<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/NCT03036202</url>
  </required_header>
  <id_info>
    <org_study_id>1471-74</org_study_id>
    <nct_id>NCT03036202</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Epinephrine During Cardiac Arrest</brief_title>
  <official_title>Pharmacokinetic Study of Epinephrine During Cardiac Arrest Determining T1/2 and Time to Peak Concentration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the pharmacokinetics of epinephrine during cardiac arrest.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of out study is to determine the pharmacokinetics in humans during cardiac arrest,&#xD;
      following a single dose of epinephrine. Venous samples will be withdrawn every minute the&#xD;
      first five minutes following a single dose.&#xD;
&#xD;
      The aim of the study is to determine T1/2 in a clinical setting and to determine time to peak&#xD;
      concentration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2017</start_date>
  <completion_date type="Actual">October 12, 2018</completion_date>
  <primary_completion_date type="Actual">July 12, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration of epinephrine (ng/mL) as a function of time the first five minutes following administration</measure>
    <time_frame>Blood samples will be drawn within minutes, and the survivors transported to hospital. The data according to Utstein-style, will also be collected. Blood samples will be analysed within weeks.Total timeframe for the study is estimated to one year.</time_frame>
    <description>Blood concentration of epinephrine will be determined the first five minutes following administration. For every minute starting With administration of epinephrine, blood samples will be drawn to determine the concentration (ng/mL). In total, six samples will be drawn. The administered dose (1 mg) will also be related to the patients weight, either estimated, or for those survivors admitted to hospital, measured in the Intensive Care Unit. Further, data according to the Utstein-template will be recorded.However, the primary outcome is to determine the plasma concentrations in every patients the first five minutes.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">8</enrollment>
  <condition>Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>one group</arm_group_label>
    <description>All patients treated for cardiac arrest, meeting our inclusions criteria will be enrolled in the study. No interventions regarding the national guidelines will be jeopardized, as the plasma concentration following a single dose of epinephrine will be measured in all patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epinephrine</intervention_name>
    <description>This is truly an observational study to determine T1/2 for epinephrine and time to peak concentration following a single dose of epinephrine in a cardiac arrest setting</description>
    <arm_group_label>one group</arm_group_label>
    <other_name>Adrenaline</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples with determination of medical concentration in plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with cardiac arrest of an assumed cardiac origin, treated by the Bergen Emergency&#xD;
        Medical Service.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-85 yrs&#xD;
&#xD;
          -  Witnessed non-traumatic cardiac arrest.&#xD;
&#xD;
          -  Probable cardiac origin&#xD;
&#xD;
          -  Treated by Bergen Emergency Medical Services&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Terminal illness&#xD;
&#xD;
          -  Residents of nursery homes&#xD;
&#xD;
          -  Obvious dead&#xD;
&#xD;
          -  Hypothermic patients&#xD;
&#xD;
          -  Epinephrine administered before arrival of study physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Baard E Heradstveit, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haukeland University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <state>N</state>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>August 20, 2019</last_update_submitted>
  <last_update_submitted_qc>August 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>epinephrine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual data available to other researchers. The data will be presented pooled and anonymously</ipd_description>
  </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/NCT03036202
org study id: 1471-74
nct id: NCT03036202
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To determine the pharmacokinetics of epinephrine during cardiac arrest.
The aim of out study is to determine the pharmacokinetics in humans during cardiac arrest,
      following a single dose of epinephrine. Venous samples will be withdrawn every minute the
      first five minutes following a single dose.

      The aim of the study is to determine T1/2 in a clinical setting and to determine time to peak
      concentration.
observational model: Case-Only
time perspective: Prospective
measure: Concentration of epinephrine (ng/mL) as a function of time the first five minutes following administration
time frame: Blood samples will be drawn within minutes, and the survivors transported to hospital. The data according to Utstein-style, will also be collected. Blood samples will be analysed within weeks.Total timeframe for the study is estimated to one year.
description: Blood concentration of epinephrine will be determined the first five minutes following administration. For every minute starting With administration of epinephrine, blood samples will be drawn to determine the concentration (ng/mL). In total, six samples will be drawn. The administered dose (1 mg) will also be related to the patients weight, either estimated, or for those survivors admitted to hospital, measured in the Intensive Care Unit. Further, data according to the Utstein-template will be recorded.However, the primary outcome is to determine the plasma concentrations in every patients the first five minutes.
arm group label: one group
description: All patients treated for cardiac arrest, meeting our inclusions criteria will be enrolled in the study. No interventions regarding the national guidelines will be jeopardized, as the plasma concentration following a single dose of epinephrine will be measured in all patient.
intervention type: Drug
intervention name: Epinephrine
description: This is truly an observational study to determine T1/2 for epinephrine and time to peak concentration following a single dose of epinephrine in a cardiac arrest setting
arm group label: one group
other name: Adrenaline
Blood samples with determination of medical concentration in plasma
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Baard E Heradstveit, MD, PhD
role: Principal Investigator
affiliation: Haukeland University Hospital
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Heart Arrest
mesh term: Epinephrine
sharing ipd: No
ipd description: There is no plan to make individual data available to other researchers. The data will be presented pooled and anonymously