<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/NCT03821714</url>
  </required_header>
  <id_info>
    <org_study_id>2018ZDSYLL057-P01</org_study_id>
    <nct_id>NCT03821714</nct_id>
  </id_info>
  <brief_title>Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 on Microcirculation in Severe Septic Shock</brief_title>
  <official_title>Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 Versus Hydrocortisone Alone on Microcirculation in Severe Septic Shock</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>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>
      This study aimed to investigate the effect of Glucocorticoid combined with vitamin C and&#xD;
      vitamin B1 versus hydrocortisone alone on microcirculation in septic shock patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, double-blind, randomized, controlled trial enrolled septic shock patients&#xD;
      admitted to the intensive care unite of a tertiary teaching hospital. We randomly assigned&#xD;
      the enrolled patients to the treatment group (hydrocortisone combined with vitamin C and&#xD;
      vitamin B1 added to standard care) and the control group (hydrocortisone alone added to&#xD;
      standard care) in a 1:1 ratio. The primary outcome was perfusion vascular density (PVD) at 24&#xD;
      hours after treatment. We used the sublingual microcirculation imaging system to monitor PVD.&#xD;
      We further validated the primary outcome by observing differences in renal perfusion&#xD;
      monitored by renal contrast-enhanced ultrasound (CEUS) between the treatment group and the&#xD;
      control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <phase>N/A</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perfused vessel density (PVD)</measure>
    <time_frame>24 hours after treatment</time_frame>
    <description>Determinant of capillary diffusive capacity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>proportion of perfusion vessels</measure>
    <time_frame>24 hours after treatment</time_frame>
    <description>sublingual microcirculation parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total vascular density</measure>
    <time_frame>24 hours after treatment</time_frame>
    <description>sublingual microcirculation parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microvascular flow index</measure>
    <time_frame>24 hours after treatment</time_frame>
    <description>sublingual microcirculation parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>renal contrast-enhanced ultrasound parameters</measure>
    <time_frame>24 hours after treatment</time_frame>
    <description>renal perfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lactate</measure>
    <time_frame>24 hours after treatment</time_frame>
    <description>Tissue perfusion parameter</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Glucocorticoid combination therapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrocortisone 200mg continuous intravenous infusion(24h) combined with vitamin C1.5g intravenous infusion every 6 hours and vitamin B1 200mg intravenous infusion every 12 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucocorticoid Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hydrocortisone 200mg continuous intravenous infusion(24h)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glucocorticoid combination therapy</intervention_name>
    <description>Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.</description>
    <arm_group_label>Glucocorticoid combination therapy Group</arm_group_label>
    <other_name>Hydrocortisone, vitamin C and vitamin B1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glucocorticoid</intervention_name>
    <description>The glucocorticoid group was defined as the use of hydrocortisone alone.</description>
    <arm_group_label>Glucocorticoid Group</arm_group_label>
    <other_name>Hydrocortisone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Septic shock&#xD;
&#xD;
          2. A dose of norepinephrine (&gt;15ug/min)&#xD;
&#xD;
          3. Age ≥18 and ≤80 years old&#xD;
&#xD;
          4. Signing Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Meet the inclusion criteria for more than 12 hours&#xD;
&#xD;
          2. Clinician judges that corticosteroid therapy should not be used&#xD;
&#xD;
          3. Pregnant&#xD;
&#xD;
          4. Uncontrolled malignancy&#xD;
&#xD;
          5. Glucocorticoid therapy was used within seven days before admission.&#xD;
&#xD;
          6. Expected death within 24 hours&#xD;
&#xD;
          7. The sublingual microcirculation cannot be measured&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jingyuan Xu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southeast University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nanjing Zhongda Hospital, Southeast University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>May 25, 2021</last_update_submitted>
  <last_update_submitted_qc>May 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Jingyuan,Xu</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>septic shock</keyword>
  <keyword>glucocorticoid</keyword>
  <keyword>vitamin C</keyword>
  <keyword>microcirculation</keyword>
  <keyword>Vitamin B1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Hydrocortisone</mesh_term>
    <mesh_term>Hydrocortisone 17-butyrate 21-propionate</mesh_term>
    <mesh_term>Hydrocortisone acetate</mesh_term>
    <mesh_term>Hydrocortisone hemisuccinate</mesh_term>
    <mesh_term>Glucocorticoids</mesh_term>
  </intervention_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/NCT03821714
org study id: 2018ZDSYLL057-P01
nct id: NCT03821714
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aimed to investigate the effect of Glucocorticoid combined with vitamin C and
      vitamin B1 versus hydrocortisone alone on microcirculation in septic shock patients.
This prospective, double-blind, randomized, controlled trial enrolled septic shock patients
      admitted to the intensive care unite of a tertiary teaching hospital. We randomly assigned
      the enrolled patients to the treatment group (hydrocortisone combined with vitamin C and
      vitamin B1 added to standard care) and the control group (hydrocortisone alone added to
      standard care) in a 1:1 ratio. The primary outcome was perfusion vascular density (PVD) at 24
      hours after treatment. We used the sublingual microcirculation imaging system to monitor PVD.
      We further validated the primary outcome by observing differences in renal perfusion
      monitored by renal contrast-enhanced ultrasound (CEUS) between the treatment group and the
      control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Perfused vessel density (PVD)
time frame: 24 hours after treatment
description: Determinant of capillary diffusive capacity
measure: proportion of perfusion vessels
time frame: 24 hours after treatment
description: sublingual microcirculation parameter
measure: total vascular density
time frame: 24 hours after treatment
description: sublingual microcirculation parameter
measure: microvascular flow index
time frame: 24 hours after treatment
description: sublingual microcirculation parameter
measure: renal contrast-enhanced ultrasound parameters
time frame: 24 hours after treatment
description: renal perfusion
measure: lactate
time frame: 24 hours after treatment
description: Tissue perfusion parameter
arm group label: Glucocorticoid combination therapy Group
arm group type: Experimental
description: Hydrocortisone 200mg continuous intravenous infusion(24h) combined with vitamin C1.5g intravenous infusion every 6 hours and vitamin B1 200mg intravenous infusion every 12 hours.
arm group label: Glucocorticoid Group
arm group type: Active Comparator
description: Hydrocortisone 200mg continuous intravenous infusion(24h)
intervention type: Drug
intervention name: Glucocorticoid combination therapy
description: Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.
arm group label: Glucocorticoid combination therapy Group
other name: Hydrocortisone, vitamin C and vitamin B1
intervention type: Drug
intervention name: Glucocorticoid
description: The glucocorticoid group was defined as the use of hydrocortisone alone.
arm group label: Glucocorticoid Group
other name: Hydrocortisone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jingyuan Xu, PhD
role: Principal Investigator
affiliation: Southeast University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Jingyuan,Xu
investigator title: Clinical Professor
mesh term: Shock, Septic
mesh term: Shock
mesh term: Vitamins
mesh term: Hydrocortisone
mesh term: Hydrocortisone 17-butyrate 21-propionate
mesh term: Hydrocortisone acetate
mesh term: Hydrocortisone hemisuccinate
mesh term: Glucocorticoids
sharing ipd: No