<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/NCT04480515</url>
  </required_header>
  <id_info>
    <org_study_id>KSSEAH--IHM</org_study_id>
    <nct_id>NCT04480515</nct_id>
  </id_info>
  <brief_title>Does COVID-19 Pandemic Reduce In-hospital Mortality?</brief_title>
  <official_title>Does COVID-19 Pandemic Reduce In-hospital Mortality?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to&#xD;
      many countries of the world. Although it is suggested that hospital admissions are reduced&#xD;
      due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether&#xD;
      in-hospital mortality rates changed. Therefore this multi-centered study aimed to determine&#xD;
      how in-hospital mortality effected during the pandemic period according to the specific&#xD;
      patient groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to&#xD;
      many countries of the world. Although it is suggested that hospital admissions are reduced&#xD;
      due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether&#xD;
      in-hospital mortality rates changed. Therefore this multi-centered study aimed to determine&#xD;
      how in-hospital mortality effected during the pandemic period according to the specific&#xD;
      patient groups. Thus, in case of a pandemic, it will be a guide in which patient groups&#xD;
      healthcare providers should be more careful about.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 15, 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>In-hospital mortality</measure>
    <time_frame>4 months</time_frame>
    <description>During the pandemic (March-July), deaths occurred in hospital will be evaluated.</description>
  </primary_outcome>
  <enrollment type="Actual">5000</enrollment>
  <condition>Covid19</condition>
  <condition>In-hospital Cardiac Arrest</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>in-hospital mortality rate</intervention_name>
    <description>In-hospital mortality rate during pandemic of 2020 will be compared with the in-hospital mortality rate of the last year's same time period</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All the records of in-hospital mortality will be evaluated&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Deaths, with all required data available, occurred within the study hospitals&#xD;
&#xD;
          -  centers Accepted to participate with an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lack of consent&#xD;
&#xD;
          -  lack of data&#xD;
&#xD;
          -  deaths occurred outside the study hospitals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kanuni Sultan Suleyman Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34303</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ramazan Guven</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04480515
org study id: KSSEAH--IHM
nct id: NCT04480515
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to
      many countries of the world. Although it is suggested that hospital admissions are reduced
      due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether
      in-hospital mortality rates changed. Therefore this multi-centered study aimed to determine
      how in-hospital mortality effected during the pandemic period according to the specific
      patient groups.
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to
      many countries of the world. Although it is suggested that hospital admissions are reduced
      due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether
      in-hospital mortality rates changed. Therefore this multi-centered study aimed to determine
      how in-hospital mortality effected during the pandemic period according to the specific
      patient groups. Thus, in case of a pandemic, it will be a guide in which patient groups
      healthcare providers should be more careful about.
observational model: Cohort
time perspective: Other
measure: In-hospital mortality
time frame: 4 months
description: During the pandemic (March-July), deaths occurred in hospital will be evaluated.
intervention type: Other
intervention name: in-hospital mortality rate
description: In-hospital mortality rate during pandemic of 2020 will be compared with the in-hospital mortality rate of the last year's same time period
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Ramazan Guven
investigator title: Professor
mesh term: COVID-19
sharing ipd: No