<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/NCT04430023</url>
  </required_header>
  <id_info>
    <org_study_id>DM3334</org_study_id>
    <nct_id>NCT04430023</nct_id>
  </id_info>
  <brief_title>Epidemiological and Demographic Data From 150 Patients Diagnosed With Coronavirus Disease 2019 Pneumonia</brief_title>
  <official_title>Epidemiological and Demographic Data From 150 Patients Diagnosed With Coronavirus Disease 2019 Pneumonia in Intensive Care Unit- a Retrospective, Observational Study in Istanbul, Turkey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sisli Hamidiye Etfal Training and Research Hospital</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 study, the investigator examined epidemiological and demographic characteristics,&#xD;
      risk factors and 28-day mortality of patients admitted to the intensive care unit with the&#xD;
      diagnosis of coronavirus disease 2019 pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients with intensive care requirements were admitted from emergency department and&#xD;
      coronavirus disease 2019 wards to our units. The criteria for intensive care requirement was&#xD;
      identified as oxygen saturation&lt;90%, partial oxygen pressure&lt;70 mmHg, respiratory rate&gt;&#xD;
      30/min or PaO2/FiO2(partial oxygen pressure/fraction of inspired oxygen) &lt;300 despite&#xD;
      conventional oxygen treatment of 5lt/min. Primary objective was the effect of defined data on&#xD;
      28-day mortality, and secondary objective was the impact of lymphocyte count, lactate&#xD;
      dehydrogenase, ferritin, D-dimer and procalcitonin levels, and SOFA(Sequential Organ Failure&#xD;
      Assessment) score on prognosis, which are among the risk factors determined by previous&#xD;
      studies. All data were evaluated and recorded using the standardized International Severe&#xD;
      Acute Respiratory and Emerging Infection Consortium (ISARIC) case report forms, complemented&#xD;
      by electronic records of the hospital, nurse observation records, and missing information was&#xD;
      completed by telephone interviews with patients' relatives.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">June 5, 2020</completion_date>
  <primary_completion_date type="Actual">June 3, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mortality</measure>
    <time_frame>up to 28 days</time_frame>
    <description>mortality rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>demographic characteristics</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Patients' age, gender, BMI, medical history</description>
  </primary_outcome>
  <enrollment type="Actual">150</enrollment>
  <condition>Corona Virus Infection</condition>
  <condition>Pneumonia</condition>
  <condition>Acute Respiratory Failure</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>epidemiological and demographic characteristics</intervention_name>
    <description>Patients' age, gender, BMI, medical history, symptoms at admission (e.g., cough, fever, myalgia, gastrointestinal symptoms, headache), concomitant diseases (e.g., diabetes mellitus, hypertension, chronic lung disease, cerebrovascular disease, kidney disease, heart disease, cancer, smoking</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study was planned retrospectively, cross-sectionally and observationally with 193&#xD;
        patients hospitalized between 16 March 2020 and 15 May 2020 in five different coronavirus&#xD;
        disease 2019 intensive care units in two campuses of our hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study was planned retrospectively, cross-sectionally and observationally with 193&#xD;
             patients hospitalized between 16 March 2020 and 15 May 2020 in five different&#xD;
             coronavirus disease 2019 intensive care units in two campuses of our hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Health workers, patients hospitalized less than 24 hours, patients with negative&#xD;
             polymerase chain reaction tests, and patients who returned to intensive care unit&#xD;
             after discharge were excluded from the study.&#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>ayse cinar</last_name>
    <role>Principal Investigator</role>
    <affiliation>chief of anesthesia department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sisli Etfal Research and Training Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Marmara</state>
        <zip>34371</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.</citation>
    <PMID>32105637</PMID>
  </results_reference>
  <results_reference>
    <citation>Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.</citation>
    <PMID>31986261</PMID>
  </results_reference>
  <results_reference>
    <citation>Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271.</citation>
    <PMID>26493592</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>AYŞE SÜRHAN ÇINAR</investigator_full_name>
    <investigator_title>head of anesthesiology</investigator_title>
  </responsible_party>
  <keyword>coronavirus disease 2019</keyword>
  <keyword>pneumonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT04430023/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT04430023/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04430023
org study id: DM3334
nct id: NCT04430023
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the investigator examined epidemiological and demographic characteristics,
      risk factors and 28-day mortality of patients admitted to the intensive care unit with the
      diagnosis of coronavirus disease 2019 pneumonia.
The patients with intensive care requirements were admitted from emergency department and
      coronavirus disease 2019 wards to our units. The criteria for intensive care requirement was
      identified as oxygen saturation<90%, partial oxygen pressure<70 mmHg, respiratory rate>
      30/min or PaO2/FiO2(partial oxygen pressure/fraction of inspired oxygen) <300 despite
      conventional oxygen treatment of 5lt/min. Primary objective was the effect of defined data on
      28-day mortality, and secondary objective was the impact of lymphocyte count, lactate
      dehydrogenase, ferritin, D-dimer and procalcitonin levels, and SOFA(Sequential Organ Failure
      Assessment) score on prognosis, which are among the risk factors determined by previous
      studies. All data were evaluated and recorded using the standardized International Severe
      Acute Respiratory and Emerging Infection Consortium (ISARIC) case report forms, complemented
      by electronic records of the hospital, nurse observation records, and missing information was
      completed by telephone interviews with patients' relatives.
observational model: Other
time perspective: Retrospective
measure: mortality
time frame: up to 28 days
description: mortality rate
measure: demographic characteristics
time frame: up to 28 days
description: Patients' age, gender, BMI, medical history
intervention type: Other
intervention name: epidemiological and demographic characteristics
description: Patients' age, gender, BMI, medical history, symptoms at admission (e.g., cough, fever, myalgia, gastrointestinal symptoms, headache), concomitant diseases (e.g., diabetes mellitus, hypertension, chronic lung disease, cerebrovascular disease, kidney disease, heart disease, cancer, smoking
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ayse cinar
role: Principal Investigator
affiliation: chief of anesthesia department
facility: 
country: Turkey
citation: Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.
PMID: 32105637
citation: Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.
PMID: 31986261
citation: Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271.
PMID: 26493592
responsible party type: Principal Investigator
investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
investigator full name: AYŞE SÜRHAN ÇINAR
investigator title: head of anesthesiology
mesh term: Pneumonia
mesh term: Coronavirus Infections
mesh term: COVID-19
mesh term: Respiratory Insufficiency
sharing ipd: No
provided document: 
provided document: 