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Pre-hospital assessment of the role of adrenaline : measuring the effectiveness of drug administration in cardiac arrest (PARAMEDIC-2) : Trial protocol

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Perkins, Gavin D., Quinn, Tom, Deakin, Charles D., Nolan, Jerry, Lall, Ranjit, Slowther, Anne, Cooke, Matthew, Lamb, S. E. (Sallie E.), Petrou, Stavros, Achana, Felix A. et al.
(2016) Pre-hospital assessment of the role of adrenaline : measuring the effectiveness of drug administration in cardiac arrest (PARAMEDIC-2) : Trial protocol. Resuscitation, 108 . pp. 75-81. doi:10.1016/j.resuscitation.2016.08.029

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Official URL: http://doi.org/10.1016/j.resuscitation.2016.08.029

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Abstract

Despite its use since the 1960s, the safety or effectiveness of adrenaline as a treatment for cardiac arrest has never been comprehensively evaluated in a clinical trial. Although most studies have found that adrenaline increases the chance of return of spontaneous circulation for short periods, many studies found harmful effects on the brain and raise concern that adrenaline may reduce overall survival and/or good neurological outcome. The PARAMEDIC-2 trial seeks to determine if adrenaline is safe and effective in out-of-hospital cardiac arrest. This is a pragmatic, individually randomised, double blind, controlled trial with a parallel economic evaluation. Participants will be eligible if they are in cardiac arrest in the out-of-hospital environment and advanced life support is initiated. Exclusions are cardiac arrest as a result of anaphylaxis or life threatening asthma, and patient known or appearing to be under 16 or pregnant. 8000 participants treated by 5 UK ambulance services will be randomised between December 2014-August 2017 to adrenaline (intervention) or placebo (control) through opening pre-randomised drug packs. Clinical outcomes are survival to 30 days (primary outcome), hospital discharge, 3, 6 and 12 months, health related quality of life, and neurological and cognitive outcomes (secondary outcomes).

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Cardiac arrest -- Treatment -- Safety measures, Cardiac arrest -- Treatment -- Effectiveness, Adrenaline, Clinical trials
Journal or Publication Title: Resuscitation
Publisher: Elsevier Ireland Ltd
ISSN: 0300-9572
Official Date: November 2016
Dates:
DateEvent
November 2016Published
17 September 2016Available
26 August 2016Accepted
Volume: 108
Page Range: pp. 75-81
DOI: 10.1016/j.resuscitation.2016.08.029
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
Funder: National Institute for Health Research (Great Britain) (NIHR)
Grant number: Project number HTA – 12/127/126 (NIHR)
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