xml: <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/NCT06013033</url>
    </required_header>
    <id_info>
      <org_study_id>82202393</org_study_id>
      <nct_id>NCT06013033</nct_id>
    </id_info>
    <brief_title>DDX17 Orchestrate Septic Vascular Endothelial Pyroptosis by Controlling Gasdermin D Pore Formation</brief_title>
    <official_title>DDX17 Orchestrate Septic Vascular Endothelial Pyroptosis by Controlling Gasdermin D Pore Formation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongda Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongda Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Objective: To investigate the correlation between plasma levels of DDX17 and GSDMD with&#xD;
        vascular endothelial dysfunction and prognosis of in sepsis patients.&#xD;
  &#xD;
        Design: A single center, prospective, observational research. Participants: Patients with&#xD;
        sepsis who are hospitalized to Southeast University Affiliated Zhongda Hospital and meet the&#xD;
        diagnostic criteria for sepsis 3.0.&#xD;
  &#xD;
        Inclusion criteria:1. There is a potential or clear infection; 2. Sequential organ failure&#xD;
        score (SOFA score) increases by more than or equal to 2 points compared to the baseline&#xD;
        value; 3. Sign informed consent form.&#xD;
  &#xD;
        Exclusion criteria: Age&lt;18 years old or&gt;80 years old, pregnant women, tumor patients,&#xD;
        including diseases that may be complicated with vascular endothelial damage: hypertension,&#xD;
        acute and chronic hepatitis (hepatitis caused by virus), liver cirrhosis, PT prolongation&#xD;
        after liver transplantation, acute myocardial infarction, chronic tubular nephritis, chronic&#xD;
        renal insufficiency/maintenance hemodialysis, renal transplantation, interstitial pneumonia,&#xD;
        acute pancreatitis, active phase of systemic lupus erythematosus Ulcerative colitis, Crohn's&#xD;
        disease, HELLP syndrome.&#xD;
  &#xD;
        Primary outcome: 28-day mortality. Secondary outcome: Plasma levels of DDX17 and GSDMD, and&#xD;
        their correlation with vascular endothelial injury, severity, and prognosis in sepsis&#xD;
        patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Data collection:Recording the population information, including name, sex, BMI, and past&#xD;
        history. Recording disease-related information's, including diagnosis, infection site,&#xD;
        pathogens, organ dysfunction, SOFA and APACHE II scores. Recording treatment measures of&#xD;
        patients, including whether to use vasopressor, invasive mechanical ventilation, and&#xD;
        continuous renal replacement therapy. Recording laboratory examination results, including&#xD;
        leukocyte count, PCT and hs-CRP on D1, D3 and D7, respectively. All patients were followed up&#xD;
        to 28 days. Patients were distributed to survival group and non-survival group according to&#xD;
        the 28-day survival.&#xD;
  &#xD;
        Sample collection: 3 mL of the patient's peripheral blood were drawn on Day1, 3, and 7, and&#xD;
        the plasma was centrifuged and kept at -80 °C. ELISA content detection of DDX17 and GSDMD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>28-day mortality</measure>
      <time_frame>28 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>correlation between plasma level of DDX17 and vascular endothelial injury, severity, and prognosis in sepsis patients</measure>
      <time_frame>28 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>correlation between plasma level of GSDMD and vascular endothelial injury, severity, and prognosis in sepsis patients</measure>
      <time_frame>28 days</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Sepsis</condition>
    <condition>Septic Shock</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        3 mL of the patient's peripheral blood were drawn on Day1, 3, and 7, and the plasma was&#xD;
        centrifuged and kept at -80 °C. ELISA content detection of DDX17 and GSDMD.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with sepsis who are hospitalized to Southeast University Affiliated Zhongda&#xD;
          Hospital and meet the diagnostic criteria for sepsis 3.0.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  There is a potential or clear infection;&#xD;
  &#xD;
            -  Sequential organ failure score (SOFA score) increases by more than or equal to 2&#xD;
               points compared to the baseline value;&#xD;
  &#xD;
            -  Sign informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age&lt;18 years old or&gt;80 years old&#xD;
  &#xD;
            -  pregnant women&#xD;
  &#xD;
            -  tumor patients&#xD;
  &#xD;
            -  including diseases that may be complicated with vascular endothelial damage:&#xD;
               hypertension, acute and chronic hepatitis (hepatitis caused by virus), liver&#xD;
               cirrhosis, PT prolongation after liver transplantation, acute myocardial infarction,&#xD;
               chronic tubular nephritis, chronic renal insufficiency/maintenance hemodialysis, renal&#xD;
               transplantation, interstitial pneumonia, acute pancreatitis, active phase of systemic&#xD;
               lupus erythematosus Ulcerative colitis, Crohn's disease, HELLP syndrome.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhongda Hospital</investigator_affiliation>
      <investigator_full_name>Fei Peng</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Shock, Septic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013033
  org study id: 82202393
  nct id: NCT06013033
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Objective: To investigate the correlation between plasma levels of DDX17 and GSDMD with
        vascular endothelial dysfunction and prognosis of in sepsis patients.
  
