<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/NCT02185118</url>
  </required_header>
  <id_info>
    <org_study_id>NSFC-81171839</org_study_id>
    <secondary_id>Chinese NSFC</secondary_id>
    <nct_id>NCT02185118</nct_id>
  </id_info>
  <brief_title>Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Experimental Sepsis</brief_title>
  <official_title>In-vitro Experimental Study About Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Sepsis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sepsis is a major cause of death in intensive care units. Despite the investigators improved&#xD;
      understanding, which has reduced the risk of dying with sepsis, the number of people who die&#xD;
      each year continues to increase due to an overall increase in the number of cases.In our&#xD;
      previous study, the investigators have showed that 100% oxygen or 0.5 minimum alveolar&#xD;
      concentration (MAC) isoflurane/sevoflurane in 60% oxygen protect mouse macrophage cell line&#xD;
      against in-vitro sepsis induced by lipopolysaccharide (LPS).&#xD;
&#xD;
      In this study, the investigator hypothesized that treatment of 100% oxygen or 0.5 MAC&#xD;
      isoflurane/sevoflurane in 60% oxygen protected against clinical in-vitro models of sepsis&#xD;
      induced by LPS or plasma from septic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      100% oxygen or 0.5 MAC isoflurane/sevoflurane in 60% oxygen would inhibit increases of tumor&#xD;
      necrosis factor (TNF)-alpha, interleukin-1beta, interleukin-6 in the cell culture supernatant&#xD;
      after stimulation of LPS or plasma from septic patients, and also inhibit the nuclear&#xD;
      location of nuclear factor-kappa B p65 subunit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">June 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subcellular location of Nuclear Factor-KAPPA B p65 subunit</measure>
    <time_frame>within 10 hours after the intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>tumor necrosis factor-alpha</measure>
    <time_frame>within 10 hours after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin- 1 beta</measure>
    <time_frame>within 10 hours after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin 6</measure>
    <time_frame>within 10 hours after the intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>oxygen plus isoflurane/sevoflurane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All human peripheral blood mononuclear cells (PBMCs) were from patients with non sepsis/non SIRS/non infection.&#xD;
The above cells were treated with oxygen or oxygen plus isoflurane/sevoflurane after stimulation of lipopolysaccharide/plasma from septic patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oxygen</intervention_name>
    <description>Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.&#xD;
Treatment of 100% oxygen or subanesthetic sevoflurane in 60% oxygen or subanesthetic isoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients.</description>
    <arm_group_label>oxygen plus isoflurane/sevoflurane</arm_group_label>
    <other_name>100% oxygen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.&#xD;
Treatment of 100% oxygen or subanesthetic sevoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients.</description>
    <arm_group_label>oxygen plus isoflurane/sevoflurane</arm_group_label>
    <other_name>subanesthetic sevoflurane in 60% oxygen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isoflurane</intervention_name>
    <description>Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.&#xD;
Treatment of 100% oxygen or subanesthetic isoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients.</description>
    <arm_group_label>oxygen plus isoflurane/sevoflurane</arm_group_label>
    <other_name>subanesthetic isoflurane in 60% oxygen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Human PBMCs were only isolated from the adult patients without sepsis/SIRS/infectious&#xD;
             diseases.&#xD;
&#xD;
          -  The plasma for induction of clinical in-vitro sepsis, was only isolated from adult&#xD;
             patients with sepsis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had been selected for other clinical trials in the 3 months before.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lichao Hou, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Air Force Military Medical University, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lichao Hou, M.D., Ph.D.</last_name>
    <email>hou2001@fmmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Anesthesiology, Xijing Hospital, Fourth Military Medical University,</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>lichao Hou</last_name>
      <email>hou2001@fmmu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 6, 2014</last_update_submitted>
  <last_update_submitted_qc>July 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Lichao Hou</investigator_full_name>
    <investigator_title>M.D., Ph.D</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sevoflurane</mesh_term>
    <mesh_term>Isoflurane</mesh_term>
  </intervention_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/NCT02185118
org study id: NSFC-81171839
secondary id: Chinese NSFC
nct id: NCT02185118
lead sponsor: 
has dmc: No
Sepsis is a major cause of death in intensive care units. Despite the investigators improved
      understanding, which has reduced the risk of dying with sepsis, the number of people who die
      each year continues to increase due to an overall increase in the number of cases.In our
      previous study, the investigators have showed that 100% oxygen or 0.5 minimum alveolar
      concentration (MAC) isoflurane/sevoflurane in 60% oxygen protect mouse macrophage cell line
      against in-vitro sepsis induced by lipopolysaccharide (LPS).

      In this study, the investigator hypothesized that treatment of 100% oxygen or 0.5 MAC
      isoflurane/sevoflurane in 60% oxygen protected against clinical in-vitro models of sepsis
      induced by LPS or plasma from septic patients.
100% oxygen or 0.5 MAC isoflurane/sevoflurane in 60% oxygen would inhibit increases of tumor
      necrosis factor (TNF)-alpha, interleukin-1beta, interleukin-6 in the cell culture supernatant
      after stimulation of LPS or plasma from septic patients, and also inhibit the nuclear
      location of nuclear factor-kappa B p65 subunit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Subcellular location of Nuclear Factor-KAPPA B p65 subunit
time frame: within 10 hours after the intervention
measure: tumor necrosis factor-alpha
time frame: within 10 hours after the intervention
measure: interleukin- 1 beta
time frame: within 10 hours after the intervention
measure: interleukin 6
time frame: within 10 hours after the intervention
arm group label: oxygen plus isoflurane/sevoflurane
arm group type: Experimental
description: All human peripheral blood mononuclear cells (PBMCs) were from patients with non sepsis/non SIRS/non infection.
The above cells were treated with oxygen or oxygen plus isoflurane/sevoflurane after stimulation of lipopolysaccharide/plasma from septic patients.
intervention type: Drug
intervention name: oxygen
description: Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.
Treatment of 100% oxygen or subanesthetic sevoflurane in 60% oxygen or subanesthetic isoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients.
arm group label: oxygen plus isoflurane/sevoflurane
other name: 100% oxygen
intervention type: Drug
intervention name: Sevoflurane
description: Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.
Treatment of 100% oxygen or subanesthetic sevoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients.
arm group label: oxygen plus isoflurane/sevoflurane
other name: subanesthetic sevoflurane in 60% oxygen
intervention type: Drug
intervention name: Isoflurane
description: Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.
Treatment of 100% oxygen or subanesthetic isoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients.
arm group label: oxygen plus isoflurane/sevoflurane
other name: subanesthetic isoflurane in 60% oxygen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lichao Hou, M.D., Ph.D.
role: Principal Investigator
affiliation: Air Force Military Medical University, China
last name: Lichao Hou, M.D., Ph.D.
email: hou2001@fmmu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Lichao Hou
investigator title: M.D., Ph.D
mesh term: Sepsis
mesh term: Toxemia
mesh term: Sevoflurane
mesh term: Isoflurane