Pharmacokinetics of Epinephrine During Cardiac Arrest

Pharmacokinetic Study of Epinephrine During Cardiac Arrest Determining T1/2 and Time to Peak Concentration

To determine the pharmacokinetics of epinephrine during cardiac arrest.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: 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 Venous samples will be withdrawn every minute the first five minutes following a single dose.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
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Norway
  • N
    • Bergen, N, Norway, 5021
      • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with cardiac arrest of an assumed cardiac origin, treated by the Bergen Emergency Medical Service.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Adrenaline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of epinephrine (ng/mL) as a function of time the first five minutes following administration	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.	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.

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Baard E Heradstveit, MD, PhD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2017
• Primary Completion (Actual): July 12, 2018
• Study Completion (Actual): October 12, 2018

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: epinephrine
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine
• Other Study ID Numbers: 1471-74

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual data available to other researchers. The data will be presented pooled and anonymously

Drug and device information, study documents

• 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