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

Sponsor:	University of Oslo
Collaborators:	Laerdal Medical Ullevaal University Hospital Health Region East, Norway Norwegian Air Ambulance Foundation
Information provided by:	University of Oslo
ClinicalTrials.gov Identifier:	NCT00121524

Purpose

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.

Condition	Intervention	Phase
Cardiac Arrest	Drug: epinephrine and intravenous needle	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Epinephrine and I.V. Needle on CPR Outcome

Resource links provided by NLM:

MedlinePlus related topics: CPR

Drug Information available for: Epinephrine bitartrate Epinephrine

U.S. FDA Resources

Further study details as provided by University of Oslo:

Primary Outcome Measures:

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

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 ]

Enrollment:	904
Study Start Date:	January 2003
Study Completion Date:	June 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cardiac arrest out-of-hospital

Exclusion Criteria:

<18 years old
Trauma as cause of arrest

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121524

Locations

Norway
Ulleval University Hospital
Oslo, Norway, N-0407

Sponsors and Collaborators

University of Oslo

Laerdal Medical

Ullevaal University Hospital

Health Region East, Norway

Norwegian Air Ambulance Foundation

Investigators

Principal Investigator:

Lars Wik, MD, PhD

Ullevaal University Hospital

More Information

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Olasveengen TM, Sunde K, Brunborg C, Thowsen J, Steen PA, Wik L. Intravenous drug administration during out-of-hospital cardiac arrest: a randomized trial. JAMA. 2009 Nov 25;302(20):2222-9.

Responsible Party:	University of Oslo and Ulleval University Hospital ( Petter Andreas Steen/professor )
Study ID Numbers:	525-02201
Study First Received:	July 13, 2005
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00121524 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by University of Oslo:

cardiac arrest
resuscitation
epinephrine
intravenous
survival

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Heart Diseases
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Anti-Asthmatic Agents
Heart Arrest

Cardiovascular Agents
Adrenergic Agonists
Pharmacologic Actions
Mydriatics
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases
Peripheral Nervous System Agents
Epinephrine
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010