Pre-hospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug administration In Cardiac arrest (PARAMEDIC-2): Trial protocol

被引：42

作者：

Perkins, Gavin D. ^{[1
,2
]}

Quinn, Tom ^{[3
,4
]}

Deakin, Charles D. ^{[5
,6
]}

Nolan, Jerry P. ^{[7
,8
]}

Lall, Ranjit ^{[1
]}

Slowther, Anne-Marie ^{[1
]}

Cooke, Matthew ^{[1
,2
]}

Lamb, Sarah E. ^{[9
]}

Petrou, Stavros ^{[1
]}

Achana, Felix ^{[1
]}

Finn, Judith ^{[10
,11
,12
]}

Jacobs, Ian G. ^{[10
,11
,12
]}

Carson, Andrew ^{[13
]}

Smyth, Mike ^{[1
,13
]}

Han, Kyee ^{[14
]}

Byers, Sonia ^{[14
]}

Rees, Nigel ^{[15
]}

Whitfield, Richard ^{[15
]}

Moore, Fionna ^{[16
]}

Fothergill, Rachael ^{[1
,16
]}

Stallard, Nigel ^{[17
]}

Long, John ^{[1
]}

Hennings, Susie ^{[1
]}

Horton, Jessica ^{[1
]}

Kaye, Charlotte ^{[1
]}

Gates, Simon ^{[1
]}

机构：

[1] Univ Warwick, Warwick Clin Trials Unit, Coventry CV4 7AL, W Midlands, England

[2] Heart England NHS Fdn Trust, Birmingham B9 5SS, W Midlands, England

[3] Kingston Univ London, Fac Hlth Social Care & Educ, London SW17 0RE, England

[4] St Georges Univ London, London SW17 0RE, England

[5] Southampton Univ Hosp, Resp BRU, Southampton SO16 6YD, Hants, England

[6] South Cent Ambulance Serv NHS Fdn Trust, Otterbourne, England

[7] Univ Bristol, Sch Clin Sci, Bristol BS8 1TH, Avon, England

[8] Royal United Hosp, Dept Anaesthesia & Intens Care Med, Bath BA1 3NG, Avon, England

[9] Univ Oxford, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, John Radcliffe Hosp, Kadoorie Ctr Crit Care Res & Educ, Oxford OX3 9DU, England

[10] Monash Univ, Sch Publ Hlth & Prevent Med, Dept Epidemiol & Prevent Med, Melbourne, Vic, Australia

[11] Curtin Univ, Sch Nursing Midwifery & Paramed, PRECRU, Perth, WA, Australia

[12] St John Ambulance Western Australia, Belmont, MA, Australia

[13] West Midlands Ambulance Serv NHS Fdn Trust, Brierley Hill DY5 1LX, England

[14] North East Ambulance Serv NHS Fdn Trust, Newcastle Upon Tyne NE15 8NY, Tyne & Wear, England

[15] Welsh Ambulance Serv NHS Trust, St Asaph LL17 0RS, Denbigh, Wales

[16] London Ambulance Serv NHS Trust, 8-20 Pocock St, London SE1 0BW, England

[17] Univ Warwick, Warwick Med Sch, Stat & Epidemiol, Coventry CV4 7AL, W Midlands, England

来源：

RESUSCITATION | 2016年 / 108卷

基金：

美国国家卫生研究院;

关键词：

Adrenaline; Cardiac arrest; Randomised controlled trial; Vasopressor; CARDIOVASCULAR CARE SCIENCE; CARDIOPULMONARY-RESUSCITATION; TREATMENT RECOMMENDATIONS; INTERNATIONAL CONSENSUS; EPINEPHRINE; OUTCOMES; COMPRESSION; SURVIVAL;

D O I：

10.1016/j.resuscitation.2016.08.029

中图分类号：

R4 [临床医学];

学科分类号：

1002 ; 100602 ;

摘要：

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 and 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). (C) 2016 The Author(s). Published by Elsevier Ireland Ltd.

引用

页码：75 / 81

页数：7

共 27 条

[1] CARDIAC RESUSCITATION Epinephrine to treat cardiac arrest-a double-edged sword [J].