<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/NCT02975908</url>
  </required_header>
  <id_info>
    <org_study_id>CHARDS20160301</org_study_id>
    <nct_id>NCT02975908</nct_id>
  </id_info>
  <brief_title>A Realworld Study of Acute Respiratory Distress Syndrome in China</brief_title>
  <acronym>CHARDSnet</acronym>
  <official_title>A Realworld Study of Acute Respiratory Distress Syndrome in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangya No.2 Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangya No.1 Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Xinjiang Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Hospital Affiliated to China Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanjing General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Third Hospital Affiliated to Neimenggu Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Hospital Affiliated to Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qilu Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Hospital Affiliated to Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>No.3 Hospital of Peking University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fuxing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>China-Japan Friendship Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      ARDS is a critical respiratory disease caused by endogenous and exogenous factors. The&#xD;
      mortality of ARDS varies from 30 to 70%. In 2012, a new international diagnostic criterion&#xD;
      has been put forward. Yet, its feasibility, reliability and validity need to be tested.&#xD;
      Meanwhile, the correlation of different severity and prognosis remains unclear. As so far,&#xD;
      the epidemiological information about ARDS in China is lacking.&#xD;
&#xD;
      Investigators plan to conduct a multi-center observational study（real-life study） to&#xD;
      investigate the risk factors, morbidity, management and prognosis of ARDS in China, in order&#xD;
      to facilitate standardization of diagnosis and management of ARDS and provide basic data and&#xD;
      idea for further clinical intervention studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2015</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>28days</time_frame>
    <description>the 28days mortality after the diagnosis of ARDS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>90 days</time_frame>
    <description>The days between admission to intensive care unit(ICU) and discharge from ICU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation free days</measure>
    <time_frame>28 days</time_frame>
    <description>The days between successful weaning from mechanical ventilation and day 28 after study enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of ARDS</measure>
    <time_frame>2 years</time_frame>
    <description>The total number of acute respiratory distress syndrome(ARDS)patients in 2 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of patients</measure>
    <time_frame>2 years</time_frame>
    <description>Number of patients in each grade of severities according to Berlin definition: the number of mild, moderate and severe acute respiratory distress syndrome(ARDS) patients will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events related to treatment</measure>
    <time_frame>90 days</time_frame>
    <description>Number of patients with adverse events, include biotrauma, worsen of hemodynamics, hospital-acquired infection, patient-ventilator asynchrony, gastric distention, aspiration etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients using adjuvant drugs</measure>
    <time_frame>28 days</time_frame>
    <description>Adjuvant drugs refer to corticosteroid, sedative, analgesic and non depolarizing muscle relaxant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with high risk factors</measure>
    <time_frame>1 week</time_frame>
    <description>High risk factors for acute respiratory distress syndrome(ARDS), including endogenous factors as pneumonia, aspiration, lung contusion and drowning; the exogenous factors as extrapulmonary trauma, extra pulmonary sepsis , hypovolemic shock, pancreatitis, severe burning, drug overdose, blood transfusion，eclampsia etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with conventional respiratory support techniques</measure>
    <time_frame>28 days</time_frame>
    <description>Conventional respiratory support techniques include noninvasive positive pressure ventilation(NPPV), invasive positive pressure ventilation(include volume-controlled ventilation and pressure-controlled ventilation) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with unconventional respiratory support techniques</measure>
    <time_frame>28 days</time_frame>
    <description>Unconventional respiratory support techniques include recruitment maneuver(RM), prone position ventilation(PPV), high-frequency oscillatory ventilation(HFOV) ,extracorporeal membrane oxygenation(ECMO) and extracorporeal CO2 removal(ECCO2R)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with impaired lung function</measure>
    <time_frame>90 days, 1 year</time_frame>
    <description>The number patients with impaired lung function 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal lung CT</measure>
    <time_frame>90 days, 1 year</time_frame>
    <description>The number patients with abnormal lung CT 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).</description>
  </secondary_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This research plans to enroll 400 hospitalized patients (≥ 18 years old with main diagnosis&#xD;
        as ARDS). Sample size estimation is based on estimated mortality of ARDS hospitalized&#xD;
        patients (~5%). Study patients will be recruited from 20 hospitals across China,each&#xD;
        hospital will recruit 20 patients. Hospital selection follows a multi-stage sampling&#xD;
        strategy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age; hospitalized patients with main diagnosis as ARDS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years of age&#xD;
&#xD;
          -  Patients or their families refused to participate in the study&#xD;
&#xD;
          -  Patients diagnosed as COPD, pulmonary fibrosis or bronchiectasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Huang Xu</last_name>
    <phone>8613641345816</phone>
    <email>huangxu1122@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhan Qingyuan</last_name>
    <phone>8613911785957</phone>
    <email>dr.zhanqy@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>China - Japan Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huang Xu</last_name>
      <phone>8613641345816</phone>
      <email>huangxu1122@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Zhan Qingyuan</last_name>
      <phone>8613911785957</phone>
      <email>dr.zhanqy@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>April 5, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Chen Wang</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Acute Respiratory Distress Syndrome</keyword>
  <keyword>epidemiology</keyword>
  <keyword>clinical features</keyword>
  <keyword>management</keyword>
  <keyword>prognosis</keyword>
  <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>Undecided</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/NCT02975908
org study id: CHARDS20160301
nct id: NCT02975908
lead sponsor: 
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has dmc: Yes
ARDS is a critical respiratory disease caused by endogenous and exogenous factors. The
      mortality of ARDS varies from 30 to 70%. In 2012, a new international diagnostic criterion
      has been put forward. Yet, its feasibility, reliability and validity need to be tested.
