<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/NCT02987088</url>
  </required_header>
  <id_info>
    <org_study_id>51605-A</org_study_id>
    <nct_id>NCT02987088</nct_id>
  </id_info>
  <brief_title>Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest</brief_title>
  <official_title>Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the optimal dose of sodium nitrate administered&#xD;
      during resuscitation to achieve a plasma level of 10 μM by hospital arrival.&#xD;
&#xD;
      Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV&#xD;
      dose of sodium nitrite will achieve the optimal (based on preclinical studies)&#xD;
      neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100&#xD;
      patients, we will determine whether 25 mg IV administered during resuscitation will achieve&#xD;
      plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either&#xD;
      decreasing or increasing, will be made if necessary permitting us to determine the optimal&#xD;
      nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">May 2, 2017</completion_date>
  <primary_completion_date type="Actual">April 5, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>plasma level of sodium nitrite at hospital arrival</measure>
    <time_frame>15-45 minutes after dose has been given</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of re-arrest</measure>
    <time_frame>15-120 minutes after dose has been given</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for pressor support before hospital arrival</measure>
    <time_frame>15-120 minutes after dose has been given</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>blood pressure at hospital arrival</measure>
    <time_frame>at hospital arrival usually 15-60 minutes after cardiac arrest</time_frame>
  </other_outcome>
  <enrollment type="Actual">120</enrollment>
  <condition>Out-Of-Hospital Cardiac Arrest</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Nitrite</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Intravenous access/intraosseous access&#xD;
&#xD;
          2. Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One&#xD;
             paramedics.&#xD;
&#xD;
          3. Age 18 years or older&#xD;
&#xD;
          4. Comatose&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Traumatic cause of cardiac arrest&#xD;
&#xD;
          2. Prisoner, pregnancy, age less than 18 (special population/vulnerable population)&#xD;
&#xD;
          3. Known DNAR&#xD;
&#xD;
          4. Drowning as cause of arrest.&#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>Francis Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Francis Kim</investigator_full_name>
    <investigator_title>Associate Professor, Medicine/Division of Cardiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Out-of-Hospital Cardiac Arrest</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/NCT02987088
org study id: 51605-A
nct id: NCT02987088
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the optimal dose of sodium nitrate administered
      during resuscitation to achieve a plasma level of 10 μM by hospital arrival.

      Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV
      dose of sodium nitrite will achieve the optimal (based on preclinical studies)
      neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100
      patients, we will determine whether 25 mg IV administered during resuscitation will achieve
      plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either
      decreasing or increasing, will be made if necessary permitting us to determine the optimal
      nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: plasma level of sodium nitrite at hospital arrival
time frame: 15-45 minutes after dose has been given
measure: Rate of re-arrest
time frame: 15-120 minutes after dose has been given
measure: Need for pressor support before hospital arrival
time frame: 15-120 minutes after dose has been given
measure: blood pressure at hospital arrival
time frame: at hospital arrival usually 15-60 minutes after cardiac arrest
intervention type: Drug
intervention name: Sodium Nitrite
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francis Kim, MD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Francis Kim
investigator title: Associate Professor, Medicine/Division of Cardiology
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest
sharing ipd: No