Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome

Cardiac Arrest Clinical Trial

Official title:

Effects of Epinephrine and I.V. Needle on CPR Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121524
• Other study ID #: 525-02201
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2005
• Last updated: May 28, 2015
• Start date: January 2003
• Est. completion date: June 2008

Study information

• Verified date: May 2015
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.

Description:

In a randomized, controlled study of all out-of-hospital cardiac arrest patients in Oslo, Norway, half the patients are treated according to the international guidelines for advanced CPR, and the other half according to the same guidelines, except for no I.V. needle or drugs are given until 5 minutes after eventual return of spontaneous circulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 904
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cardiac arrest out-of-hospital

Exclusion Criteria:

• <18 years old

• Trauma as cause of arrest

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Drug:
• Epinephrine
Epinephrine 1 mg is given iv. every 3 min during CPR

Device:
• Intravenous needle
An intravenous needle in placed as soon as possible during CPR

Drug:
• Atropine
Atropine 3 mg iv in initial systole
• Amiodarone
amiodarone 300 mg iv after repeated failed defibrillation attempts

Locations

Country	Name	City	State
Norway	Ulleval University Hospital	Oslo

Sponsors (6)

Lead Sponsor	Collaborator
Petter Andreas Steen	Health Region East, Norway, Laerdal Medical, Norwegian Air Ambulance Foundation, Ullevaal University Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Holmberg M, Holmberg S, Herlitz J. Low chance of survival among patients requiring adrenaline (epinephrine) or intubation after out-of-hospital cardiac arrest in Sweden. Resuscitation. 2002 Jul;54(1):37-45. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival to hospital discharge with neurologic outcome		discharge from hospital	Yes
Secondary	admit to hospital with spontaneous circulation		hospital admission	No
Secondary	one year survival with neurologic outcome		one year after hospital discharge	Yes