xml: <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/NCT05984407</url>
    </required_header>
    <id_info>
      <org_study_id>652779</org_study_id>
      <nct_id>NCT05984407</nct_id>
    </id_info>
    <brief_title>EFFECTS OF EXTRACORPOREAL CYTOKINE ELIMINATION ON HEMODYNAMIA AND MORTALITY IN CRITICAL PATIENTS</brief_title>
    <official_title>EFFECTS OF EXTRACORPOREAL CYTOKINE ELIMINATION ON HEMODYNAMIA AND MORTALITY IN CRITICAL PATIENTS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hakan Küçükkepeci</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and&#xD;
        mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation&#xD;
        without microbiological findings in the intensive care unit.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and&#xD;
        mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation&#xD;
        without microbiological findings and met the inclusion criteria in the Intensive Care Unit&#xD;
        between 01.08.2023 and 01.02.2024&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The time to resolution of vasoplegic shock within days.</measure>
      <time_frame>From enrollment to the end of treatment at 12 weeks</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>7-day mortality</measure>
      <time_frame>7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mortality until discharge from hospital</measure>
      <time_frame>From enrollment to the end of treatment at 12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin 1 beta level on day 1</measure>
      <time_frame>one day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin 10 level on day 1</measure>
      <time_frame>one day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin 6 level on day 1</measure>
      <time_frame>one day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TNF - α level on day 1</measure>
      <time_frame>one day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin 1 beta level on day 3</measure>
      <time_frame>3 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin 10 level on day 3</measure>
      <time_frame>3 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin 6 level on day 3</measure>
      <time_frame>3 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TNF - α level on day 3</measure>
      <time_frame>3 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mechanical ventilation need and duration</measure>
      <time_frame>From enrollment to the end of treatment at 12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>duration of treatment in the intensive care unit</measure>
      <time_frame>From enrollment to the end of treatment at 12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>dose of catecholamine</measure>
      <time_frame>From enrollment to the end of treatment at 12 weeks</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Cytokine Hemadsorption Therapy in Critically Ill Patients Who Have no Microbiological Findings and Develop Vasoplegic Shock</condition>
    <arm_group>
      <arm_group_label>patients with vasoplegic shock</arm_group_label>
      <description>Application of cytokine hemadsorption therapy in patients with vasoplegic shock without microbiological findings</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>cytokine hemadsorption therapy</intervention_name>
      <description>Observation of cytokine hemadsorption therapy in critically ill patients who have no microbiological findings and develop vasoplegic shock.</description>
      <arm_group_label>patients with vasoplegic shock</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Thirty patients who met the inclusion criteria were included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  C-reactive protein (CRP) ≥ 100 mg/l&#xD;
  &#xD;
            -  Procalcitonin (PCT) &lt; 2 ng/l&#xD;
  &#xD;
            -  Patients aged 18-80 years who were treated with cytokine adsorption due to vasoplegic&#xD;
               shock&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients under 18 years of age&#xD;
  &#xD;
            -  Patients with suspected or proven bacterial cause of vasoplegic shock.&#xD;
  &#xD;
            -  Those who did not approve to participate in the study&#xD;
  &#xD;
            -  Patients without vasoplegic shock&#xD;
  &#xD;
            -  Patients with CRP &lt; 100 mg/l, PCT ≥ 2 μg/L&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Prof. Dr. Cemil Taşcıoğlu City Hospital</name>
        <address>
          <city>İstanbul</city>
          <state>Şişli</state>
          <zip>34384</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</investigator_affiliation>
      <investigator_full_name>Hakan Küçükkepeci</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>vasoplegic shock, cytokine hemadsorption, hemodynamics, mortality, cytokine storm</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984407
  org study id: 652779
  nct id: NCT05984407
  lead sponsor: 
  has dmc: No
  Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and
        mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation
        without microbiological findings in the intensive care unit.
  Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and
        mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation
        without microbiological findings and met the inclusion criteria in the Intensive Care Unit
        between 01.08.2023 and 01.02.2024
  observational model: Case-Control
  time perspective: Prospective
  measure: The time to resolution of vasoplegic shock within days.
  time frame: From enrollment to the end of treatment at 12 weeks
  measure: 7-day mortality
  time frame: 7 days
  measure: mortality until discharge from hospital
  time frame: From enrollment to the end of treatment at 12 weeks
  measure: Interleukin 1 beta level on day 1
  time frame: one day
  measure: Interleukin 10 level on day 1
  time frame: one day
  measure: Interleukin 6 level on day 1
  time frame: one day
  measure: TNF - α level on day 1
  time frame: one day
  measure: Interleukin 1 beta level on day 3
  time frame: 3 days
  measure: Interleukin 10 level on day 3
  time frame: 3 days
  measure: Interleukin 6 level on day 3
  time frame: 3 days
  measure: TNF - α level on day 3
  time frame: 3 days
  measure: mechanical ventilation need and duration
  time frame: From enrollment to the end of treatment at 12 weeks
  measure: duration of treatment in the intensive care unit
  time frame: From enrollment to the end of treatment at 12 weeks
  measure: dose of catecholamine
  time frame: From enrollment to the end of treatment at 12 weeks
  arm group label: patients with vasoplegic shock
  description: Application of cytokine hemadsorption therapy in patients with vasoplegic shock without microbiological findings
  intervention type: Procedure
  intervention name: cytokine hemadsorption therapy
  description: Observation of cytokine hemadsorption therapy in critically ill patients who have no microbiological findings and develop vasoplegic shock.
  arm group label: patients with vasoplegic shock
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
  investigator full name: Hakan Küçükkepeci
  investigator title: Principal Investigator
  mesh term: Critical Illness