<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/NCT03253146</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH ZS1080</org_study_id>
    <nct_id>NCT03253146</nct_id>
  </id_info>
  <brief_title>The Role and Mechanism of Vimentin in Sepsis Patients</brief_title>
  <official_title>The Role and Mechanism of Vimentin in Sepsis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      Sepsis is the most common cause of death in the clinical critically ill patients. We have&#xD;
      successfully screened the sepsis biomarkers by clinical proteomics approach and found that&#xD;
      Vimentin (VIM) played an important role in the occurrence and development of sepsis. However,&#xD;
      the exact mechanism is remaining unclear. In this study, the relationship between the changes&#xD;
      of peripheral circulation VIM expression and different stages of sepsis development will be&#xD;
      further verified in lager clinical trials, as well as the relationship between VIM expression&#xD;
      and apoptosis of immune cells (e.g lymphocytes) will also be clarified. This may indicate&#xD;
      that the role of VIM in the cell-mediated immunity apoptosis and inflammation-related&#xD;
      pathways. Through the implementation of this study, we can clarify the clinical value of VIM&#xD;
      and the mechanism of VIM-mediated immune cell apoptosis during the sepsis development from&#xD;
      the molecular level, and determine whether the VIM as a new target for sepsis diagnosis and&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>28-day survival</measure>
    <time_frame>28-day</time_frame>
    <description>The survival time of patients more than 28days is defined as survival. The survival time of patients less than 28days is defined as death.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>sepsis</arm_group_label>
    <description>Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.&#xD;
Organ dysfunction can be identified as an acute change in total SOFA score ≥2 points consequent to the infection.&#xD;
The baseline SOFA score can be assumed to be zero in patients not known to have preexisting organ dysfunction.&#xD;
ASOFA score ≥2 reflects an overall mortality risk of approximately 10% in a general hospital population with suspected infection. Even patients presenting with modest dysfunction can deteriorate further, emphasizing the seriousness of this condition and the need for prompt and appropriate intervention, if not already being instituted.&#xD;
In lay terms, sepsis is a life-threatening condition that arises when the body's response to an infection injures its own tissues and organs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>septic shock</arm_group_label>
    <description>Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level &gt;2 mmol/L (18mg/dL) despite adequate volume resuscitation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>VIM detection</intervention_name>
    <description>VIM expression in serum and lymphocytes detection</description>
    <arm_group_label>sepsis</arm_group_label>
    <arm_group_label>septic shock</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Within 24 h (the first day of study) after ICU admission, blood samples was collected.Blood&#xD;
      was centrifuged at 3,000 rpm for 15 minutes. The supernatants were transferred to Eppendorf&#xD;
      tubes and stored at -80°C.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Between july 2016 and december 2017, inpatients were included who were in the Department of&#xD;
        critical care medicine of the Peking Union Medical College Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Sepsis 3.0 was adopted to selected participants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants were excluded if they were younger than 18 years of age; contracted acquired&#xD;
        immunodeficiency syndrome; had reduced polymorphonuclear granulocyte counts (&lt;500 μL-1);&#xD;
        died within 24 h after admission to the ICU; refused to participate in the study; or&#xD;
        declined treatment during the period of observation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Dawei Liu, MD</last_name>
    <phone>+86 10 69152305</phone>
    <email>dwliu98@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Longxiang Su, MD</last_name>
    <phone>+86 10 69152300</phone>
    <email>slx77@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dawei Liu, MD</last_name>
      <phone>+86 10 69152305</phone>
      <email>dwliu98@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vimentin</keyword>
  <keyword>sepsis</keyword>
  <keyword>immune cells</keyword>
  <keyword>apoptosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03253146
org study id: PUMCH ZS1080
nct id: NCT03253146
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sepsis is the most common cause of death in the clinical critically ill patients. We have
      successfully screened the sepsis biomarkers by clinical proteomics approach and found that
      Vimentin (VIM) played an important role in the occurrence and development of sepsis. However,
      the exact mechanism is remaining unclear. In this study, the relationship between the changes
      of peripheral circulation VIM expression and different stages of sepsis development will be
      further verified in lager clinical trials, as well as the relationship between VIM expression
      and apoptosis of immune cells (e.g lymphocytes) will also be clarified. This may indicate
      that the role of VIM in the cell-mediated immunity apoptosis and inflammation-related
      pathways. Through the implementation of this study, we can clarify the clinical value of VIM
      and the mechanism of VIM-mediated immune cell apoptosis during the sepsis development from
      the molecular level, and determine whether the VIM as a new target for sepsis diagnosis and
      treatment.
observational model: Case-Only
time perspective: Prospective
measure: 28-day survival
time frame: 28-day
description: The survival time of patients more than 28days is defined as survival. The survival time of patients less than 28days is defined as death.
arm group label: sepsis
description: Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
Organ dysfunction can be identified as an acute change in total SOFA score ≥2 points consequent to the infection.
The baseline SOFA score can be assumed to be zero in patients not known to have preexisting organ dysfunction.
ASOFA score ≥2 reflects an overall mortality risk of approximately 10% in a general hospital population with suspected infection. Even patients presenting with modest dysfunction can deteriorate further, emphasizing the seriousness of this condition and the need for prompt and appropriate intervention, if not already being instituted.
In lay terms, sepsis is a life-threatening condition that arises when the body's response to an infection injures its own tissues and organs.
arm group label: septic shock
description: Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L (18mg/dL) despite adequate volume resuscitation.
intervention type: Diagnostic Test
intervention name: VIM detection
description: VIM expression in serum and lymphocytes detection
arm group label: sepsis
arm group label: septic shock
Within 24 h (the first day of study) after ICU admission, blood samples was collected.Blood
      was centrifuged at 3,000 rpm for 15 minutes. The supernatants were transferred to Eppendorf
      tubes and stored at -80°C.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Dawei Liu, MD
phone: +86 10 69152305
email: dwliu98@126.com
last name: Longxiang Su, MD
phone: +86 10 69152300
email: slx77@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Toxemia