmed Elsawy
investigator title: Principal Investigator
mesh term: Shock, Septic
mesh term: Shock