<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/NCT03811483</url>
  </required_header>
  <id_info>
    <org_study_id>Sepsis-FluidsandGender</org_study_id>
    <nct_id>NCT03811483</nct_id>
  </id_info>
  <brief_title>SepsisFLAGS ( FLuidAndGender)</brief_title>
  <acronym>FLAGS</acronym>
  <official_title>Fluid Treatment and the Impact of Gender in a Septic Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</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>
      In this single-center study the investigators will analyze gender differences among patients&#xD;
      with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period&#xD;
      of two years. About 11 000 patients will be included. Patient data including fluid therapy&#xD;
      will be drawn from the electronic medical record; Take Care and Clinisoft. In the logistic&#xD;
      regression analysis, the investigators will adjust for age, gender, comorbidities, vital&#xD;
      signs, preliminary focus of infection, level of care and renal replacement therapy. The aim&#xD;
      is to analyze gender differences in fluid treatment and the response to fluid treatment and&#xD;
      if the treatment is associated with differences in mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2020</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Gender differences in fluid treatment</measure>
    <time_frame>Fluid therapy during the first six hours (adherence to sepsis bundles) and the first five days after admission.</time_frame>
    <description>Millilitres of fluid given per kilogram of patient weight (ml/kg).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between amount of fluid and mortality</measure>
    <time_frame>In-Hospital Mortality, 30- and 90-days mortality</time_frame>
    <description>Analyze the whole cohort and female/ male gender as subgroups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of fluids</measure>
    <time_frame>First five days after admission.</time_frame>
    <description>Type according to Anatomical, Therapeutic and Chemical Classification System</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between fluid therapy and levels of lactat</measure>
    <time_frame>First five days efter admission</time_frame>
    <description>Analyze the whole cohort and female/ male gender as subgroups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between fluid therapy and need for/ dose of vasopressors/inotropic drugs</measure>
    <time_frame>First five days efter admission</time_frame>
    <description>Analyze the whole cohort and female/ male gender as subgroups</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Female gender</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Male gender</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The population is patients admitted at the emergency department at Södersjukhuset in&#xD;
        Southern Stockholm. Södersjukhuset has 600 hospital beds and manages most medical fields&#xD;
        except for highly specialized care for example neuro and thoracic surgery. 130 000 patients&#xD;
        are seeking medical care yearly which makes the emergency department at Södersjukhuset the&#xD;
        most frequented in Scandinavia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to the emergency department with suspected sepsis (defined by blood&#xD;
             culture taken and intravenous sepsis-antibiotics prescribed within 48 hours) and&#xD;
             fulfilling sepsis-3 definition of sepsis (sequential organ failure assesment score of&#xD;
             2 or more)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients transferred from other hospitals or treatment clinics.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra Jonmarker</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet, Södersjukhuset</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sandra Jonmarker</last_name>
    <phone>+4686162238</phone>
    <phone_ext>+46709676710</phone_ext>
    <email>sandra.jonmarker@sll.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria Cronhjort, Ph D</last_name>
    <phone>+4686162965</phone>
    <phone_ext>+46735671555</phone_ext>
    <email>maria.cronhjort@sll.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Södersjukhuset</name>
      <address>
        <city>Stockholm</city>
        <state>Stockholms Län</state>
        <zip>11880</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <contact>
      <last_name>Sandra Jonmarker</last_name>
      <phone>+4686162238</phone>
      <phone_ext>+46709676710</phone_ext>
      <email>sandra.jonmarker@sll.se</email>
    </contact>
    <contact_backup>
      <last_name>Maria Cronhjort, PhD</last_name>
      <phone>+4686162965</phone>
      <phone_ext>+46735671555</phone_ext>
      <email>maria.cronhjort@sll.se</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Christer Svensen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Fluid Therapy</keyword>
  <keyword>Gender difference</keyword>
  <!-- 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/NCT03811483
org study id: Sepsis-FluidsandGender
nct id: NCT03811483
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this single-center study the investigators will analyze gender differences among patients
      with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period
      of two years. About 11 000 patients will be included. Patient data including fluid therapy
      will be drawn from the electronic medical record; Take Care and Clinisoft. In the logistic
      regression analysis, the investigators will adjust for age, gender, comorbidities, vital
      signs, preliminary focus of infection, level of care and renal replacement therapy. The aim
      is to analyze gender differences in fluid treatment and the response to fluid treatment and
      if the treatment is associated with differences in mortality.
observational model: Cohort
time perspective: Other
measure: Gender differences in fluid treatment
time frame: Fluid therapy during the first six hours (adherence to sepsis bundles) and the first five days after admission.
description: Millilitres of fluid given per kilogram of patient weight (ml/kg).
measure: Association between amount of fluid and mortality
time frame: In-Hospital Mortality, 30- and 90-days mortality
description: Analyze the whole cohort and female/ male gender as subgroups
measure: Type of fluids
time frame: First five days after admission.
description: Type according to Anatomical, Therapeutic and Chemical Classification System
measure: Association between fluid therapy and levels of lactat
time frame: First five days efter admission
description: Analyze the whole cohort and female/ male gender as subgroups
measure: Association between fluid therapy and need for/ dose of vasopressors/inotropic drugs
time frame: First five days efter admission
description: Analyze the whole cohort and female/ male gender as subgroups
arm group label: Female gender
arm group label: Male gender
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sandra Jonmarker
role: Principal Investigator
affiliation: Karolinska Institutet, Södersjukhuset
last name: Sandra Jonmarker
phone: +4686162238
phone ext: +46709676710
email: sandra.jonmarker@sll.se
last name: Maria Cronhjort, Ph D
phone: +4686162965
phone ext: +46735671555
email: maria.cronhjort@sll.se
facility: 
contact: 
contact backup: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Christer Svensen
investigator title: Professor