        Design: A single center, prospective, observational research. Participants: Patients with
        sepsis who are hospitalized to Southeast University Affiliated Zhongda Hospital and meet the
        diagnostic criteria for sepsis 3.0.
  
        Inclusion criteria:1. There is a potential or clear infection; 2. Sequential organ failure
        score (SOFA score) increases by more than or equal to 2 points compared to the baseline
        value; 3. Sign informed consent form.
  
        Exclusion criteria: Age<18 years old or>80 years old, pregnant women, tumor patients,
        including diseases that may be complicated with vascular endothelial damage: hypertension,
        acute and chronic hepatitis (hepatitis caused by virus), liver cirrhosis, PT prolongation
        after liver transplantation, acute myocardial infarction, chronic tubular nephritis, chronic
        renal insufficiency/maintenance hemodialysis, renal transplantation, interstitial pneumonia,
        acute pancreatitis, active phase of systemic lupus erythematosus Ulcerative colitis, Crohn's
        disease, HELLP syndrome.
  
        Primary outcome: 28-day mortality. Secondary outcome: Plasma levels of DDX17 and GSDMD, and
        their correlation with vascular endothelial injury, severity, and prognosis in sepsis
        patients.
  Data collection:Recording the population information, including name, sex, BMI, and past
        history. Recording disease-related information's, including diagnosis, infection site,
        pathogens, organ dysfunction, SOFA and APACHE II scores. Recording treatment measures of
        patients, including whether to use vasopressor, invasive mechanical ventilation, and
        continuous renal replacement therapy. Recording laboratory examination results, including
        leukocyte count, PCT and hs-CRP on D1, D3 and D7, respectively. All patients were followed up
        to 28 days. Patients were distributed to survival group and non-survival group according to
        the 28-day survival.
  
        Sample collection: 3 mL of the patient's peripheral blood were drawn on Day1, 3, and 7, and
        the plasma was centrifuged and kept at -80 °C. ELISA content detection of DDX17 and GSDMD.
  observational model: Cohort
  time perspective: Prospective
  measure: 28-day mortality
  time frame: 28 days
  measure: correlation between plasma level of DDX17 and vascular endothelial injury, severity, and prognosis in sepsis patients
  time frame: 28 days
  measure: correlation between plasma level of GSDMD and vascular endothelial injury, severity, and prognosis in sepsis patients
  time frame: 28 days
  3 mL of the patient's peripheral blood were drawn on Day1, 3, and 7, and the plasma was
        centrifuged and kept at -80 °C. ELISA content detection of DDX17 and GSDMD.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Zhongda Hospital
  investigator full name: Fei Peng
  investigator title: Principal Investigator
  mesh term: Shock, Septic