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

Study Overview
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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.

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

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Drug: Epinephrine
* Device: Intravenous needle
* Drug: Atropine
* Drug: Amiodarone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiac arrest out-of-hospital Exclusion Criteria: <18 years old Trauma as cause of arrest

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV yes<br>Intravenous needle Epinephrine q 3 min during CPR Atropine 3 mg in initial asystole Amiodarone 300 mg iv after repeated failed defibrillation attempts | Drug: Epinephrine<br>* Epinephrine 1 mg is given iv. every 3 min during CPR<br>* Other names: Adrenaline;Device: Intravenous needle<br>* An intravenous needle in placed as soon as possible during CPR<br>Drug: Atropine<br>* Atropine 3 mg iv in initial systole<br>* Other names: Atropine sulfate;Drug: Amiodarone<br>* amiodarone 300 mg iv after repeated failed defibrillation attempts<br>* Other names: Amiodaron;|
| No Intervention: IV no<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival to hospital discharge with neurologic outcome |  | discharge from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| admit to hospital with spontaneous circulation |  | hospital admission | 
| one year survival with neurologic outcome |  | one year after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrest, resuscitation, epinephrine, intravenous, survival