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Completed

NCT Number: NCT03036202

Pharmacokinetics of Epinephrine During Cardiac Arrest

To determine the pharmacokinetics of epinephrine during cardiac arrest.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital

Bergen, N, 5021, Norway

About this study

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 Venous samples will be withdrawn every minute the first five minutes following a single dose.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epinephrine

Drug

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2017
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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