Pharmacokinetics of Epinephrine During Cardiac Arrest
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03036202|
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment|
|Cardiac Arrest||Drug: Epinephrine|
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 Venous samples will be withdrawn every minute the first five minutes following a single dose.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|
|Estimated Enrollment :||10 participants|
|Official Title:||Pharmacokinetic Study of Epinephrine During Cardiac Arrest Determining T1/2 and Time to Peak Concentration|
|Actual Study Start Date :||June 26, 2017|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 31, 2017|
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.
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 Name: Adrenaline
- 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036202
|Contact: Baard E Heradstveit, MD, PhDemail@example.com|
|Contact: Jon K Heltne, MD, PhDfirstname.lastname@example.org|
|Haukeland University Hospital||Recruiting|
|Bergen, N, Norway, 5021|
|Contact: Baard E Heradstveit, MD, PhD +4755976850 email@example.com|
|Contact: Jon K Heltne, MD PhD +4755976850 firstname.lastname@example.org|
|Principal Investigator:||Baard E Heradstveit, MD, PhD||Haukeland University Hospital|