<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/NCT02201446</url>
  </required_header>
  <id_info>
    <org_study_id>20131224</org_study_id>
    <nct_id>NCT02201446</nct_id>
  </id_info>
  <brief_title>The Role of Circulating Soluble CD74 in Acute Lung Injury</brief_title>
  <official_title>Relationship Between Elevated Soluble Cluster of Differentiation 74 (CD74) and Severity of Experimental and Clinical ALI/ARDS.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhai Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efforts to identify circulating factors that predict severity of acute lung injury/acute&#xD;
      respiratory distress syndrome（ALI/ARDS） patients is unrevealing. The primary purpose of this&#xD;
      study is to verify our hypothesis that soluble CD74 might be a potential novel ALI/ARDS&#xD;
      biomarker.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) is a devastating cause&#xD;
      of morbidity and mortality characterized by alveolar epithelial and endothelial injury.&#xD;
      Despite recent advances in pathogenetic mechanisms and therapy strategies of ALI, efforts to&#xD;
      identify circulating factors that predict severity of ALI/ARDS patients have been&#xD;
      unrevealing.&#xD;
&#xD;
      CD74 (also known as a major histocompatibility complex (MHC) class II invariant chain) is a&#xD;
      type II transmembrane protein, recently found to be the high-affinity receptor of macrophage&#xD;
      migration inhibitory factor (MIF). MIF promotes neutrophil accumulation in alveolar space via&#xD;
      binding to CD74 expressed on the cell surface. Our previous study， consistent with others,&#xD;
      has shown that MIF was highly expressed in acute lung injury (ALI). In addition, we also&#xD;
      detected highly CD74 expression in lipopolysaccharide (LPS)-induced ALI mouse model.&#xD;
      Recently, a circulating form of CD74 was discovered in autoimmune liver disease. Similarly,&#xD;
      we investigated the existence of soluble form of CD74 in serum and bronchoalveolar lavage&#xD;
      fluid (BALF) in ALI mouse model and burn or trauma related ALI patients. Based on these&#xD;
      finds, we postulated that soluble CD74 might participate in regulating lung inflammation and&#xD;
      be a potential novel ALI/ARDS biomarker.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Receiving Mechanical Ventilation</measure>
    <time_frame>up to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)</measure>
    <time_frame>up to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute Physiology and Chronic Health Evaluation (APACHE) II Scores</measure>
    <time_frame>up to 28 days</time_frame>
    <description>APACHE II scores range from 0 to 71. A higher values represent a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Soluble Cluster of Differentiations 74 (sCD74)</measure>
    <time_frame>Day 1</time_frame>
    <description>The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Soluble Cluster of Differentiations 74 (sCD74)</measure>
    <time_frame>Day 3</time_frame>
    <description>The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of Stay in the ICU</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of Unassisted Ventilation</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNF-α</measure>
    <time_frame>Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6</measure>
    <time_frame>Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MIF</measure>
    <time_frame>Day 3</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">139</enrollment>
  <condition>Acute Lung Injury</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>ARDS patients</arm_group_label>
    <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      ARDS patients and healthy volunteers&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with and without ARDS were screened from Changhai Hospital. Patients were enrolled&#xD;
        consecutively over a 2-year time period (2014-2015). All enrolled patients with ALI met the&#xD;
        American-European Consensus Committee criteria.In addition, healthy individuals were&#xD;
        recruited from the general population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of ALI/ARDS&#xD;
&#xD;
          -  Informed consent was obtained from either the subjects themselves or from designated&#xD;
             surrogates before enrollment in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have chronic lung disease before enrollment.&#xD;
&#xD;
          -  Patients who have severe organ dysfunction, autoimmune diseases and tumor.&#xD;
&#xD;
          -  Women who are pregnant or breast-feeding.&#xD;
&#xD;
          -  Patients who, in the opinion of the Investigator, have any other medical condition&#xD;
             which renders the patient unable to complete the study or which would interfere with&#xD;
             optimal participation in the study or produce significant risk to the patient.&#xD;
&#xD;
          -  Patients participating in or planning to enroll in another clinical trial during the&#xD;
             time of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhaofan Xia, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Burn Sugery, Changhai Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Burn and Trauma Sugery, Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Wu G, Sun Y, Wang K, Chen Z, Wang X, Chang F, Li T, Feng P, Xia Z. Relationship between elevated soluble CD74 and severity of experimental and clinical ALI/ARDS. Sci Rep. 2016 Jul 22;6:30067. doi: 10.1038/srep30067.</citation>
    <PMID>27444250</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <results_first_submitted>July 28, 2015</results_first_submitted>
  <results_first_submitted_qc>October 23, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 15, 2016</results_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Zhaofan Xia</investigator_full_name>
    <investigator_title>President</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>Acute Lung Injury</mesh_term>
    <mesh_term>Lung Injury</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ARDS Patients</title>
          <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
        </group>
        <group group_id="P2">
          <title>Healthy Volunteers</title>
          <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ARDS Patients</title>
          <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
        </group>
        <group group_id="B2">
          <title>Healthy Volunteers</title>
          <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="81"/>
            <count group_id="B2" value="58"/>
            <count group_id="B3" value="139"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>The age of participant.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.02" spread="16.05"/>
                    <measurement group_id="B2" value="39.52" spread="10.43"/>
