Pharmacokinetics of Epinephrine During Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036202
• Other study ID #: 1471-74
• Status: Completed
• Start date: June 26, 2017
• Est. completion date: October 12, 2018

Study information

• Verified date: August 2018
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine the pharmacokinetics of epinephrine during cardiac arrest.

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 Venous samples will be withdrawn every minute the first five minutes following a single dose.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	N

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.