<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/NCT01676454</url>
  </required_header>
  <id_info>
    <org_study_id>Vasopressin Study</org_study_id>
    <nct_id>NCT01676454</nct_id>
  </id_info>
  <brief_title>Serum Vasopressin Levels and Severe Hemorrhagic Shock</brief_title>
  <official_title>Determination of Serum Vasopressin Levels and Correlation With Life-threatening Complications in Adults With Severe Hemorrhagic Shock.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poudre Valley Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poudre Valley Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if vasopressin is used up by the body during&#xD;
      traumatic shock (severe low blood pressure due to trauma).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For humans suffering trauma and severe hemorrhagic shock, no randomized controlled studies of&#xD;
      the effect of exogenous vasopressin use exist, although case reports have suggested it may be&#xD;
      of benefit. Even some moribund patients with &quot;irreversible&quot; shock survived severe hemorrhagic&#xD;
      shock after administration of vasopressin. This suggests that at least some patients&#xD;
      suffering severe trauma could benefit from AAVP administration. Recently, many clinicians and&#xD;
      notable research consortiums have suggested that AVP shows promise for human resuscitation&#xD;
      and have called for further human studies.&#xD;
&#xD;
      This is a prospective, single-center observational study designed to evaluate (1) whether&#xD;
      vasopressin is depleted in severe, but not minor, trauma; and (2) the degree to which&#xD;
      endogenous vasopressin levels predict the occurrence of ARDS, sepsis, or death. To test the&#xD;
      first hypothesis, serum vasopressin levels (continuous independent variable) will be assessed&#xD;
      at enrollment (time 0), 6, 12, 18, and 24 hours later, and correlated with the two levels of&#xD;
      trauma (categorical dependent variable). To test the second hypothesis, serum vasopressin&#xD;
      levels (now a continuous dependent variable) will be correlated with each of three&#xD;
      outcomes-death, ARDS, and sepsis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study closed without enrollment .&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum vasopressin levels.</measure>
    <time_frame>24 hours.</time_frame>
    <description>6 mL's per blood draw for 5 timepoints=30 mL's total blood drawn.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Injury</condition>
  <arm_group>
    <arm_group_label>Vasopressin levels.</arm_group_label>
    <description>Cohort will consist of subjects with a minor injury or injuries defined as:&#xD;
no episodes of systolic blood pressure &lt; 90 mmHg between occurrence of injury and admission;&#xD;
no blood transfusion requirement;&#xD;
base deficit &lt; 5 mEq/L;&#xD;
no requirement for mechanical ventilation other than transiently during orthopedic surgery.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to Medical Center of the Rockies with minor injuries.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with a minor injury or injuries, defined as:&#xD;
&#xD;
          1. no episodes of systolic blood pressure &lt; 90 mmHg between occurrence of injury and&#xD;
             admission;&#xD;
&#xD;
          2. no blood transfusion requirement;&#xD;
&#xD;
          3. base deficit &lt; 5 mEq/L;&#xD;
&#xD;
          4. no requirement for mechanical ventilation other than transiently during orthopedic&#xD;
             surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. corticosteroid use,&#xD;
&#xD;
          3. prisoners, and/or&#xD;
&#xD;
          4. head trauma as determined by computed tomography (head trauma may itself induce&#xD;
             diabetes insipidus, a marker of pituitary damage and vasopressin deficiency), and/or&#xD;
&#xD;
          5. evidence of spinal cord injury (another cause of vasodilatory shock).&#xD;
&#xD;
        Patients will also be excluded if pre-hospital provider information cannot be obtained, or&#xD;
        indicates that the trauma occurred more than one 1 hour prior to emergency department&#xD;
        admission.&#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>Julie Dunn, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Poudre Valley Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Center of the Rockies</name>
      <address>
        <city>Loveland</city>
        <state>Colorado</state>
        <zip>80538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://pvhs.org/research</url>
    <description>System website</description>
  </link>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>May 24, 2018</last_update_submitted>
  <last_update_submitted_qc>May 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Poudre Valley Health System</investigator_affiliation>
    <investigator_full_name>Julie Dunn, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Vasopressin</keyword>
  <keyword>Trauma</keyword>
  <keyword>Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Hemorrhagic</mesh_term>
  </condition_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/NCT01676454
org study id: Vasopressin Study
nct id: NCT01676454
lead sponsor: 
has dmc: No
The purpose of this study is to determine if vasopressin is used up by the body during
      traumatic shock (severe low blood pressure due to trauma).
For humans suffering trauma and severe hemorrhagic shock, no randomized controlled studies of
      the effect of exogenous vasopressin use exist, although case reports have suggested it may be
      of benefit. Even some moribund patients with "irreversible" shock survived severe hemorrhagic
      shock after administration of vasopressin. This suggests that at least some patients
      suffering severe trauma could benefit from AAVP administration. Recently, many clinicians and
      notable research consortiums have suggested that AVP shows promise for human resuscitation
      and have called for further human studies.

      This is a prospective, single-center observational study designed to evaluate (1) whether
      vasopressin is depleted in severe, but not minor, trauma; and (2) the degree to which
      endogenous vasopressin levels predict the occurrence of ARDS, sepsis, or death. To test the
      first hypothesis, serum vasopressin levels (continuous independent variable) will be assessed
      at enrollment (time 0), 6, 12, 18, and 24 hours later, and correlated with the two levels of
      trauma (categorical dependent variable). To test the second hypothesis, serum vasopressin
      levels (now a continuous dependent variable) will be correlated with each of three
      outcomes-death, ARDS, and sepsis.
observational model: Cohort
time perspective: Prospective
measure: Serum vasopressin levels.
time frame: 24 hours.
description: 6 mL's per blood draw for 5 timepoints=30 mL's total blood drawn.
arm group label: Vasopressin levels.
description: Cohort will consist of subjects with a minor injury or injuries defined as:
no episodes of systolic blood pressure < 90 mmHg between occurrence of injury and admission;
no blood transfusion requirement;
base deficit < 5 mEq/L;
no requirement for mechanical ventilation other than transiently during orthopedic surgery.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julie Dunn, M.D.
role: Principal Investigator
affiliation: Poudre Valley Health System
facility: 
country: United States
url: http://pvhs.org/research
description: System website
responsible party type: Principal Investigator
investigator affiliation: Poudre Valley Health System
investigator full name: Julie Dunn, M.D.
investigator title: Principal Investigator
mesh term: Shock, Hemorrhagic
sharing ipd: No