                    <measurement group_id="B3" value="44.47" spread="14.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sequential Organ Failure Assessment(SOFA)</title>
          <description>SOFA score ranges from 0 to 43. A higher values represent a worse outcome.</description>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.16" spread="3.70"/>
                    <measurement group_id="B2" value="NA" spread="NA">Not collected for healthy volunteers</measurement>
                    <measurement group_id="B3" value="7.16" spread="3.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Trauma</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Inhalation injury</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes mellitus</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Kidney disease</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Respiratory disease</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood diseases</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Day1 tumor necrosis factor-α(TNF-α)</title>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97.09" lower_limit="92.32" upper_limit="100.82"/>
                    <measurement group_id="B2" value="NA" lower_limit="NA" upper_limit="NA">not collected for healthy volunteers</measurement>
                    <measurement group_id="B3" value="97.09" lower_limit="92.32" upper_limit="100.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Day1 interleukin-6 (IL-6)</title>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101.63" lower_limit="79.5" upper_limit="138.9"/>
                    <measurement group_id="B2" value="NA" lower_limit="NA" upper_limit="NA">not collected for healthy volunteers</measurement>
                    <measurement group_id="B3" value="101.63" lower_limit="79.5" upper_limit="138.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Day1 migration inhibitory factor (MIF)</title>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.64" spread="23.27"/>
                    <measurement group_id="B2" value="NA" spread="NA">not collected for healthy volunteers</measurement>
                    <measurement group_id="B3" value="73.64" spread="23.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Receiving Mechanical Ventilation</title>
        <time_frame>up to 28 days</time_frame>
        <population>not collected for healthy volunteers</population>
        <group_list>
          <group group_id="O1">
            <title>ARDS Patients</title>
            <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Receiving Mechanical Ventilation</title>
          <population>not collected for healthy volunteers</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="NA">not collected for healthy volunteers</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)</title>
        <time_frame>up to 28 days</time_frame>
        <population>not collected for healthy volunteers</population>
        <group_list>
          <group group_id="O1">
            <title>ARDS Patients</title>
            <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)</title>
          <population>not collected for healthy volunteers</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="0.46"/>
                    <measurement group_id="O2" value="NA" spread="NA">not collected for healthy volunteers</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acute Physiology and Chronic Health Evaluation (APACHE) II Scores</title>
        <description>APACHE II scores range from 0 to 71. A higher values represent a worse outcome.</description>
        <time_frame>up to 28 days</time_frame>
        <population>not collected for healthy volunteers</population>
        <group_list>
          <group group_id="O1">
            <title>ARDS Patients</title>
            <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Physiology and Chronic Health Evaluation (APACHE) II Scores</title>
          <description>APACHE II scores range from 0 to 71. A higher values represent a worse outcome.</description>
          <population>not collected for healthy volunteers</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.35" spread="6.39"/>
                    <measurement group_id="O2" value="NA" spread="NA">not collected for healthy volunteers</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Serum Soluble Cluster of Differentiations 74 (sCD74)</title>
        <description>The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARDS Patients</title>
            <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Soluble Cluster of Differentiations 74 (sCD74)</title>
          <description>The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.</description>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.04" spread="31.53"/>
                    <measurement group_id="O2" value="-14.77" spread="15.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Serum Soluble Cluster of Differentiations 74 (sCD74)</title>
        <description>The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.</description>
        <time_frame>Day 3</time_frame>
        <population>Only 62 ARDS patients with Day 3 blood samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>ARDS Patients</title>
            <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Soluble Cluster of Differentiations 74 (sCD74)</title>
          <description>The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.</description>
          <population>Only 62 ARDS patients with Day 3 blood samples were analyzed.</population>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132.92" spread="40.40"/>
                    <measurement group_id="O2" value="-14.78" spread="15.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay in the ICU</title>
        <time_frame>1 year</time_frame>
        <population>not collected for healthy volunteers</population>
        <group_list>
          <group group_id="O1">
            <title>ARDS Patients</title>
            <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay in the ICU</title>
          <population>not collected for healthy volunteers</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" lower_limit="15" upper_limit="44"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">not collected for healthy volunteers</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay</title>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARDS Patients</title>
            <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.94" lower_limit="22" upper_limit="53"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">not collected for healthy volunteers</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days of Unassisted Ventilation</title>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARDS Patients</title>
            <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Days of Unassisted Ventilation</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" lower_limit="8.5" upper_limit="28"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">not collected for healthy volunteers</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Death</title>
