<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/NCT03296761</url>
  </required_header>
  <id_info>
    <org_study_id>2017ZDSYLL081-P01</org_study_id>
    <nct_id>NCT03296761</nct_id>
  </id_info>
  <brief_title>Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury</brief_title>
  <official_title>Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jingyuan,Xu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To observe the changes of plasma ESM-1 levels in patients with ARDS, and to explore its&#xD;
      clinical significance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      70 patients who diagnosed as ARDS were included in this study. Then keep blood samples from&#xD;
      these patients in the first day, the third day and the seventh day, detect ESM-1 level in&#xD;
      plasma by ELISA. Record Severity of illness and survival status of every patient within 28&#xD;
      days. Objective to evaluate the correlation between the level of ESM-1 in plasma and the&#xD;
      prognosis of the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">February 20, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 20, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mortality</measure>
    <time_frame>28-day</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDS</condition>
  <arm_group>
    <arm_group_label>ESM-1&lt;5ng/ml</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ESM-1≥5ng/ml</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Population admitted to ICU of Zhongda hospital ，diagnosed of ARDS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients admitted to ICU diagnosed of ARDS (Berlin definition）in 48h&#xD;
&#xD;
          2. Patients age between 18 years old and 80 years.&#xD;
&#xD;
        Exclusion Criteria：&#xD;
&#xD;
          1. Pregnant women,&#xD;
&#xD;
          2. Patients with malignant tumor,&#xD;
&#xD;
          3. Immunosuppression or immunocompromised patients.&#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_official>
    <last_name>Haibo qiu</last_name>
    <role>Study Chair</role>
    <affiliation>Zhong-Da Hospital, School of Medicine, Southeast University,</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuanyuan YU</last_name>
    <phone>15651680953</phone>
    <email>220153911@seu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Haibo qiu</last_name>
    <phone>+862583262550</phone>
    <email>haiboq2000@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nanjing Zhongda Hospital, School of Medicine, Southeast University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuanyuan YU</last_name>
      <phone>15651680953</phone>
      <email>220153911@seu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 30, 2017</last_update_submitted>
  <last_update_submitted_qc>October 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Jingyuan,Xu</investigator_full_name>
    <investigator_title>chief doctor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03296761
org study id: 2017ZDSYLL081-P01
nct id: NCT03296761
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To observe the changes of plasma ESM-1 levels in patients with ARDS, and to explore its
      clinical significance.
70 patients who diagnosed as ARDS were included in this study. Then keep blood samples from
      these patients in the first day, the third day and the seventh day, detect ESM-1 level in
      plasma by ELISA. Record Severity of illness and survival status of every patient within 28
      days. Objective to evaluate the correlation between the level of ESM-1 in plasma and the
      prognosis of the patients.
observational model: Cohort
time perspective: Retrospective
measure: mortality
time frame: 28-day
arm group label: ESM-1<5ng/ml
arm group label: ESM-1≥5ng/ml
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Haibo qiu
role: Study Chair
affiliation: Zhong-Da Hospital, School of Medicine, Southeast University,
last name: Yuanyuan YU
phone: 15651680953
email: 220153911@seu.edu.cn
last name: Haibo qiu
phone: +862583262550
email: haiboq2000@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Southeast University, China
investigator full name: Jingyuan,Xu
investigator title: chief doctor
sharing ipd: No