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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 13, 2005

Last Updated Date

June 11, 2008

Start Date ^†

January 2003

Current Primary Outcome Measures ^†

survival to hospital discharge with neurologic outcome [ Time Frame: discharge from hospital ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00121524 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

admit to hospital with spontaneous circulation [ Time Frame: hospital admission ] [ Designated as safety issue: No ]
one year survival with neurologic outcome [ Time Frame: one year after hospital discharge ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

admit to hospital with spontaneous circulation
one year survival with neurologic outcome

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief 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.

Detailed 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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Cardiac Arrest

Intervention ^†

Drug: epinephrine and intravenous needle

Study Arms / Comparison Groups

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

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

904

Completion Date

June 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Cardiac arrest out-of-hospital

Exclusion Criteria:

<18 years old
Trauma as cause of arrest

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Norway

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00121524

Responsible Party

Petter Andreas Steen/professor, University of Oslo and Ulleval University Hospital

Secondary IDs ^††

Study Sponsor ^†

University of Oslo

Collaborators ^††

Laerdal Medical
Ullevaal University Hospital
Health Region East, Norway
Norwegian Air Ambulance Foundation

Investigators ^†

Principal Investigator:

Lars Wik, MD, PhD

Ullevaal University Hospital

Information Provided By

University of Oslo

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.