<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/NCT03021824</url>
  </required_header>
  <id_info>
    <org_study_id>2016-6757</org_study_id>
    <nct_id>NCT03021824</nct_id>
  </id_info>
  <brief_title>Severe ARDS: Generating Evidence</brief_title>
  <acronym>SAGE</acronym>
  <official_title>Severe ARDS: Generating Evidence. A U.S. Multicenter Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An assessment of early management of moderate-severe ARDS in the United States, including&#xD;
      ventilator management and use of rescue therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately one-quarter of ARDS patients develop severe hypoxemia, which has been&#xD;
      associated with mortality rates approximating 40-50%. The majority have been described to&#xD;
      present with severe disease at baseline, suggesting an opportunity for early intervention. In&#xD;
      addition, use of evidence-based practices in severe ARDS is highly variable and inconsistent;&#xD;
      use of unproven treatment modalities is also frequently seen. Given the variability in&#xD;
      treatment practices in severe ARDS, an understanding of the patient-level and&#xD;
      institutional-level factors contributing to differences in therapeutic approach is needed in&#xD;
      order to improve the quality and consistency of care given to these high-risk patients. SAGE&#xD;
      is a multicenter, observational cohort study examining the patient-level and institutional&#xD;
      characteristics associated with variability in management of patients with moderate to severe&#xD;
      ARDS, factors associated with survival or need for adjuvant therapy, and variability in&#xD;
      ventilator management of patients on extracorporeal membrane oxygenation. Findings from this&#xD;
      observational study can subsequently be used to inform future interventional trial&#xD;
      development.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">April 30, 2017</completion_date>
  <primary_completion_date type="Actual">April 30, 2017</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>Hospital Mortality</measure>
    <time_frame>28 Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Use of Adjunctive Therapy</measure>
    <time_frame>28 Days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ventilator-Free Days</measure>
    <time_frame>28 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU-Free Days</measure>
    <time_frame>28 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ Failure</measure>
    <time_frame>7 Days</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2400</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <condition>Acute Respiratory Failure With Hypoxia</condition>
  <condition>Acute Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Moderate-Severe ARDS</arm_group_label>
    <description>All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 years&#xD;
&#xD;
          2. Patients with acute respiratory failure requiring invasive mechanical ventilation via&#xD;
             an endotracheal tube or tracheostomy with current or planned admission to the ICU&#xD;
&#xD;
          3. Moderate-severe ARDS as defined by fulfillment of all of the following within 48&#xD;
             hours:&#xD;
&#xD;
               1. Bilateral opacities detected on chest radiograph or CT, not fully explained by&#xD;
                  effusions, lung collapse, or nodules&#xD;
&#xD;
               2. Respiratory failure not fully explained by cardiac failure or fluid overload&#xD;
&#xD;
               3. PaO2/FiO2 ratio &lt; 150 with a minimum of 5 cmH20 PEEP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        There are no exclusion criteria.&#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>Nida Qadir, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pauline Park, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raquel Bartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michelle N Gong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles County + University of Southern California Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Medical Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Agnes Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Medical Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Ann Arbor</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regions Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregan Health and Science University Hospital</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 24, 2020</last_update_submitted>
  <last_update_submitted_qc>January 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Respiratory Distress Syndrome</keyword>
  <keyword>ARDS</keyword>
  <keyword>Acute Lung Injury</keyword>
  <keyword>ALI</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Extracorporeal Membrane Oxygenation</keyword>
  <keyword>Neuromuscular Blockade</keyword>
  <keyword>Vasodilator Agents</keyword>
  <keyword>Prone Position</keyword>
  <keyword>ECMO</keyword>
  <keyword>Acute Respiratory Failure</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>Respiratory Insufficiency</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03021824
org study id: 2016-6757
nct id: NCT03021824
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
An assessment of early management of moderate-severe ARDS in the United States, including
      ventilator management and use of rescue therapy.
Approximately one-quarter of ARDS patients develop severe hypoxemia, which has been
      associated with mortality rates approximating 40-50%. The majority have been described to
      present with severe disease at baseline, suggesting an opportunity for early intervention. In
      addition, use of evidence-based practices in severe ARDS is highly variable and inconsistent;
      use of unproven treatment modalities is also frequently seen. Given the variability in
      treatment practices in severe ARDS, an understanding of the patient-level and
      institutional-level factors contributing to differences in therapeutic approach is needed in
      order to improve the quality and consistency of care given to these high-risk patients. SAGE
      is a multicenter, observational cohort study examining the patient-level and institutional
      characteristics associated with variability in management of patients with moderate to severe
      ARDS, factors associated with survival or need for adjuvant therapy, and variability in
      ventilator management of patients on extracorporeal membrane oxygenation. Findings from this
      observational study can subsequently be used to inform future interventional trial
      development.
observational model: Cohort
time perspective: Other
measure: Hospital Mortality
time frame: 28 Days
measure: Use of Adjunctive Therapy
time frame: 28 Days
measure: Ventilator-Free Days
time frame: 28 Days
measure: ICU-Free Days
time frame: 28 Days
measure: Organ Failure
time frame: 7 Days
arm group label: Moderate-Severe ARDS
description: All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nida Qadir, MD
role: Principal Investigator
affiliation: Montefiore Medical Center
last name: Pauline Park, MD
role: Principal Investigator
affiliation: University of Michigan
last name: Raquel Bartz, MD
role: Principal Investigator
affiliation: Duke University
last name: Michelle N Gong, MD
role: Principal Investigator
affiliation: Montefiore Medical Center
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country: United States
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
mesh term: Acute Lung Injury
mesh term: Hypoxia
sharing ipd: Yes