<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/NCT03260348</url>
  </required_header>
  <id_info>
    <org_study_id>201701188B0</org_study_id>
    <nct_id>NCT03260348</nct_id>
  </id_info>
  <brief_title>Acute Respiratory Distress Syndrome in Taiwan</brief_title>
  <official_title>Epidemiology and Long-term Outcomes of Patients With Acute Respiratory Distress Syndrome in Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial 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>
      The study enrolls ARDS patients in medical ICUs in 11 Hospitals in Taiwan. The epidemiology&#xD;
      and long-term outcomes of the patients will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2018</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>Epidemiology</measure>
    <time_frame>two months</time_frame>
    <description>The incidence of ARDS in intensive care unit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>90 days</time_frame>
    <description>The mortality rate of patients in hospital</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term outcome</measure>
    <time_frame>5 years</time_frame>
    <description>Performance status of live patients discharged.</description>
  </primary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients in medical intensive care unit during study period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Patients in medical intensive care unit in Sep., 2017 and Jan., 2018.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years.&#xD;
&#xD;
          -  Pregnancy.&#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>Kuo-Chin Kao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kuo-Chin Kao</last_name>
    <email>kck0502@cgmh.org.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tsang-Tang Hsieh</last_name>
    <phone>886-3-3196200</phone>
    <phone_ext>3711</phone_ext>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</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/NCT03260348
org study id: 201701188B0
nct id: NCT03260348
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study enrolls ARDS patients in medical ICUs in 11 Hospitals in Taiwan. The epidemiology
      and long-term outcomes of the patients will be recorded.
observational model: Cohort
time perspective: Prospective
measure: Epidemiology
time frame: two months
description: The incidence of ARDS in intensive care unit
measure: Mortality
time frame: 90 days
description: The mortality rate of patients in hospital
measure: Long-term outcome
time frame: 5 years
description: Performance status of live patients discharged.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kuo-Chin Kao
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
last name: Kuo-Chin Kao
email: kck0502@cgmh.org.tw
last name: Tsang-Tang Hsieh
phone: 886-3-3196200
phone ext: 3711
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome
sharing ipd: No