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Completed

NCT Number: NCT00121524

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ulleval University Hospital

Oslo, N-0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cardiac arrest out-of-hospital

Exclusion criteria

  • <18 years old
  • Trauma as cause of arrest

Treatment and study plan

Epinephrine

Drug

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

Other names: Adrenaline

Intravenous needle

Device

An intravenous needle in placed as soon as possible during CPR

Atropine

Drug

Atropine 3 mg iv in initial systole

Other names: Atropine sulfate

Amiodarone

Drug

amiodarone 300 mg iv after repeated failed defibrillation attempts

Other names: Amiodaron

Primary outcomes

  1. survival to hospital discharge with neurologic outcome

    Time frame: discharge from hospital

Secondary outcomes

  1. admit to hospital with spontaneous circulation

    Time frame: hospital admission

  2. one year survival with neurologic outcome

    Time frame: one year after hospital discharge

Sponsors and collaborators

Lead sponsor

Petter Andreas Steen

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jul 21, 2005
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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