Back to results

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

Primary Purpose

Cardiac Arrest

Status

Completed

Phase

Phase 2

Locations

Norway

Study Type

Interventional

Intervention

Epinephrine

Intravenous needle

Atropine

Amiodarone

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, resuscitation, epinephrine, intravenous, survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ulleval University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IV yes

IV no

Arm Description

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

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.

Outcomes

Primary Outcome Measures

survival to hospital discharge with neurologic outcome

Secondary Outcome Measures

admit to hospital with spontaneous circulation

one year survival with neurologic outcome

Full Information

NCT ID

NCT00121524

First Posted

July 13, 2005

Last Updated

May 28, 2015

Sponsor

Petter Andreas Steen

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00121524

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Petter Andreas Steen

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrest

Keywords

cardiac arrest, resuscitation, epinephrine, intravenous, survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

904 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV yes

Arm Type

Experimental

Arm Description

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

Arm Title

IV no

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Epinephrine

Other Intervention Name(s)

Adrenaline

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Intravenous needle

Intervention Description

An intravenous needle in placed as soon as possible during CPR

Intervention Type

Drug

Intervention Name(s)

Atropine

Other Intervention Name(s)

Atropine sulfate

Intervention Description

Atropine 3 mg iv in initial systole

Intervention Type

Drug

Intervention Name(s)

Amiodarone

Other Intervention Name(s)

Amiodaron

Intervention Description

amiodarone 300 mg iv after repeated failed defibrillation attempts

Primary Outcome Measure Information:

Title

survival to hospital discharge with neurologic outcome

Time Frame

discharge from hospital

Secondary Outcome Measure Information:

Title

admit to hospital with spontaneous circulation

Time Frame

hospital admission

Title

one year survival with neurologic outcome

Time Frame

one year after hospital discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lars Wik, MD, PhD

Organizational Affiliation

Ullevaal University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ulleval University Hospital

City

Oslo

ZIP/Postal Code

N-0407

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

12104107

Citation

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.

Results Reference

background

PubMed Identifier

19934423

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs