<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/NCT04411368</url>
  </required_header>
  <id_info>
    <org_study_id>ICU_RES_VIRUS</org_study_id>
    <nct_id>NCT04411368</nct_id>
  </id_info>
  <brief_title>Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure</brief_title>
  <official_title>Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul St. Mary's 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>
      This is an observational study to evaluate the clinical impact of respiratory virus in the&#xD;
      patients with acute respiratory failure&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of respiratory viral infections</measure>
    <time_frame>within 24 hours after intensive care unit (ICU) admission</time_frame>
    <description>Rate of respiratory viral infections in patients with acute respiratory failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU mortality rate</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Association between respiratory viral infections and death in ICU and risk factors of death in patients with ARF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality rate</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Association between respiratory viral infections and death in hospital and risk factors of death in patients with ARF</description>
  </secondary_outcome>
  <enrollment type="Anticipated">540</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Nasopharyngeal aspirates, Sputum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with presentation to ICU with critical illness compatible with acute respiratory&#xD;
        failrue.&#xD;
&#xD;
        * Definition of acute respiratory failure: Patients who met one of following criteria&#xD;
&#xD;
          1. SaO2 &lt; 90% on room air&#xD;
&#xD;
          2. SaO2 &lt; 92% on &gt; 6L/min of oxygen&#xD;
&#xD;
          3. Respiratory rates &gt; 30/min, or sign of respiratory distress&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged ≥ 19 years&#xD;
&#xD;
          -  Written informed consent by the patient or legally authorized representative&#xD;
&#xD;
          -  Critical illness consistent with acute respiratory failure, to be enrolled within 24&#xD;
             hours of presentation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No informed consent&#xD;
&#xD;
          -  A patient who is judged to be unable to make a voluntary decision by understanding&#xD;
             information about this research due to cognitive vulnerability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jongmin Lee</last_name>
    <role>Study Director</role>
    <affiliation>Seoul St. Mary's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jongmin Lee, Ph.D</last_name>
    <phone>+821063007128</phone>
    <email>dibs03@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jongmin Lee, M.D.</last_name>
      <phone>82-10-6300-7128</phone>
      <email>dibs03@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul St. Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Jongmin Lee</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
  </condition_browse>
  <!-- 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/NCT04411368
org study id: ICU_RES_VIRUS
nct id: NCT04411368
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observational study to evaluate the clinical impact of respiratory virus in the
      patients with acute respiratory failure
observational model: Cohort
time perspective: Prospective
measure: Rate of respiratory viral infections
time frame: within 24 hours after intensive care unit (ICU) admission
description: Rate of respiratory viral infections in patients with acute respiratory failure
measure: ICU mortality rate
time frame: Through study completion, an average of 1 year
description: Association between respiratory viral infections and death in ICU and risk factors of death in patients with ARF
measure: Hospital mortality rate
time frame: Through study completion, an average of 1 year
description: Association between respiratory viral infections and death in hospital and risk factors of death in patients with ARF
Nasopharyngeal aspirates, Sputum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Jongmin Lee
role: Study Director
affiliation: Seoul St. Mary's Hospital
last name: Jongmin Lee, Ph.D
phone: +821063007128
email: dibs03@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul St. Mary's Hospital
investigator full name: Jongmin Lee
investigator title: Assistant professor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
mesh term: Acute Lung Injury