<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/NCT03280576</url>
  </required_header>
  <id_info>
    <org_study_id>Progranulin_1</org_study_id>
    <nct_id>NCT03280576</nct_id>
  </id_info>
  <brief_title>Validation of Progranulin as a Biomarker for Sepsis</brief_title>
  <acronym>PROGRANULIN</acronym>
  <official_title>Sensitivity and Specificity of Progranulin as a Biomarker for Sepsis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>City of Munich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Progranulin blood concentrations in patients with sepsis will be analysed in relation to&#xD;
      disease status in order to validate progranulin as a biomarker for sepsis. Patients&#xD;
      undergoing cardiac surgery will serve as controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single nucleotide polymorphisms with known effects on Progranulin plasma concentrations will&#xD;
      be assessed in a separate analysis. Expression levels of microRNAs isolated from plasma,&#xD;
      circulating exosomes and blood cells will be determined by next-generation sequencing to&#xD;
      characterize epigenetic influences on progranulin plasma levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">April 2019</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>Change in progranulin plasma concentrations during ICU - therapy</measure>
    <time_frame>ICU admission, day 1, day 4 of ICU therapy</time_frame>
    <description>Blood samples will be taken at the abovementioned time points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in miRNA expression levels in exosomes, serum and blood cells during ICU - therapy</measure>
    <time_frame>ICU admission, day 1, day 4 of ICU therapy</time_frame>
    <description>Blood samples will be taken at the abovementioned time points</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">556</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Sepsis</arm_group_label>
    <description>Patients with sepsis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cardiac Surgery</arm_group_label>
    <description>Patients undergoing cardiac surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>Normal individuals</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, EDTA blood, blood cells (PAXGENE)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Sepsis, Patients undergoing cardiac surgery, Healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sepsis or Septic Shock defined according to SEPSIS-3 criteria - Age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No informed consent&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Immunosuppression (including transplantation)&#xD;
&#xD;
          -  Charlson Comorbidity Index &gt; 0 (healthy volunteers)&#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>Gustav Schelling, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesiology LMU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology, LMU Munich</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Anesthesiology, Klinikum Neuperlach</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81737</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 19, 2015</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>August 13, 2019</last_update_submitted>
  <last_update_submitted_qc>August 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Gustav Schelling,MD</investigator_full_name>
    <investigator_title>Senior Researcher</investigator_title>
  </responsible_party>
  <keyword>Postoperative</keyword>
  <keyword>Dysfunction Following Cardiac Surgery</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03280576
org study id: Progranulin_1
nct id: NCT03280576
lead sponsor: 
collaborator: 
has dmc: No
Progranulin blood concentrations in patients with sepsis will be analysed in relation to
      disease status in order to validate progranulin as a biomarker for sepsis. Patients
      undergoing cardiac surgery will serve as controls.
Single nucleotide polymorphisms with known effects on Progranulin plasma concentrations will
      be assessed in a separate analysis. Expression levels of microRNAs isolated from plasma,
      circulating exosomes and blood cells will be determined by next-generation sequencing to
      characterize epigenetic influences on progranulin plasma levels.
observational model: Cohort
time perspective: Prospective
measure: Change in progranulin plasma concentrations during ICU - therapy
time frame: ICU admission, day 1, day 4 of ICU therapy
description: Blood samples will be taken at the abovementioned time points
measure: Change in miRNA expression levels in exosomes, serum and blood cells during ICU - therapy
time frame: ICU admission, day 1, day 4 of ICU therapy
description: Blood samples will be taken at the abovementioned time points
arm group label: Sepsis
description: Patients with sepsis
arm group label: Cardiac Surgery
description: Patients undergoing cardiac surgery
arm group label: Healthy controls
description: Normal individuals
Serum, EDTA blood, blood cells (PAXGENE)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gustav Schelling, M.D.
role: Principal Investigator
affiliation: Department of Anaesthesiology LMU
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Gustav Schelling,MD
investigator title: Senior Researcher
mesh term: Sepsis
mesh term: Toxemia
sharing ipd: No