<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/NCT04459572</url>
  </required_header>
  <id_info>
    <org_study_id>TGA-2019-20230</org_study_id>
    <nct_id>NCT04459572</nct_id>
  </id_info>
  <brief_title>As an Early Indicator Biomarker of Prognosis and Mortality in Children With Sepsis and Septic Shock: suPAR</brief_title>
  <acronym>suPAR</acronym>
  <official_title>The Investigation of Soluble Urokinase Plasminogen Activator Receptor (suPAR) as an Early Indicator of Prognosis and Mortality in Children With Sepsis and Septic Shock: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ege University</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>
      The sepsis and septic shock remain major causes of child morbidity and mortality, despite the&#xD;
      use of modern antibiotics and resuscitation therapies. Recent interest has focused on&#xD;
      biomarkers for early diagnosis, and evaluation the outcomes of sepsis; but there is a still&#xD;
      lack of early diagnosis and timely intervention for sepsis in the emergency department (ED).&#xD;
      The primary aim was to investigate the role of C-Reactive Protein(CRP), Procalcitonin(PCT),&#xD;
      soluble-urokinase plasminogen activator receptor(suPAR) and Presepsin in the early&#xD;
      stratification of patients with sepsis. The usefulness of pediatric Sequential Organ Failure&#xD;
      Assessment (pSOFA) for predicting of the mortality and the rate of PICU admission in children&#xD;
      with septik shock were also investigated. This prospective pilot study was conducted at&#xD;
      academic pediatric ED between September 2017-June 2018. All children who met sepsis criteria&#xD;
      admitted to ED were involved to study. They kept following up after ED management and their&#xD;
      blood samples were taken upon admission on day 0, 1, 2, 4 and 7. The definition made as&#xD;
      sepsis, severe sepsis and septic shock. At the same period, 100 healthy children chosen as&#xD;
      the control group. The patient characteristics, clinical features, diagnosis, co-morbidities,&#xD;
      source of infection, laboratory results (CRP, PCT, lactate, suPAR and Presepsin) and&#xD;
      treatments were recorded. The pSOFA score was calculated during first hour of admission.&#xD;
      Length of stay in ED and hospital was noted. The main outcome measure was in 7 and 30-day&#xD;
      mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2019</start_date>
  <completion_date type="Actual">June 25, 2020</completion_date>
  <primary_completion_date type="Actual">September 27, 2019</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>suPAR values in septic chock</measure>
    <time_frame>7 days</time_frame>
    <description>The usefulness of soluble urokinase type plasminogen activator receptor (suPAR) for predicting of the mortality and the rate of PICU admission in children with septik shock</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presepsin level</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-Reactive Protein(CRP) level</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procalcitonin (PCT) level</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Septic Shock</condition>
  <condition>Sepsis, Severe</condition>
  <arm_group>
    <arm_group_label>Sepsis and sepstic shock</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The study consists patients and healty-control group. Patients divided into 3 groups based on severity: sepsis, severe sepsis and septic shock</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>suPAR</intervention_name>
    <description>Soluble Urokinase Plasminogen Activator Receptor (suPAR)</description>
    <arm_group_label>Sepsis and sepstic shock</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years&#xD;
&#xD;
          -  Admitted to emergency department with sepsis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years&#xD;
&#xD;
          -  Diagnosed non-sepsis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ege University School of Medicine</name>
      <address>
        <city>İzmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ege University</investigator_affiliation>
    <investigator_full_name>Caner Turan</investigator_full_name>
    <investigator_title>Director, MD</investigator_title>
  </responsible_party>
  <keyword>sepsis</keyword>
  <keyword>suPAR</keyword>
  <keyword>septic shock</keyword>
  <keyword>children</keyword>
  <keyword>mortality</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>Shock</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/NCT04459572
org study id: TGA-2019-20230
nct id: NCT04459572
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The sepsis and septic shock remain major causes of child morbidity and mortality, despite the
      use of modern antibiotics and resuscitation therapies. Recent interest has focused on
      biomarkers for early diagnosis, and evaluation the outcomes of sepsis; but there is a still
      lack of early diagnosis and timely intervention for sepsis in the emergency department (ED).
      The primary aim was to investigate the role of C-Reactive Protein(CRP), Procalcitonin(PCT),
      soluble-urokinase plasminogen activator receptor(suPAR) and Presepsin in the early
      stratification of patients with sepsis. The usefulness of pediatric Sequential Organ Failure
      Assessment (pSOFA) for predicting of the mortality and the rate of PICU admission in children
      with septik shock were also investigated. This prospective pilot study was conducted at
      academic pediatric ED between September 2017-June 2018. All children who met sepsis criteria
      admitted to ED were involved to study. They kept following up after ED management and their
      blood samples were taken upon admission on day 0, 1, 2, 4 and 7. The definition made as
      sepsis, severe sepsis and septic shock. At the same period, 100 healthy children chosen as
      the control group. The patient characteristics, clinical features, diagnosis, co-morbidities,
      source of infection, laboratory results (CRP, PCT, lactate, suPAR and Presepsin) and
      treatments were recorded. The pSOFA score was calculated during first hour of admission.
      Length of stay in ED and hospital was noted. The main outcome measure was in 7 and 30-day
      mortality.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: suPAR values in septic chock
time frame: 7 days
description: The usefulness of soluble urokinase type plasminogen activator receptor (suPAR) for predicting of the mortality and the rate of PICU admission in children with septik shock
measure: Presepsin level
time frame: 7 days
measure: C-Reactive Protein(CRP) level
time frame: 7 days
measure: Procalcitonin (PCT) level
time frame: 7 days
arm group label: Sepsis and sepstic shock
arm group type: Other
description: The study consists patients and healty-control group. Patients divided into 3 groups based on severity: sepsis, severe sepsis and septic shock
intervention type: Diagnostic Test
intervention name: suPAR
description: Soluble Urokinase Plasminogen Activator Receptor (suPAR)
arm group label: Sepsis and sepstic shock
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ege University
investigator full name: Caner Turan
investigator title: Director, MD
mesh term: Sepsis
mesh term: Toxemia
mesh term: Shock, Septic
mesh term: Shock
sharing ipd: No