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Pharmacokinetics of Epinephrine During Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT03036202
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:
To determine the pharmacokinetics of epinephrine during cardiac arrest.

Condition or disease Intervention/treatment
Cardiac Arrest Drug: Epinephrine

Detailed Description:

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 Venous samples will be withdrawn every minute the first five minutes following a single dose.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.


Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacokinetic Study of Epinephrine During Cardiac Arrest Determining T1/2 and Time to Peak Concentration
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017


Group/Cohort Intervention/treatment
one group
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.
Drug: Epinephrine
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
Other Name: Adrenaline




Primary Outcome Measures :
  1. 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. ]
    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.


Biospecimen Retention:   Samples Without DNA
Blood samples with determination of medical concentration in plasma


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with cardiac arrest of an assumed cardiac origin, treated by the Bergen Emergency Medical Service.
Criteria

Inclusion Criteria:

  • Age 18-85 yrs
  • Witnessed non-traumatic cardiac arrest.
  • Probable cardiac origin
  • Treated by Bergen Emergency Medical Services

Exclusion Criteria:

  • Terminal illness
  • Residents of nursery homes
  • Obvious dead
  • Hypothermic patients
  • Epinephrine administered before arrival of study physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036202


Contacts
Contact: Baard E Heradstveit, MD, PhD 004755976850 baard.heradstveit@helse-bergen.no
Contact: Jon K Heltne, MD, PhD 004755976850 jkhe@helse-bergen.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, N, Norway, 5021
Contact: Baard E Heradstveit, MD, PhD    +4755976850    baard.heradstveit@helse-bergen.no   
Contact: Jon K Heltne, MD PhD    +4755976850    jkhe@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Baard E Heradstveit, MD, PhD Haukeland University Hospital

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03036202     History of Changes
Other Study ID Numbers: 1471-74
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual data available to other researchers. The data will be presented pooled and anonymously

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Haukeland University Hospital:
epinephrine

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents