<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/NCT03835286</url>
  </required_header>
  <id_info>
    <org_study_id>EHE0042</org_study_id>
    <nct_id>NCT03835286</nct_id>
  </id_info>
  <brief_title>Vitamin C to Reduce Vasopressor Dose in Septic Shock</brief_title>
  <acronym>ViCiS</acronym>
  <official_title>Vitamin C to Reduce Exogenous Vasopressor Dose in Septic Shock; a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Español de Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Español de Mexico</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>
      Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of&#xD;
      the Hospital Español de México with a diagnosis of septic shock will be included.&#xD;
&#xD;
      Patients will be randomized to one of the study groups:&#xD;
&#xD;
      Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in&#xD;
      continuous infusion for 72 hours.&#xD;
&#xD;
      Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72&#xD;
      hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of&#xD;
      the Hospital Español de México with a diagnosis of septic shock will be included.&#xD;
&#xD;
      Patients will be randomized to one of the study groups:&#xD;
&#xD;
      Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in&#xD;
      continuous infusion for 72 hours.&#xD;
&#xD;
      Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72&#xD;
      hours.&#xD;
&#xD;
      Bottles will be identical, only identified by the sequential number of the patient that has&#xD;
      been included.&#xD;
&#xD;
      Primary objective is to demonstrate that the administration of intravenous Vitamin C&#xD;
      decreases the dose of exogenous vasopressors in patients with septic shock&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2021</primary_completion_date>
  <phase>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>Vasopressor dose</measure>
    <time_frame>72 hours</time_frame>
    <description>Hourly dose of exogenous vasopressor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hours of vasopressor use</measure>
    <time_frame>through study completion, an average of 30 days</time_frame>
    <description>Total hours of vasopressor use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of mechanical ventilation</measure>
    <time_frame>through study completion, an average of 30 days</time_frame>
    <description>Total days of mechanical ventilation use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of Intensive Care Unit stay</measure>
    <time_frame>through study completion, an average of 30 days</time_frame>
    <description>Total days of intensive care unit stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality in Intensive Care Unit</measure>
    <time_frame>through study completion, an average of 30 days</time_frame>
    <description>Rate of intensive care mortality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Septic Shock</condition>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Vitamin C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vitamin C experimental group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebos Controlled group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin C</intervention_name>
    <description>6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.</description>
    <arm_group_label>Vitamin C</arm_group_label>
    <other_name>Ascorbic Acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults&#xD;
&#xD;
          -  Septic Shock&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment exceeded 24 hours&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Do Not Resuscitate&#xD;
&#xD;
          -  Participation in another trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo Martinez-Zubieta, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Español de Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Español</name>
      <address>
        <city>Mexico City</city>
        <zip>11520</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Español de Mexico</investigator_affiliation>
    <investigator_full_name>Jose J Zaragoza</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>critical care</keyword>
  <keyword>vitamin C</keyword>
  <keyword>vasopressor</keyword>
  <keyword>intensive care unit</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>Ascorbic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Complete database will be shared as requested by the publishing journal, once the study is completed</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Available one year after</ipd_time_frame>
    <ipd_access_criteria>Journal provided</ipd_access_criteria>
  </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/NCT03835286
org study id: EHE0042
nct id: NCT03835286
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of
      the Hospital Español de México with a diagnosis of septic shock will be included.

      Patients will be randomized to one of the study groups:

      Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in
      continuous infusion for 72 hours.

      Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72
      hours.
Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of
      the Hospital Español de México with a diagnosis of septic shock will be included.

      Patients will be randomized to one of the study groups:

      Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in
      continuous infusion for 72 hours.

      Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72
      hours.

      Bottles will be identical, only identified by the sequential number of the patient that has
      been included.

      Primary objective is to demonstrate that the administration of intravenous Vitamin C
      decreases the dose of exogenous vasopressors in patients with septic shock
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Vasopressor dose
time frame: 72 hours
description: Hourly dose of exogenous vasopressor
measure: Hours of vasopressor use
time frame: through study completion, an average of 30 days
description: Total hours of vasopressor use
measure: Days of mechanical ventilation
time frame: through study completion, an average of 30 days
description: Total days of mechanical ventilation use
measure: Days of Intensive Care Unit stay
time frame: through study completion, an average of 30 days
description: Total days of intensive care unit stay
measure: Mortality in Intensive Care Unit
time frame: through study completion, an average of 30 days
description: Rate of intensive care mortality
arm group label: Vitamin C
arm group type: Experimental
description: Vitamin C experimental group
arm group label: Control
arm group type: Placebo Comparator
description: Placebos Controlled group
intervention type: Drug
intervention name: Vitamin C
description: 6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
arm group label: Vitamin C
other name: Ascorbic Acid
intervention type: Drug
intervention name: Placebos
description: Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
arm group label: Control
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ricardo Martinez-Zubieta, MD
role: Study Chair
affiliation: Hospital Español de Mexico
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Hospital Español de Mexico
investigator full name: Jose J Zaragoza
investigator title: Clinical Professor
mesh term: Shock, Septic
mesh term: Shock
mesh term: Ascorbic Acid
sharing ipd: Yes
ipd description: Complete database will be shared as requested by the publishing journal, once the study is completed
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Available one year after
ipd access criteria: Journal provided