Pharmacokinetics of Epinephrine During Cardiac Arrest

Completed

• Conditions: Cardiac Arrest
• Interventions: Drug: Epinephrine

• Registration Number: NCT03036202
• Lead Sponsor: Haukeland University Hospital

Brief Summary

To determine the pharmacokinetics of epinephrine during cardiac arrest.

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 Venous samples will be withdrawn every minute the first five minutes following a single dose.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

• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-30
• Study Start: 2017-06-26
• Primary Completion: 2018-07-12
• Status Verified: 2018-08
• Study Completion: 2018-10-12
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
one group	Epinephrine	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.

Primary Outcome Measures

Name	Time	Method
Concentration of epinephrine (ng/mL) as a function of time the first five minutes following administration	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.

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, N, Norway