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

This study has been completed.
Sponsor:
Collaborators:
Laerdal Medical
Ullevaal University Hospital
Health Region East, Norway
Norwegian Air Ambulance Foundation
University of Oslo
Information provided by (Responsible Party):
Petter Andreas Steen, University of Oslo
ClinicalTrials.gov Identifier:
NCT00121524
First received: July 13, 2005
Last updated: May 28, 2015
Last verified: May 2015

July 13, 2005
May 28, 2015
January 2003
May 2008   (final data collection date for primary outcome measure)
survival to hospital discharge with neurologic outcome [ Time Frame: discharge from hospital ] [ Designated as safety issue: Yes ]
survival to hospital discharge with neurologic outcome
Complete list of historical versions of study NCT00121524 on ClinicalTrials.gov Archive Site
  • 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 ]
  • admit to hospital with spontaneous circulation
  • one year survival with neurologic outcome
Not Provided
Not Provided
 
Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cardiac Arrest
  • Drug: Epinephrine
    Epinephrine 1 mg is given iv. every 3 min during CPR
    Other Name: Adrenaline
  • Device: Intravenous needle
    An intravenous needle in placed as soon as possible during CPR
  • Drug: Atropine
    Atropine 3 mg iv in initial systole
    Other Name: Atropine sulfate
  • Drug: Amiodarone
    amiodarone 300 mg iv after repeated failed defibrillation attempts
    Other Name: Amiodaron
  • Experimental: IV yes
    Intravenous needle Epinephrine q 3 min during CPR Atropine 3 mg in initial asystole Amiodarone 300 mg iv after repeated failed defibrillation attempts
    Interventions:
    • Drug: Epinephrine
    • Device: Intravenous needle
    • Drug: Atropine
    • Drug: Amiodarone
  • No Intervention: IV no
    The patient will not have an intravenous needle placed or given any drugs during CPR. If patient obtains spontaneous circulation, an intravenous needle is placed and patient can receive any drugs that are appropriate during the following treatment.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
904
June 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cardiac arrest out-of-hospital

Exclusion Criteria:

  • <18 years old
  • Trauma as cause of arrest
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00121524
525-02201
Yes
Petter Andreas Steen, University of Oslo
Petter Andreas Steen
  • Laerdal Medical
  • Ullevaal University Hospital
  • Health Region East, Norway
  • Norwegian Air Ambulance Foundation
  • University of Oslo
Principal Investigator: Lars Wik, MD, PhD Ullevaal University Hospital
University of Oslo
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP