<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/NCT01718613</url>
  </required_header>
  <id_info>
    <org_study_id>NP 1079/17</org_study_id>
    <nct_id>NCT01718613</nct_id>
  </id_info>
  <brief_title>Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients</brief_title>
  <acronym>VANCS II</acronym>
  <official_title>Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto do Cancer do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto do Cancer do Estado de São Paulo</source>
  <brief_summary>
    <textblock>
      Although arginine vasopressin has been used as an additional drug in refractory shock in&#xD;
      worldwide clinical practice, there are no prospective studies using it as a first choice&#xD;
      therapy in patients with cancer and septic shock.&#xD;
&#xD;
      The aim of this study is assess if the use of arginine vasopressin would be more effective on&#xD;
      treatment of septic shock in cancer patients than norepinephrine, decreasing the composite&#xD;
      end point of mortality and organ failure in 28 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">March 2014</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>28-day mortality</measure>
    <time_frame>28-day from randomization</time_frame>
    <description>Mortality from all causes in 28-day follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>90-days mortality</measure>
    <time_frame>90 days after randomization</time_frame>
    <description>Mortality from all causes 90 days after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days alive and free of mechanical ventilation</measure>
    <time_frame>28 days after randomization</time_frame>
    <description>Days alive and free of mechanical ventilation at 28-day follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days alive and free of vasopressors</measure>
    <time_frame>28 days after randomization</time_frame>
    <description>Days alive and free of any type of vasopressor agent at 28-day follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days alive and free of renal replacement therapy</measure>
    <time_frame>28 days after randomization</time_frame>
    <description>requirement of dialysis of hemofiltration at 28-day follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOFA score in 24 hours</measure>
    <time_frame>24 hours after ICU admission</time_frame>
    <description>Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 24 hours after randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOFA score in 96 hours</measure>
    <time_frame>96 hours after randomization</time_frame>
    <description>Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 96 hours after randomization.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Norepinephrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Vasopressin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vasopressin</intervention_name>
    <description>Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure &lt;65 mmHg after fluid replacement</description>
    <arm_group_label>Vasopressin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine</intervention_name>
    <description>Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure &lt;65 mmHg after fluid replacement</description>
    <arm_group_label>Norepinephrine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Solid neoplasm needing ICU&#xD;
&#xD;
          -  Septic Shock according standard criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;&#xD;
&#xD;
          -  Severe hyponatremia (Na&lt;130mEq/L);&#xD;
&#xD;
          -  Acute mesenteric ischemia;&#xD;
&#xD;
          -  Acute myocardial infarction;&#xD;
&#xD;
          -  Cardiogenic shock;&#xD;
&#xD;
          -  Current use of vasopressor before randomization&#xD;
&#xD;
          -  Expected ICU stay less than 24 hours&#xD;
&#xD;
          -  Enrolled in another study;&#xD;
&#xD;
          -  Refusal to consent.&#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>Cristiane M Zambolim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto do Cancer do Estado de Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <state>Sao Paulo/SP</state>
        <zip>01246000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>May 16, 2018</last_update_submitted>
  <last_update_submitted_qc>May 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto do Cancer do Estado de São Paulo</investigator_affiliation>
    <investigator_full_name>Cristiane Maciel Zambolim</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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>Vasopressins</mesh_term>
    <mesh_term>Arginine Vasopressin</mesh_term>
    <mesh_term>Norepinephrine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01718613
org study id: NP 1079/17
nct id: NCT01718613
lead sponsor: 
Although arginine vasopressin has been used as an additional drug in refractory shock in
      worldwide clinical practice, there are no prospective studies using it as a first choice
      therapy in patients with cancer and septic shock.

      The aim of this study is assess if the use of arginine vasopressin would be more effective on
      treatment of septic shock in cancer patients than norepinephrine, decreasing the composite
      end point of mortality and organ failure in 28 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 28-day mortality
time frame: 28-day from randomization
description: Mortality from all causes in 28-day follow-up
measure: 90-days mortality
time frame: 90 days after randomization
description: Mortality from all causes 90 days after randomization
measure: Days alive and free of mechanical ventilation
time frame: 28 days after randomization
description: Days alive and free of mechanical ventilation at 28-day follow-up
measure: Days alive and free of vasopressors
time frame: 28 days after randomization
description: Days alive and free of any type of vasopressor agent at 28-day follow-up
measure: Days alive and free of renal replacement therapy
time frame: 28 days after randomization
description: requirement of dialysis of hemofiltration at 28-day follow-up
measure: SOFA score in 24 hours
time frame: 24 hours after ICU admission
description: Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 24 hours after randomization.
measure: SOFA score in 96 hours
time frame: 96 hours after randomization
description: Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 96 hours after randomization.
arm group label: Norepinephrine
arm group type: Active Comparator
arm group label: Vasopressin
arm group type: Active Comparator
intervention type: Drug
intervention name: Vasopressin
description: Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
arm group label: Vasopressin
intervention type: Drug
intervention name: Norepinephrine
description: Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
arm group label: Norepinephrine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cristiane M Zambolim, MD
role: Principal Investigator
affiliation: Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Instituto do Cancer do Estado de São Paulo
investigator full name: Cristiane Maciel Zambolim
investigator title: Principal Investigator
mesh term: Shock, Septic
mesh term: Shock
mesh term: Vasopressins
mesh term: Arginine Vasopressin
mesh term: Norepinephrine