NCT00121524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
904

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

5.3 years

First QC Date

July 13, 2005

Last Update Submit

May 28, 2015

Conditions

Cardiac Arrest

Keywords

cardiac arrestresuscitationepinephrineintravenoussurvival

Outcome Measures

Primary Outcomes (1)

  • survival to hospital discharge with neurologic outcome

    discharge from hospital

Secondary Outcomes (2)

  • admit to hospital with spontaneous circulation

    hospital admission

  • one year survival with neurologic outcome

    one year after hospital discharge

Study Arms (2)

IV yes

EXPERIMENTAL

Intravenous needle Epinephrine q 3 min during CPR Atropine 3 mg in initial asystole Amiodarone 300 mg iv after repeated failed defibrillation attempts

Drug: EpinephrineDevice: Intravenous needleDrug: AtropineDrug: Amiodarone

IV no

NO INTERVENTION

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.

Interventions

EpinephrineDRUG

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

Also known as: Adrenaline
IV yes
Intravenous needleDEVICE

An intravenous needle in placed as soon as possible during CPR

IV yes
AtropineDRUG

Atropine 3 mg iv in initial systole

Also known as: Atropine sulfate
IV yes
AmiodaroneDRUG

amiodarone 300 mg iv after repeated failed defibrillation attempts

Also known as: Amiodaron
IV yes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac arrest out-of-hospital

You may not qualify if:

  • \<18 years old
  • Trauma as cause of arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulleval University Hospital

Oslo, N-0407, Norway

Location

Related Publications (2)

  • 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.

    PMID: 12104107BACKGROUND

  • 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.

    PMID: 19934423DERIVED

MeSH Terms

Conditions

Heart Arrest

Interventions

EpinephrineAtropineAmiodarone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Lars Wik, MD, PhD

    Ullevaal University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Acute Medicine

Study Record Dates

First Submitted

July 13, 2005

First Posted

July 21, 2005

Study Start

January 1, 2003

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

NO(1)