        <time_frame>up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARDS Patients</title>
            <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Death</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TNF-α</title>
        <time_frame>Day 3</time_frame>
        <population>Only 62 ARDS patients with Day 3 blood samples were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>ARDS Patients</title>
            <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
          </group>
        </group_list>
        <measure>
          <title>TNF-α</title>
          <population>Only 62 ARDS patients with Day 3 blood samples were analyzed</population>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138.67" spread="64.26"/>
                    <measurement group_id="O2" value="NA" spread="NA">not collected for healthy volunteers</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IL-6</title>
        <time_frame>Day 3</time_frame>
        <population>Only 62 ARDS patients with Day 3 blood samples were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>ARDS Patients</title>
            <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
          </group>
        </group_list>
        <measure>
          <title>IL-6</title>
          <population>Only 62 ARDS patients with Day 3 blood samples were analyzed</population>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="305.36" spread="177.14"/>
                    <measurement group_id="O2" value="NA" spread="NA">not collected for healthy volunteers</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MIF</title>
        <time_frame>Day 3</time_frame>
        <population>Only 62 ARDS patients with Day 3 blood samples were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>ARDS Patients</title>
            <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
          </group>
        </group_list>
        <measure>
          <title>MIF</title>
          <population>Only 62 ARDS patients with Day 3 blood samples were analyzed</population>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129.27" spread="41.12"/>
                    <measurement group_id="O2" value="NA" spread="NA">not collected for healthy volunteers</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ARDS Patients</title>
          <description>Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.</description>
        </group>
        <group group_id="E2">
          <title>Healthy Volunteers</title>
          <description>Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Heart failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Respiratory infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal inadequacy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Astriction or diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety or depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Guo-sheng Wu</name_or_title>
      <organization>Department of Burn Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, People's Republic of China</organization>
      <phone>+86 18019359841</phone>
      <email>drwuguosheng@sina.cn</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02201446
org study id: 20131224
nct id: NCT02201446
lead sponsor: 
has dmc: No
Efforts to identify circulating factors that predict severity of acute lung injury/acute
      respiratory distress syndrome（ALI/ARDS） patients is unrevealing. The primary purpose of this
      study is to verify our hypothesis that soluble CD74 might be a potential novel ALI/ARDS
      biomarker.
Acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) is a devastating cause
      of morbidity and mortality characterized by alveolar epithelial and endothelial injury.
      Despite recent advances in pathogenetic mechanisms and therapy strategies of ALI, efforts to
      identify circulating factors that predict severity of ALI/ARDS patients have been
      unrevealing.

      CD74 (also known as a major histocompatibility complex (MHC) class II invariant chain) is a
      type II transmembrane protein, recently found to be the high-affinity receptor of macrophage
      migration inhibitory factor (MIF). MIF promotes neutrophil accumulation in alveolar space via
      binding to CD74 expressed on the cell surface. Our previous study， consistent with others,
      has shown that MIF was highly expressed in acute lung injury (ALI). In addition, we also
      detected highly CD74 expression in lipopolysaccharide (LPS)-induced ALI mouse model.
      Recently, a circulating form of CD74 was discovered in autoimmune liver disease. Similarly,
      we investigated the existence of soluble form of CD74 in serum and bronchoalveolar lavage
      fluid (BALF) in ALI mouse model and burn or trauma related ALI patients. Based on these
      finds, we postulated that soluble CD74 might participate in regulating lung inflammation and
      be a potential novel ALI/ARDS biomarker.
observational model: Case-Control
time perspective: Prospective
measure: Number of Participants Receiving Mechanical Ventilation
time frame: up to 28 days
measure: Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)
time frame: up to 28 days
measure: Acute Physiology and Chronic Health Evaluation (APACHE) II Scores
time frame: up to 28 days
description: APACHE II scores range from 0 to 71. A higher values represent a worse outcome.
measure: Serum Soluble Cluster of Differentiations 74 (sCD74)
time frame: Day 1
description: The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.
measure: Serum Soluble Cluster of Differentiations 74 (sCD74)
time frame: Day 3
description: The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.
measure: Length of Stay in the ICU
time frame: 1 year
measure: Length of Hospital Stay
time frame: 1 year
measure: Days of Unassisted Ventilation
time frame: 1 year
measure: Death
time frame: up to 28 days
measure: TNF-α
time frame: Day 3
measure: IL-6
time frame: Day 3
measure: MIF
time frame: Day 3
arm group label: ARDS patients
description: Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
arm group label: Healthy volunteers
description: Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
ARDS patients and healthy volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zhaofan Xia, MD PhD
role: Study Director
affiliation: Department of Burn Sugery, Changhai Hospital
facility: 
country: China
citation: Wu G, Sun Y, Wang K, Chen Z, Wang X, Chang F, Li T, Feng P, Xia Z. Relationship between elevated soluble CD74 and severity of experimental and clinical ALI/ARDS. Sci Rep. 2016 Jul 22;6:30067. doi: 10.1038/srep30067.
PMID: 27444250
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: Zhaofan Xia
investigator title: President
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Lung Injury
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 