<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/NCT03238742</url>
  </required_header>
  <id_info>
    <org_study_id>2017ZDSYLL025-P01</org_study_id>
    <nct_id>NCT03238742</nct_id>
  </id_info>
  <brief_title>The Efficacy of Xuebijing Injection on Sepsis</brief_title>
  <official_title>The Efficacy of Xuebijing Injection in Adult Patients With Sepsis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Health and Family Planning Commission, P.R.China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      The Efficacy of Xuebijing Injection in Adult Patients with Sepsis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this placebo-controlled study is to determine if Xuebijing Injection treatment&#xD;
      provides significant mortality reduction improvement in patients with sepsis compared with&#xD;
      placebo treatment in patients receiving the current standard of care for sepsis. This study&#xD;
      will also assess the effectiveness of Xuebijing Injection in reducing 28-day mortality in&#xD;
      patients with sepsis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2017</start_date>
  <completion_date type="Actual">January 8, 2020</completion_date>
  <primary_completion_date type="Actual">July 28, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Blind (Participant, Investigator, Outcomes Assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>All-Cause Mortality</measure>
    <time_frame>28 Days after randomization</time_frame>
    <description>Death from all causes at 28-days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death in ICU</measure>
    <time_frame>28 Days after randomization</time_frame>
    <description>Death from all causes at ICU discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOFA score</measure>
    <time_frame>Day 0,3,6 after randomization</time_frame>
    <description>Total Sequential Organ Failure Assessment (SOFA) score(0-24) ，higher values represent a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APACHEⅡ</measure>
    <time_frame>Day 0,3,6 after randomization</time_frame>
    <description>Acute Physiology and Chronic Health Evaluation (include Acute physiology score, APS and age and Chronic physiology score, totally 0-71 Points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>28 days after randomization</time_frame>
    <description>Duration of mechanical ventilation in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>28 days after randomization</time_frame>
    <description>Duration of stay in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of C-reactive protein</measure>
    <time_frame>0,3,6days after randomization</time_frame>
    <description>C-reactive protein at 0, 3,6 days after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Procalcitonin</measure>
    <time_frame>0,3,6 days after randomization</time_frame>
    <description>Procalcitonin at 0,3,6days after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Human Leukocyte Antigen-DR</measure>
    <time_frame>0，6 days after randomization</time_frame>
    <description>Human Leukocyte Antigen-DR at 0, 6 days after randomization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1817</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100ml Xuebijing Injection will be dissolved in 100 mL of normal saline every 12 hours for 5 days in blind fashion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>normal saline 200 mL every 12 hours for 5 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xuebijing Injection</intervention_name>
    <description>100ml Xuebijing Injection every 12 hours for 5 days</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline</intervention_name>
    <description>200ml normal saline every 12 hours for 5 days</description>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>NS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients will be eligible for inclusion if all of the inclusion criteria are met&#xD;
&#xD;
          1. Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of&#xD;
             Intensive Care Medicine (ESICM)&#xD;
&#xD;
          2. 18≤ age ≤75years&#xD;
&#xD;
          3. 2 ≤SOFA ≤13&#xD;
&#xD;
          4. obtain informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of sepsis for more than 48 h;&#xD;
&#xD;
          2. Pregnant and lactating women;&#xD;
&#xD;
          3. Severe primary disease including unrespectable tumours, blood diseases and Human&#xD;
             Immunodeficiency Virus (HIV);&#xD;
&#xD;
          4. Severe liver and kidney dysfunction (single liver or kidney SOFA score ≥ 3 points);&#xD;
&#xD;
          5. Use of an immunosuppressant or having an organ transplant within the previous 6&#xD;
             months;&#xD;
&#xD;
          6. Participating in other clinical trials in the previous 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qiu Haibo, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southeast University</affiliation>
  </overall_official>
  <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>January 2021</verification_date>
  <study_first_submitted>July 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>January 1, 2021</last_update_submitted>
  <last_update_submitted_qc>January 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Songqiao Liu</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>Xuebijing Injection, morality, sepsis</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>Yes</sharing_ipd>
    <ipd_description>Mortality</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Study published</ipd_time_frame>
    <ipd_access_criteria>Supplyment</ipd_access_criteria>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>2</doc_id>
      <doc_type>Clinical Review&amp; Education</doc_type>
      <doc_url>http://www.ncbi.nlm.nih.gov/pubmed/26903338</doc_url>
      <doc_comment>Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC.The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315(8):801-10.</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03238742
org study id: 2017ZDSYLL025-P01
nct id: NCT03238742
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Efficacy of Xuebijing Injection in Adult Patients with Sepsis
The purpose of this placebo-controlled study is to determine if Xuebijing Injection treatment
      provides significant mortality reduction improvement in patients with sepsis compared with
      placebo treatment in patients receiving the current standard of care for sepsis. This study
      will also assess the effectiveness of Xuebijing Injection in reducing 28-day mortality in
      patients with sepsis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Blind (Participant, Investigator, Outcomes Assessor)
measure: All-Cause Mortality
time frame: 28 Days after randomization
description: Death from all causes at 28-days
measure: Death in ICU
time frame: 28 Days after randomization
description: Death from all causes at ICU discharge
measure: SOFA score
time frame: Day 0,3,6 after randomization
description: Total Sequential Organ Failure Assessment (SOFA) score(0-24) ，higher values represent a worse outcome
measure: APACHEⅡ
time frame: Day 0,3,6 after randomization
description: Acute Physiology and Chronic Health Evaluation (include Acute physiology score, APS and age and Chronic physiology score, totally 0-71 Points)
measure: Duration of mechanical ventilation
time frame: 28 days after randomization
description: Duration of mechanical ventilation in ICU
measure: ICU stay
time frame: 28 days after randomization
description: Duration of stay in ICU
measure: Concentration of C-reactive protein
time frame: 0,3,6days after randomization
description: C-reactive protein at 0, 3,6 days after randomization
measure: Concentration of Procalcitonin
time frame: 0,3,6 days after randomization
description: Procalcitonin at 0,3,6days after randomization
measure: Percentage of Human Leukocyte Antigen-DR
time frame: 0，6 days after randomization
description: Human Leukocyte Antigen-DR at 0, 6 days after randomization
arm group label: Intervention Group
arm group type: Experimental
description: 100ml Xuebijing Injection will be dissolved in 100 mL of normal saline every 12 hours for 5 days in blind fashion.
arm group label: Placebo group
arm group type: Placebo Comparator
description: normal saline 200 mL every 12 hours for 5 days
intervention type: Drug
intervention name: Xuebijing Injection
description: 100ml Xuebijing Injection every 12 hours for 5 days
arm group label: Intervention Group
intervention type: Drug
intervention name: normal saline
description: 200ml normal saline every 12 hours for 5 days
arm group label: Placebo group
other name: NS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Qiu Haibo, Dr.
role: Principal Investigator
affiliation: Southeast University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Songqiao Liu
investigator title: Principle investigator
mesh term: Sepsis
mesh term: Toxemia
sharing ipd: Yes
ipd description: Mortality
ipd info type: Study Protocol
ipd time frame: Study published
ipd access criteria: Supplyment
study doc: 