Official Title: “Effects of Epinephrine and I.V. Needle on CPR Outcome”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2008

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.

Intervention(s) in this Clinical Trial

• Drug: epinephrine and intravenous needle
  • epinephrine 1 mg iv. q 3 min during CPR, atropin 3 mg iv in initial asystole, amiodarone 300 mg iv after repeated failed defibrillation attempts

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: IV yes
  • ACLS with an iv needle and the use of drugs during CPR
• No Intervention: IV no
  • No IV needle or drugs given during CPR

Primary Measures

• survival to hospital discharge with neurologic outcome
  • Time Frame: discharge from hospital
    Safety Issue?: Yes

Secondary Measures

• admit to hospital with spontaneous circulation
  • Time Frame: hospital admission
    Safety Issue?: No
• one year survival with neurologic outcome
  • Time Frame: one year after hospital discharge
    Safety Issue?: Yes

Inclusion Criteria:

• Cardiac arrest out-of-hospital

Exclusion Criteria:

• <18 years old
• Trauma as cause of arrest

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Oslo

Overall Clinical Trial Officials and Contacts

Lars Wik, MD, PhD Principal Investigator Ullevaal University Hospital  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00121524

Study ID Number: 525-02201

ClinicalTrials.gov Identifier: NCT00121524

Health Authority: Norway: The National Committees for Research Ethics in Norway