Pharmacokinetics of Epinephrine During Cardiac Arrest

NCT03036202 | Completed DMC FDA Drug

• 1 other identifier: 1471-74
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the pharmacokinetics of epinephrine during cardiac arrest.

Conditions

Cardiac Arrest

Keywords

epinephrine

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

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

Also known as: Adrenaline

one group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, N, 5021, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples with determination of medical concentration in plasma

MeSH Terms

Conditions

Heart Arrest

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Baard E Heradstveit, MD, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 30, 2017
• Study Start: June 26, 2017
• Primary Completion: July 12, 2018
• Study Completion: October 12, 2018
• Last Updated: August 21, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)