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

NCT ID: NCT00121524

Last Updated: 2015-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

904 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Epinephrine

Intervention Type DRUG

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

Intravenous needle

Intervention Type DEVICE

An intravenous needle in placed as soon as possible during CPR

Atropine

Intervention Type DRUG

Atropine 3 mg iv in initial systole

Amiodarone

Intervention Type DRUG

amiodarone 300 mg iv after repeated failed defibrillation attempts

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Epinephrine

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

Intervention Type DRUG

Intravenous needle

An intravenous needle in placed as soon as possible during CPR

Intervention Type DEVICE

Atropine

Atropine 3 mg iv in initial systole

Intervention Type DRUG

Amiodarone

amiodarone 300 mg iv after repeated failed defibrillation attempts

Intervention Type DRUG

Other Intervention Names

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Adrenaline Atropine sulfate Amiodaron

Eligibility Criteria

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Inclusion Criteria

* Cardiac arrest out-of-hospital

Exclusion Criteria

* \<18 years old
* Trauma as cause of arrest
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laerdal Medical

INDUSTRY

Sponsor Role collaborator

Ullevaal University Hospital

OTHER

Sponsor Role collaborator

Health Region East, Norway

OTHER

Sponsor Role collaborator

Norwegian Air Ambulance Foundation

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Petter Andreas Steen

OTHER

Sponsor Role lead

Responsible Party

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Petter Andreas Steen

Professor Acute Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lars Wik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ullevaal University Hospital

Locations

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Ulleval University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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. doi: 10.1016/s0300-9572(02)00048-5.

Reference Type BACKGROUND
PMID: 12104107 (View on PubMed)

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. doi: 10.1001/jama.2009.1729.

Reference Type DERIVED
PMID: 19934423 (View on PubMed)

Other Identifiers

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525-02201

Identifier Type: -

Identifier Source: org_study_id

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