<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/NCT03249246</url>
  </required_header>
  <id_info>
    <org_study_id>TurkishICS</org_study_id>
    <nct_id>NCT03249246</nct_id>
  </id_info>
  <brief_title>Epidemiology of Sepsis in Turkish ICUs.</brief_title>
  <official_title>Epidemiology of Sepsis in Turkish ICUs :a National Point Prevalence Multi-centre Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nur Baykara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Turkish Society of Intensive Care, Sepsis Study Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Turkish Intensive Care Society</source>
  <oversight_info>
    <has_dmc>Yes</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 prevalence and mortality of sepsis in Turkey is not know at large. Turkish Society of&#xD;
      Intensive Care Medicine, Sepsis Study Group conducted a multi-centre,point prevalence survey&#xD;
      to determine the prevalence, causative micro-organisms and outcome of sepsis in Turkish ICUs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2016</start_date>
  <completion_date type="Actual">February 27, 2016</completion_date>
  <primary_completion_date type="Actual">January 28, 2016</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of sepsis</measure>
    <time_frame>Up to 12 weeks.</time_frame>
    <description>The prevalence of sepsis,Severe sepsis and septic shock on study day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality rate of sepsis</measure>
    <time_frame>Mortality at 30 days</time_frame>
    <description>Mortality rate of septic shock</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">1499</enrollment>
  <condition>Sepsis</condition>
  <condition>Septic Shock</condition>
  <condition>Severe Sepsis</condition>
  <arm_group>
    <arm_group_label>Infection only</arm_group_label>
    <description>The patients have only infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infection + SIRS</arm_group_label>
    <description>Patients have infection plus systemic inflammatory response syndrome (SIRS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe sepsis</arm_group_label>
    <description>Septic patients with newly developed organ dysfunctions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Septic shock</arm_group_label>
    <description>Sepsis plus sepsis related hypotension</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <arm_group_label>Infection + SIRS</arm_group_label>
    <arm_group_label>Infection only</arm_group_label>
    <arm_group_label>Septic shock</arm_group_label>
    <arm_group_label>Severe sepsis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients (&gt;18 yr)present on the participating ICU or admitted to participating ICUs on&#xD;
        study day&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:All patients present on or admitted to participating ICU on study day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&lt;18 years&#xD;
&#xD;
          -  Patients who underwent cardiovascular surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Rhodes A, Phillips G, Beale R, Cecconi M, Chiche JD, De Backer D, Divatia J, Du B, Evans L, Ferrer R, Girardis M, Koulenti D, Machado F, Simpson SQ, Tan CC, Wittebole X, Levy M. The Surviving Sepsis Campaign bundles and outcome: results from the International Multicentre Prevalence Study on Sepsis (the IMPreSS study). Intensive Care Med. 2015 Sep;41(9):1620-8. doi: 10.1007/s00134-015-3906-y. Epub 2015 Jun 25.</citation>
    <PMID>26109396</PMID>
  </reference>
  <reference>
    <citation>Falagas ME, Rafailidis PI, Kofteridis D, Virtzili S, Chelvatzoglou FC, Papaioannou V, Maraki S, Samonis G, Michalopoulos A. Risk factors of carbapenem-resistant Klebsiella pneumoniae infections: a matched case control study. J Antimicrob Chemother. 2007 Nov;60(5):1124-30. doi: 10.1093/jac/dkm356. Epub 2007 Sep 20.</citation>
    <PMID>17884829</PMID>
  </reference>
  <results_reference>
    <citation>Fleischmann C, Scherag A, Adhikari NK, Hartog CS, Tsaganos T, Schlattmann P, Angus DC, Reinhart K; International Forum of Acute Care Trialists. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med. 2016 Feb 1;193(3):259-72. doi: 10.1164/rccm.201504-0781OC.</citation>
    <PMID>26414292</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 11, 2017</last_update_submitted>
  <last_update_submitted_qc>August 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Turkish Intensive Care Society</investigator_affiliation>
    <investigator_full_name>Nur Baykara</investigator_full_name>
    <investigator_title>Prof.Dr.Nur Baykara</investigator_title>
  </responsible_party>
  <keyword>Sepsis</keyword>
  <keyword>ICU</keyword>
  <keyword>Point prevalence</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/NCT03249246
org study id: TurkishICS
nct id: NCT03249246
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The prevalence and mortality of sepsis in Turkey is not know at large. Turkish Society of
      Intensive Care Medicine, Sepsis Study Group conducted a multi-centre,point prevalence survey
      to determine the prevalence, causative micro-organisms and outcome of sepsis in Turkish ICUs.
observational model: Cohort
time perspective: Cross-Sectional
measure: Prevalence of sepsis
time frame: Up to 12 weeks.
description: The prevalence of sepsis,Severe sepsis and septic shock on study day
measure: Mortality rate of sepsis
time frame: Mortality at 30 days
description: Mortality rate of septic shock
arm group label: Infection only
description: The patients have only infection
arm group label: Infection + SIRS
description: Patients have infection plus systemic inflammatory response syndrome (SIRS)
arm group label: Severe sepsis
description: Septic patients with newly developed organ dysfunctions
arm group label: Septic shock
description: Sepsis plus sepsis related hypotension
intervention type: Other
intervention name: No intervention
arm group label: Infection + SIRS
arm group label: Infection only
arm group label: Septic shock
arm group label: Severe sepsis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
citation: Rhodes A, Phillips G, Beale R, Cecconi M, Chiche JD, De Backer D, Divatia J, Du B, Evans L, Ferrer R, Girardis M, Koulenti D, Machado F, Simpson SQ, Tan CC, Wittebole X, Levy M. The Surviving Sepsis Campaign bundles and outcome: results from the International Multicentre Prevalence Study on Sepsis (the IMPreSS study). Intensive Care Med. 2015 Sep;41(9):1620-8. doi: 10.1007/s00134-015-3906-y. Epub 2015 Jun 25.
PMID: 26109396
citation: Falagas ME, Rafailidis PI, Kofteridis D, Virtzili S, Chelvatzoglou FC, Papaioannou V, Maraki S, Samonis G, Michalopoulos A. Risk factors of carbapenem-resistant Klebsiella pneumoniae infections: a matched case control study. J Antimicrob Chemother. 2007 Nov;60(5):1124-30. doi: 10.1093/jac/dkm356. Epub 2007 Sep 20.
PMID: 17884829
citation: Fleischmann C, Scherag A, Adhikari NK, Hartog CS, Tsaganos T, Schlattmann P, Angus DC, Reinhart K; International Forum of Acute Care Trialists. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med. 2016 Feb 1;193(3):259-72. doi: 10.1164/rccm.201504-0781OC.
PMID: 26414292
responsible party type: Sponsor-Investigator
investigator affiliation: Turkish Intensive Care Society
investigator full name: Nur Baykara
investigator title: Prof.Dr.Nur Baykara
mesh term: Sepsis
mesh term: Toxemia
sharing ipd: No