<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/NCT03289312</url>
  </required_header>
  <id_info>
    <org_study_id>2017ZDSYSLLoss</org_study_id>
    <nct_id>NCT03289312</nct_id>
  </id_info>
  <brief_title>Dissecting How Peripheral Lymphocytes Are Lost During Sepsis</brief_title>
  <acronym>SLL</acronym>
  <official_title>Dissecting How Peripheral Lymphocytes Are Lost During Sepsis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</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>
      There is an observational, clinical study. We recruit sepsis patients to investigate what&#xD;
      drives peripheral lymphocyte loss in sepsis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is an observational, clinical study. We recruit patients with diagnosis of new onset&#xD;
      sepsis within 24h, collect and record clinical characteristics：&#xD;
&#xD;
      ①Demography data，diagnosis, admission source, infection source, APACHE II,SOFA&#xD;
      scores;②Endotoxin levels and PaO2 measured;③Immune and systemic inflammatory indicators：T,&#xD;
      RR, WBC, ALC, etc.;④Complicated organs dysfunctions: duration and therapy;⑤Incidence of&#xD;
      ICU-acquired infection and prognosis.The blood samples were collected for&#xD;
      apoptosis,necrosis,autophagy,pyroptosis measurements.The aim of this study is to investigate&#xD;
      how peripheal lymphocyte loss relates to outcome and the mechanisms of peripheal lymphocyte&#xD;
      loss in different condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 11, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>lymphocyte loss</measure>
    <time_frame>day of inclussion and 7th day after inclussion</time_frame>
    <description>ratios of T cells loss by different mechanism in different subgroups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prognosis</measure>
    <time_frame>28-day after inclussion</time_frame>
    <description>28-day prognosis:survive or not</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complicated organ dysfunction</measure>
    <time_frame>during 28 days after inclussion</time_frame>
    <description>duration and surpport therapy</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Sepsis</arm_group_label>
    <description>Diagnosis of new onset sepsis within 24h without history of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health control</arm_group_label>
    <description>Health vonlunteers</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of new onset sepsis within 24h.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of tumor, hematological or immunological disease, and treatment with&#xD;
             chemotherapy agents or corticosteroids within 6 months prior to or during the&#xD;
             hospitalization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of tumor, hematological or immunological disease, and treatment with&#xD;
             chemotherapy agents or corticosteroids within 6 months prior to or during the&#xD;
             hospitalization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ming Xue, MD</last_name>
    <phone>08615195971003</phone>
    <email>xueming0304@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongda Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>December 26, 2017</last_update_submitted>
  <last_update_submitted_qc>December 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Jianfeng Xie</investigator_full_name>
    <investigator_title>Southeast University, China</investigator_title>
  </responsible_party>
  <keyword>sepsis, lymphocyte</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>
  <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/NCT03289312
org study id: 2017ZDSYSLLoss
nct id: NCT03289312
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is an observational, clinical study. We recruit sepsis patients to investigate what
      drives peripheral lymphocyte loss in sepsis.
There is an observational, clinical study. We recruit patients with diagnosis of new onset
      sepsis within 24h, collect and record clinical characteristics：

      ①Demography data，diagnosis, admission source, infection source, APACHE II,SOFA
      scores;②Endotoxin levels and PaO2 measured;③Immune and systemic inflammatory indicators：T,
      RR, WBC, ALC, etc.;④Complicated organs dysfunctions: duration and therapy;⑤Incidence of
      ICU-acquired infection and prognosis.The blood samples were collected for
      apoptosis,necrosis,autophagy,pyroptosis measurements.The aim of this study is to investigate
      how peripheal lymphocyte loss relates to outcome and the mechanisms of peripheal lymphocyte
      loss in different condition.
observational model: Case-Control
time perspective: Prospective
measure: lymphocyte loss
time frame: day of inclussion and 7th day after inclussion
description: ratios of T cells loss by different mechanism in different subgroups
measure: prognosis
time frame: 28-day after inclussion
description: 28-day prognosis:survive or not
measure: Complicated organ dysfunction
time frame: during 28 days after inclussion
description: duration and surpport therapy
arm group label: Sepsis
description: Diagnosis of new onset sepsis within 24h without history of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.
arm group label: Health control
description: Health vonlunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ming Xue, MD
phone: 08615195971003
email: xueming0304@126.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Jianfeng Xie
investigator title: Southeast University, China
mesh term: Sepsis
mesh term: Toxemia
sharing ipd: Undecided