<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/NCT03796715</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU R76/2018</org_study_id>
    <nct_id>NCT03796715</nct_id>
  </id_info>
  <brief_title>Red Cell Distribution Width Versus Presepsin (Soluble CD14) as a Prognostic Marker in Critically-ill Sepsis Patients</brief_title>
  <official_title>Comparison of Red Cell Distribution Width Versus Presepsin (Soluble CD14) for Prognosis Assessment in Sepsis Patients Admitted to the Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      Presepsin (soluble CD14 subtype) is a novel marker with growing body of evidence supporting&#xD;
      its accuracy and value for the diagnosis of sepsis. Patients with sepsis showed higher&#xD;
      Prsepsin levels compared to those with SIRS. In addition the increase in Prsepsin levels&#xD;
      correlates well with sepsis severity. Red cell distribution width variations are increased in&#xD;
      a variety of medical conditions such as congestive heart failure, acute myocardial&#xD;
      infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a&#xD;
      predictor of mortality in the general population. we aim to compare between Presepsin&#xD;
      (soluble CD14) and RDW as prognostic markers in critically-ill patients with sepsis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">December 24, 2018</completion_date>
  <primary_completion_date type="Actual">November 20, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality during intensive care unit stay</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>assessed up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for readmission to ICU</measure>
    <time_frame>assessed up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory support duration</measure>
    <time_frame>assessed up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who need renal replacement therapy</measure>
    <time_frame>assessed up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who need inotropic or vasopressor support</measure>
    <time_frame>assessed up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion requirements (blood and blood products)</measure>
    <time_frame>assessed up to 3 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Red Cell Distribution Width (RDW)</arm_group_label>
    <description>RDW was assessed as part of complete blood count analysis using SYSMEX XN-550 automated analyzer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Presepsin (sCD14-ST)</arm_group_label>
    <description>Presepsin analysis was done by utilising Elisa technique using kits from (MyBioSource, San Diego, CA 92195-3308 USA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Red Cell Distribution Width (RDW)</intervention_name>
    <description>A total of 100 sepsis patients, Red Cell Distribution Width (RDW) was used as prognostic marker.</description>
    <arm_group_label>Red Cell Distribution Width (RDW)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Presepsin (sCD14-ST)</intervention_name>
    <description>: A total of 100 sepsis patients, Presepsin (sCD14-ST) was used as prognostic marker.</description>
    <arm_group_label>Presepsin (sCD14-ST)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the general ICU with sepsis or septic shock of both sexes between 18&#xD;
        and 65 years of age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 18 65 years.&#xD;
&#xD;
          -  Appropriate clinical data to enable classification into sepsis or SIRS according to&#xD;
             Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).&#xD;
&#xD;
          -  Written informed consent by the patient or guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No informed consent&#xD;
&#xD;
          -  Renal failure&#xD;
&#xD;
          -  Liver failure&#xD;
&#xD;
          -  Hematologic diseases&#xD;
&#xD;
          -  Neutropenia&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Chemotherapy during the previous 90 days.&#xD;
&#xD;
          -  Patients using antibiotics at presentation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Elsayed</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams University Hospitals</name>
      <address>
        <city>Cairo</city>
        <zip>11591</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ahmed Elsayed</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sepsis</keyword>
  <keyword>presepsin</keyword>
  <keyword>red cell distribution width</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>Undecided</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/NCT03796715
org study id: FMASU R76/2018
nct id: NCT03796715
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Presepsin (soluble CD14 subtype) is a novel marker with growing body of evidence supporting
      its accuracy and value for the diagnosis of sepsis. Patients with sepsis showed higher
      Prsepsin levels compared to those with SIRS. In addition the increase in Prsepsin levels
      correlates well with sepsis severity. Red cell distribution width variations are increased in
      a variety of medical conditions such as congestive heart failure, acute myocardial
      infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a
      predictor of mortality in the general population. we aim to compare between Presepsin
      (soluble CD14) and RDW as prognostic markers in critically-ill patients with sepsis.
observational model: Cohort
time perspective: Retrospective
measure: Mortality during intensive care unit stay
time frame: 28 days
measure: Length of ICU stay
time frame: assessed up to 3 months
measure: Need for readmission to ICU
time frame: assessed up to 3 months
measure: Ventilatory support duration
time frame: assessed up to 3 months
measure: Number of participants who need renal replacement therapy
time frame: assessed up to 3 months
measure: Number of participants who need inotropic or vasopressor support
time frame: assessed up to 3 months
measure: Transfusion requirements (blood and blood products)
time frame: assessed up to 3 months
arm group label: Red Cell Distribution Width (RDW)
description: RDW was assessed as part of complete blood count analysis using SYSMEX XN-550 automated analyzer
arm group label: Presepsin (sCD14-ST)
description: Presepsin analysis was done by utilising Elisa technique using kits from (MyBioSource, San Diego, CA 92195-3308 USA)
intervention type: Diagnostic Test
intervention name: Red Cell Distribution Width (RDW)
description: A total of 100 sepsis patients, Red Cell Distribution Width (RDW) was used as prognostic marker.
arm group label: Red Cell Distribution Width (RDW)
intervention type: Diagnostic Test
intervention name: Presepsin (sCD14-ST)
description: : A total of 100 sepsis patients, Presepsin (sCD14-ST) was used as prognostic marker.
arm group label: Presepsin (sCD14-ST)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ahmed Elsayed
role: Principal Investigator
affiliation: Ain Shams University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ahmed Elsayed
investigator title: Principal Investigator
mesh term: Sepsis
mesh term: Toxemia
sharing ipd: Undecided