      Meanwhile, the correlation of different severity and prognosis remains unclear. As so far,
      the epidemiological information about ARDS in China is lacking.

      Investigators plan to conduct a multi-center observational study（real-life study） to
      investigate the risk factors, morbidity, management and prognosis of ARDS in China, in order
      to facilitate standardization of diagnosis and management of ARDS and provide basic data and
      idea for further clinical intervention studies.
observational model: Case-Only
time perspective: Prospective
measure: Mortality
time frame: 28days
description: the 28days mortality after the diagnosis of ARDS
measure: Length of ICU stay
time frame: 90 days
description: The days between admission to intensive care unit(ICU) and discharge from ICU.
measure: Ventilation free days
time frame: 28 days
description: The days between successful weaning from mechanical ventilation and day 28 after study enrollment.
measure: Incidence of ARDS
time frame: 2 years
description: The total number of acute respiratory distress syndrome(ARDS)patients in 2 years.
measure: Severity of patients
time frame: 2 years
description: Number of patients in each grade of severities according to Berlin definition: the number of mild, moderate and severe acute respiratory distress syndrome(ARDS) patients will be recorded.
measure: Adverse events related to treatment
time frame: 90 days
description: Number of patients with adverse events, include biotrauma, worsen of hemodynamics, hospital-acquired infection, patient-ventilator asynchrony, gastric distention, aspiration etc.
measure: Number of patients using adjuvant drugs
time frame: 28 days
description: Adjuvant drugs refer to corticosteroid, sedative, analgesic and non depolarizing muscle relaxant.
measure: Number of patients with high risk factors
time frame: 1 week
description: High risk factors for acute respiratory distress syndrome(ARDS), including endogenous factors as pneumonia, aspiration, lung contusion and drowning; the exogenous factors as extrapulmonary trauma, extra pulmonary sepsis , hypovolemic shock, pancreatitis, severe burning, drug overdose, blood transfusion，eclampsia etc.
measure: Number of patients with conventional respiratory support techniques
time frame: 28 days
description: Conventional respiratory support techniques include noninvasive positive pressure ventilation(NPPV), invasive positive pressure ventilation(include volume-controlled ventilation and pressure-controlled ventilation) .
measure: Number of patients with unconventional respiratory support techniques
time frame: 28 days
description: Unconventional respiratory support techniques include recruitment maneuver(RM), prone position ventilation(PPV), high-frequency oscillatory ventilation(HFOV) ,extracorporeal membrane oxygenation(ECMO) and extracorporeal CO2 removal(ECCO2R)
measure: Number of patients with impaired lung function
time frame: 90 days, 1 year
description: The number patients with impaired lung function 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).
measure: Number of patients with abnormal lung CT
time frame: 90 days, 1 year
description: The number patients with abnormal lung CT 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Huang Xu
phone: 8613641345816
email: huangxu1122@sina.com
last name: Zhan Qingyuan
phone: 8613911785957
email: dr.zhanqy@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China-Japan Friendship Hospital
investigator full name: Chen Wang
investigator title: professor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome
sharing ipd: Undecided