<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/NCT04448951</url>
  </required_header>
  <id_info>
    <org_study_id>IMHOTEP</org_study_id>
    <nct_id>NCT04448951</nct_id>
  </id_info>
  <brief_title>Immune Homeostasis in Sepsis and Septic Shock</brief_title>
  <acronym>IMHOTEP</acronym>
  <official_title>Immune Homeostasis in Patients With Sepsis and Septic Shock: a Single Center Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charles University, Czech Republic</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>
      Detailed description of immune response and its dynamics in sepsis and septic shock patiens&#xD;
      by means of transcriptomics, flow-cytometry and cytokine analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>90 Days</target_duration>
  <primary_outcome>
    <measure>Immune response description - flow cytometry</measure>
    <time_frame>2024 - 2026</time_frame>
    <description>Detailed description of immune response analyzed by mean of flow cytometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immune response description - transcriptomics</measure>
    <time_frame>2024 - 2026</time_frame>
    <description>Detailed description of immune response analyzed by mean of transcriptomic analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immune response description - ELISA</measure>
    <time_frame>2024 - 2026</time_frame>
    <description>Detailed description of immune response analyzed by mean of ELISA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic &quot;immune status&quot; panel</measure>
    <time_frame>2026 - 2028</time_frame>
    <description>Diagnostic tool for immune status assessment</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Sepsis</condition>
  <condition>Immunologic Paralysis</condition>
  <condition>Immunologic Suppression</condition>
  <condition>Immune Deficiency</condition>
  <arm_group>
    <arm_group_label>sepsis/septic shock</arm_group_label>
    <description>target population</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-septic critically ill</arm_group_label>
    <description>demographically-matched control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy control</arm_group_label>
    <description>control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>transcriptomics</intervention_name>
    <description>transcriptomics</description>
    <arm_group_label>healthy control</arm_group_label>
    <arm_group_label>non-septic critically ill</arm_group_label>
    <arm_group_label>sepsis/septic shock</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>flow-cytometry</intervention_name>
    <description>peripheral blood myeloid cells and lymphocytes flow-cytometry</description>
    <arm_group_label>healthy control</arm_group_label>
    <arm_group_label>non-septic critically ill</arm_group_label>
    <arm_group_label>sepsis/septic shock</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cytokines</intervention_name>
    <description>peripheral blood cytokine analysis</description>
    <arm_group_label>healthy control</arm_group_label>
    <arm_group_label>non-septic critically ill</arm_group_label>
    <arm_group_label>sepsis/septic shock</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      peripheral blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        sepsis/septic shock according SEPSIS-3 definition&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  sepsis/septic shock (SEPSIS-3)&#xD;
&#xD;
          -  age ≥18&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  inclusion within first 24hrs after development/diagnosis of septic shock&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  disagreement of the patient or legal representative with the entry into the study&#xD;
&#xD;
          -  patients with primary or secondary immunodeficiency&#xD;
&#xD;
          -  presence of active haematological malignancy or an active non-haematological&#xD;
             malignancy&#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>Thomas Karvunidis, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carles University Teaching Hospital and Faculty of Medicine in Pilsen, Pilsen, Czech Republic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Karvunidis, MD, Ph.D.</last_name>
    <phone>+420 377 103 173</phone>
    <email>karvunidist@fnplzen.cz</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marcela Královcová, MD</last_name>
    <phone>+420 377 103 173</phone>
    <email>kralovcovam@fnplzen.cz</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical ICU, 1st Dept. of Internal Medicine, Teaching Hospital in Pilsen</name>
      <address>
        <city>Pilsen</city>
        <state>Česká Republika</state>
        <zip>330 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Karvunidis, MD, Ph.D.</last_name>
      <phone>+420 377 103 173</phone>
      <email>karvunidist@fnplzen.cz</email>
    </contact>
    <contact_backup>
      <last_name>Marcela Kralovcova, MD</last_name>
      <phone>+420 377 103 173</phone>
      <email>kralovcovam@fnplzen.cz</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>May 31, 2023</last_update_submitted>
  <last_update_submitted_qc>May 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charles University, Czech Republic</investigator_affiliation>
    <investigator_full_name>Thomas Karvunidis</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>sepsis</keyword>
  <keyword>septic shock</keyword>
  <keyword>immune response</keyword>
  <keyword>immunoparalysis</keyword>
  <keyword>transcriptomics</keyword>
  <keyword>flow-cytometry</keyword>
  <keyword>immunomodulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</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/NCT04448951
org study id: IMHOTEP
nct id: NCT04448951
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Detailed description of immune response and its dynamics in sepsis and septic shock patiens
      by means of transcriptomics, flow-cytometry and cytokine analysis.
observational model: Case-Control
time perspective: Prospective
measure: Immune response description - flow cytometry
time frame: 2024 - 2026
description: Detailed description of immune response analyzed by mean of flow cytometry
measure: Immune response description - transcriptomics
time frame: 2024 - 2026
description: Detailed description of immune response analyzed by mean of transcriptomic analysis
measure: Immune response description - ELISA
time frame: 2024 - 2026
description: Detailed description of immune response analyzed by mean of ELISA
measure: Diagnostic "immune status" panel
time frame: 2026 - 2028
description: Diagnostic tool for immune status assessment
arm group label: sepsis/septic shock
description: target population
arm group label: non-septic critically ill
description: demographically-matched control group
arm group label: healthy control
description: control group
intervention type: Other
intervention name: transcriptomics
description: transcriptomics
arm group label: healthy control
arm group label: non-septic critically ill
arm group label: sepsis/septic shock
intervention type: Other
intervention name: flow-cytometry
description: peripheral blood myeloid cells and lymphocytes flow-cytometry
arm group label: healthy control
arm group label: non-septic critically ill
arm group label: sepsis/septic shock
intervention type: Other
intervention name: cytokines
description: peripheral blood cytokine analysis
arm group label: healthy control
arm group label: non-septic critically ill
arm group label: sepsis/septic shock
peripheral blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Karvunidis, MD, PhD
role: Principal Investigator
affiliation: Carles University Teaching Hospital and Faculty of Medicine in Pilsen, Pilsen, Czech Republic
last name: Thomas Karvunidis, MD, Ph.D.
phone: +420 377 103 173
email: karvunidist@fnplzen.cz
last name: Marcela Královcová, MD
phone: +420 377 103 173
email: kralovcovam@fnplzen.cz
facility: 
status: Recruiting
contact: 
contact backup: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Charles University, Czech Republic
investigator full name: Thomas Karvunidis
investigator title: Principal investigator
mesh term: Sepsis
mesh term: Toxemia
mesh term: Shock, Septic
mesh term: Paralysis
mesh term: Immunologic Deficiency Syndromes