<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/NCT04427371</url>
  </required_header>
  <id_info>
    <org_study_id>SoutheastUChina</org_study_id>
    <nct_id>NCT04427371</nct_id>
  </id_info>
  <brief_title>The Effect and Mechanism of lncRNA NBR2 Regulating Endothelial Pyroptosis by Targeting GSDMD in Sepsis</brief_title>
  <official_title>Zhongda Hospital, School of Medicine, Southeast University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jianfeng Xie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</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>
      Sepsis is a life-threatening disease characterized by multi-organ failure due to dysregulated&#xD;
      host response to infection, with high global mortality of 30-50%. One of the most important&#xD;
      pathophysiologic hallmarks in sepsis is vascular endothelial injury that contributes to the&#xD;
      severity and outcome of the syndrome. Effective treatments for endothelial cell injury in&#xD;
      sepsis have been lacking to improve prognosis. Endothelial pyroptosis is a vital mechanism of&#xD;
      vascular endothelial injury in sepsis; mitigation or abolishment of endothelial cell&#xD;
      pyroptosis alleviate vascular endothelial damage and improve the prognosis of sepsis mice.&#xD;
      Gasdermin D (GSDMD) mediated endothelial pyroptosis plays a critical role in modulating&#xD;
      vascular endothelial injury in sepsis.&#xD;
&#xD;
      Long non-coding RNA (lncRNA), as a class of non-coding protein RNA longer than 200 kD,&#xD;
      contributes to a variety of cell biological processes. The dysregulation of lncRNA results in&#xD;
      the occurrence and development of tumors, diabetes, sepsis and other diseases. Therefore, we&#xD;
      detected lncRNA and mRNA expression profile in 26 blood samples of septic patients using&#xD;
      Arraystar LncRNA Microarray. We found lncRNA NBR2 regulates septic endothelial pyroptosis.&#xD;
&#xD;
      To assess any correlation of pyroptosis levels with relevant endothelial cell injury&#xD;
      parameters and determine the prognostic value in septic patients. we measured the levels of&#xD;
      pyroptosis in patients admitted to the Department of Critical Care Medicine for sepsis and&#xD;
      investigated the correlation with related markers of endothelium injury. Furthermore, we&#xD;
      determined the prognostic value of pyroptosis levels for the mortality of patients with&#xD;
      sepsis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We measured the levels of pyroptosis in patients admitted to the Department of Critical Care&#xD;
      Medicine for sepsis and investigated the correlation with related markers of endothelium&#xD;
      injury. Furthermore, we determined the prognostic value of pyroptosis levels for the&#xD;
      mortality of patients with sepsis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 22, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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-day</time_frame>
    <description>all-cause 28-day mortality</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>survivors</arm_group_label>
    <description>Improve or under treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nonsurvivors</arm_group_label>
    <description>all-cause 28-day mortality</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>the levels of pyroptosis</intervention_name>
    <description>Blood samples were taken to detect plasma lncRNA NBR2 levels and GSDMD protein level.</description>
    <arm_group_label>nonsurvivors</arm_group_label>
    <arm_group_label>survivors</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        sepsis was defined according to &quot;sepsis 3.0&quot;, which including suspected or confirmed&#xD;
        infection and increased SOFA ≥ 2, confirmed by two experienced intensive care physicians.&#xD;
        The infection was defined on the basis of infection sites, clinical features, clinical&#xD;
        microbiology, and imaging tests. Septic shock was defined as a vasopressor requirement to&#xD;
        maintain a mean arterial pressure of 65 mmHg or greater and serum lactate level greater&#xD;
        than 2 mmol/L in the absence of hypovolemia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected or confirmed infection&#xD;
&#xD;
          -  The sequential organ failure score (SOFA score) increases by more than or equal to 2&#xD;
             points on the basis&#xD;
&#xD;
