<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/NCT03227107</url>
  </required_header>
  <id_info>
    <org_study_id>81470266</org_study_id>
    <nct_id>NCT03227107</nct_id>
  </id_info>
  <brief_title>The Evaluation of NETs, Caspase-1 and Cytokines in ARDS Patients</brief_title>
  <official_title>IRF-1 Regulate Alveolar Macrophage Pyroptosis in Acute Lung Injury and of Which Will be Possible Mechanism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Natural Science Foundation of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xiangya Hospital of Central South University</source>
  <oversight_info>
    <has_dmc>No</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>
      1. enrollment criteria and clinical data collection: follow the principles of medical&#xD;
           ethics, the development of inclusion and exclusion criteria, select 90 cases of ARDS&#xD;
           patients, in the active treatment at the same time, according to the Berlin standard&#xD;
           severity of the disease divided into mild group, moderate Group and severe group,&#xD;
           according to the prognosis during hospitalization is divided into survival group and&#xD;
           death group. BALF specimens were collected on the day of admission to detect the levels&#xD;
           of NETs and alveolar macrophages. The acute and chronic health status scoring system Ⅱ&#xD;
           (APACHEⅡ) and Murray acute lung injury score, blood routine, creatinine, urea nitrogen,&#xD;
           fasting blood glucose, Item, mean arterial pressure, arterial blood gas analysis,&#xD;
           oxygenation index; record the patient's mechanical ventilation time and other data;&#xD;
&#xD;
        2. Pearson linear correlation analysis of BALF in the content of NETs, alveolar macrophage&#xD;
           coke death level was a positive correlation between the Spearman rank correlation&#xD;
           analysis BALF in the NETs content and alveolar macrophage coke death level, APACHE Ⅱ,&#xD;
           Murray score, creatinine, Urea nitrogen, fasting blood glucose and other indicators and&#xD;
           ARDS severity was positively correlated;&#xD;
&#xD;
        3. To analyze the prognostic factors of different prognostic factors, to evaluate the&#xD;
           content of NETs in BALF, the level of alveolar macrophage coke, APACHEⅡ and Murray&#xD;
           scores were analyzed by receiver operator characteristic curve (ROC curve) Short - term&#xD;
           survival outcome prognostic value.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>neutrophil extracellular traps, caspase-1,cytokines measurement</measure>
    <time_frame>4 years</time_frame>
    <description>Assessments with neutrophil extracellular traps be presented in ng/ml; Assessments with caspase-1 and cytokines be presented in pg/ml</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>ARDS</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with ARDS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ARDS patients diagnosis within 3 days&#xD;
&#xD;
          -  Over 18 years old but no more than 75 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe thoracic open trauma&#xD;
&#xD;
          -  Pulmonary embolism&#xD;
&#xD;
          -  Severe cardiovascular and cerebrovascular disease&#xD;
&#xD;
          -  Endocrine system diseases&#xD;
&#xD;
          -  Coagulation dysfunction&#xD;
&#xD;
          -  Liver and kidney failure&#xD;
&#xD;
          -  Malignant tumors&#xD;
&#xD;
          -  Cardiogenic pulmonary edema&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Li Haitao, Doctor</last_name>
    <phone>(+86)18684916132</phone>
    <email>168101013@csu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pan Pinhua, Doctor</last_name>
    <phone>(+86)13574810968</phone>
    <email>pinhuapan668@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xiangya hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Haitao, Doctor</last_name>
      <phone>(+86)18684916132</phone>
      <email>168101013@csu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xiangya Hospital of Central South University</investigator_affiliation>
    <investigator_full_name>panpinhua</investigator_full_name>
    <investigator_title>vice director of department of respiratory</investigator_title>
  </responsible_party>
  <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/NCT03227107
org study id: 81470266
nct id: NCT03227107
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. enrollment criteria and clinical data collection: follow the principles of medical
           ethics, the development of inclusion and exclusion criteria, select 90 cases of ARDS
           patients, in the active treatment at the same time, according to the Berlin standard
           severity of the disease divided into mild group, moderate Group and severe group,
           according to the prognosis during hospitalization is divided into survival group and
           death group. BALF specimens were collected on the day of admission to detect the levels
           of NETs and alveolar macrophages. The acute and chronic health status scoring system Ⅱ
           (APACHEⅡ) and Murray acute lung injury score, blood routine, creatinine, urea nitrogen,
           fasting blood glucose, Item, mean arterial pressure, arterial blood gas analysis,
           oxygenation index; record the patient's mechanical ventilation time and other data;

        2. Pearson linear correlation analysis of BALF in the content of NETs, alveolar macrophage
           coke death level was a positive correlation between the Spearman rank correlation
           analysis BALF in the NETs content and alveolar macrophage coke death level, APACHE Ⅱ,
           Murray score, creatinine, Urea nitrogen, fasting blood glucose and other indicators and
           ARDS severity was positively correlated;

        3. To analyze the prognostic factors of different prognostic factors, to evaluate the
           content of NETs in BALF, the level of alveolar macrophage coke, APACHEⅡ and Murray
           scores were analyzed by receiver operator characteristic curve (ROC curve) Short - term
           survival outcome prognostic value.
observational model: Cohort
time perspective: Prospective
measure: neutrophil extracellular traps, caspase-1,cytokines measurement
time frame: 4 years
description: Assessments with neutrophil extracellular traps be presented in ng/ml; Assessments with caspase-1 and cytokines be presented in pg/ml
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Li Haitao, Doctor
phone: (+86)18684916132
email: 168101013@csu.edu.cn
last name: Pan Pinhua, Doctor
phone: (+86)13574810968
email: pinhuapan668@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xiangya Hospital of Central South University
investigator full name: panpinhua
investigator title: vice director of department of respiratory
sharing ipd: Undecided