<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/NCT03749525</url>
  </required_header>
  <id_info>
    <org_study_id>shenfu injection</org_study_id>
    <nct_id>NCT03749525</nct_id>
  </id_info>
  <brief_title>Shenfu Injection Improves Arterial Vascular Reactivity</brief_title>
  <official_title>Effect of Shenfu Injection on Arterial Vascular Reactivity in Patients With Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jianfeng Xie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</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>
      Septic shock is a common and critical illness in ICU.The vascular dysfunction of septic shock&#xD;
      is manifested by vasospasm and decreased arterial vascular reactivity . Current studies have&#xD;
      shown that the main mechanisms of vasospasm and decreased arterial vascular reactivity&#xD;
      include increased vasospasm and down-regulation of receptor sensitivity , and eventually&#xD;
      cause a decrease in vascular smooth muscle contractility.A large number of vasodilators are&#xD;
      released during septic shock, in which inducible nitric oxide synthase (iNOS) and&#xD;
      prostacyclin (PGI2) are important vasodilators leading to septic shock vasospasm.At present,&#xD;
      vasoactive drugs are widely used in clinically to improve vascular tone and are important&#xD;
      means of circulation support. However, when the infection is heavier, the reactivity of the&#xD;
      blood vessels to the vasoactive drugs is lowered, and it is difficult for the large doses of&#xD;
      the vasoactive drugs to maintain the circulation stability. At this time, the use of&#xD;
      vasoactive drugs alone does not benefit patients with septic shock and may require the&#xD;
      combination of other drugs.From the perspective of Chinese medicine, shock is a disease of&#xD;
      yang. Shenfu injection has the effect of rejuvenating the yang and replenishing the qi. This&#xD;
      trial was designed to give patients with septic shock the use of Shenfu injection to&#xD;
      determine the specific effects of Shenfu injection on vascular reactivity in patients with&#xD;
      septic shock.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of peripheral vascular resistance</measure>
    <time_frame>day 0(before shenfu injection is used), day 3 (after shenfu injection is used for 72 hours)</time_frame>
    <description>Peripheral vascular resistance will be measured by PiCCO or Swan-Ganz and the change between day 0 and day 3</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>day 1, day 2, day 3</time_frame>
    <description>We will measure blood pressure every hour and diastolic blood pressure will be recorded per hour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosage of vasoactive drugs</measure>
    <time_frame>day 1, day 2,day 3</time_frame>
    <description>dosages of noradrenaline, adrenaline or any other kinds of vasoactive drugs&#xD;
4/5000 dosages of adrenaline and norepinephrine</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Septic Shock</condition>
  <condition>Shenfu</condition>
  <condition>Vascular Reactivity</condition>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>5% GS solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>shenfu injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>shenfu injection</intervention_name>
    <description>we hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>placebo group</arm_group_label>
    <other_name>5% GS solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. diagnosed as septic shock according to 2016 SSC Guidelines;&#xD;
&#xD;
          2. The dose of norepinephrine required to maintain MAP&gt;65mmHg ≥0.5μg/kg.min;&#xD;
&#xD;
          3. SVRI &lt;800 dyns/cm5.m2;&#xD;
&#xD;
          4. CI&gt;2.5L/min/m2;&#xD;
&#xD;
          5. The patient or the patient's family signed the informed consent form for this trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. septic shock occurs more than 24 hours;&#xD;
&#xD;
          2. Age &gt; 85 years old or &lt;18 years old;&#xD;
&#xD;
          3. pregnant or lactating women;&#xD;
&#xD;
          4. There are shock patients caused by other causes such as cardiogenicity and&#xD;
             neurogenicity;&#xD;
&#xD;
          5. The terminal state of malignant tumor end-stage disease or the patient who is expected&#xD;
             to die within 24 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Han</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>haibo qin, professor</last_name>
    <role>Study Chair</role>
    <affiliation>southeast university zhongda hospitial</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>sun qin, doc</last_name>
    <phone>86-15952083606</phone>
    <email>sunqin1990@126.com</email>
  </overall_contact>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 9, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</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>physician, sponsor-investigator,clinical professor</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>
  <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/NCT03749525
org study id: shenfu injection
nct id: NCT03749525
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Septic shock is a common and critical illness in ICU.The vascular dysfunction of septic shock
      is manifested by vasospasm and decreased arterial vascular reactivity . Current studies have
      shown that the main mechanisms of vasospasm and decreased arterial vascular reactivity
      include increased vasospasm and down-regulation of receptor sensitivity , and eventually
      cause a decrease in vascular smooth muscle contractility.A large number of vasodilators are
      released during septic shock, in which inducible nitric oxide synthase (iNOS) and
      prostacyclin (PGI2) are important vasodilators leading to septic shock vasospasm.At present,
      vasoactive drugs are widely used in clinically to improve vascular tone and are important
      means of circulation support. However, when the infection is heavier, the reactivity of the
      blood vessels to the vasoactive drugs is lowered, and it is difficult for the large doses of
      the vasoactive drugs to maintain the circulation stability. At this time, the use of
      vasoactive drugs alone does not benefit patients with septic shock and may require the
      combination of other drugs.From the perspective of Chinese medicine, shock is a disease of
      yang. Shenfu injection has the effect of rejuvenating the yang and replenishing the qi. This
      trial was designed to give patients with septic shock the use of Shenfu injection to
      determine the specific effects of Shenfu injection on vascular reactivity in patients with
      septic shock.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The change of peripheral vascular resistance
time frame: day 0(before shenfu injection is used), day 3 (after shenfu injection is used for 72 hours)
description: Peripheral vascular resistance will be measured by PiCCO or Swan-Ganz and the change between day 0 and day 3
measure: Diastolic blood pressure
time frame: day 1, day 2, day 3
description: We will measure blood pressure every hour and diastolic blood pressure will be recorded per hour.
measure: Dosage of vasoactive drugs
time frame: day 1, day 2,day 3
description: dosages of noradrenaline, adrenaline or any other kinds of vasoactive drugs
4/5000 dosages of adrenaline and norepinephrine
arm group label: placebo group
arm group type: Placebo Comparator
description: 5% GS solution
arm group label: control group
arm group type: Active Comparator
description: shenfu injection
intervention type: Drug
intervention name: shenfu injection
description: we hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock
arm group label: control group
arm group label: placebo group
other name: 5% GS solution
criteria: 
gender: All
gender based: Yes
gender description: Han
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: haibo qin, professor
role: Study Chair
affiliation: southeast university zhongda hospitial
last name: sun qin, doc
phone: 86-15952083606
email: sunqin1990@126.com
responsible party type: Sponsor-Investigator
investigator affiliation: Southeast University, China
investigator full name: Jianfeng Xie
investigator title: physician, sponsor-investigator,clinical professor
mesh term: Shock, Septic
sharing ipd: Undecided