          -  Sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. the age &lt; 18 or &gt; 80 years of age&#xD;
&#xD;
          2. pregnant&#xD;
&#xD;
          3. tumor&#xD;
&#xD;
          4. viral hepatitis or liver cirrhosis&#xD;
&#xD;
          5. chronic renal tubular nephritis, chronic renal insufficiency&#xD;
&#xD;
          6. ulcerative colitis or crohn's disease&#xD;
&#xD;
          7. active systemic lupus erythematosus (SLE)&#xD;
&#xD;
          8. acute myocardial infarction&#xD;
&#xD;
          9. acute pancreatitis&#xD;
&#xD;
         10. engaged in other clinical subjects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fei Peng, Dr</last_name>
    <phone>025-83262553</phone>
    <email>afei0312@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yi Yang, Prof.</last_name>
    <phone>025-83262553</phone>
    <email>yiyiyang2004@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>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>Fei Peng, Dr</last_name>
      <phone>025-83262553</phone>
      <email>afei0312@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Jianfeng Xie</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>endothelial cell injury</keyword>
  <keyword>pyroptosis</keyword>
  <keyword>lncRNA NBR2</keyword>
  <keyword>gasdermin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
  </condition_browse>
  <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/NCT04427371
org study id: SoutheastUChina
nct id: NCT04427371
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Sepsis is a life-threatening disease characterized by multi-organ failure due to dysregulated
      host response to infection, with high global mortality of 30-50%. One of the most important
      pathophysiologic hallmarks in sepsis is vascular endothelial injury that contributes to the
      severity and outcome of the syndrome. Effective treatments for endothelial cell injury in
      sepsis have been lacking to improve prognosis. Endothelial pyroptosis is a vital mechanism of
      vascular endothelial injury in sepsis; mitigation or abolishment of endothelial cell
      pyroptosis alleviate vascular endothelial damage and improve the prognosis of sepsis mice.
      Gasdermin D (GSDMD) mediated endothelial pyroptosis plays a critical role in modulating
      vascular endothelial injury in sepsis.

      Long non-coding RNA (lncRNA), as a class of non-coding protein RNA longer than 200 kD,
      contributes to a variety of cell biological processes. The dysregulation of lncRNA results in
      the occurrence and development of tumors, diabetes, sepsis and other diseases. Therefore, we
      detected lncRNA and mRNA expression profile in 26 blood samples of septic patients using
      Arraystar LncRNA Microarray. We found lncRNA NBR2 regulates septic endothelial pyroptosis.

      To assess any correlation of pyroptosis levels with relevant endothelial cell injury
      parameters and determine the prognostic value in septic patients. we measured the levels of
      pyroptosis in patients admitted to the Department of Critical Care Medicine for sepsis and
      investigated the correlation with related markers of endothelium injury. Furthermore, we
      determined the prognostic value of pyroptosis levels for the mortality of patients with
      sepsis.
We measured the levels of pyroptosis in patients admitted to the Department of Critical Care
      Medicine for sepsis and investigated the correlation with related markers of endothelium
      injury. Furthermore, we determined the prognostic value of pyroptosis levels for the
      mortality of patients with sepsis.
observational model: Cohort
time perspective: Prospective
measure: 28-day mortality
time frame: 28-day
description: all-cause 28-day mortality
arm group label: survivors
description: Improve or under treatment
arm group label: nonsurvivors
description: all-cause 28-day mortality
intervention type: Other
intervention name: the levels of pyroptosis
description: Blood samples were taken to detect plasma lncRNA NBR2 levels and GSDMD protein level.
arm group label: nonsurvivors
arm group label: survivors
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fei Peng, Dr
phone: 025-83262553
email: afei0312@163.com
last name: Yi Yang, Prof.
phone: 025-83262553
email: yiyiyang2004@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Southeast University, China
investigator full name: Jianfeng Xie
investigator title: Dr.
mesh term: Sepsis
sharing ipd: No