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

Gavin D Perkins; Tom Quinn; Charles D Deakin; Jerry P Nolan; Ranjit Lall; Anne-Marie Slowther; Matthew Cooke; Sarah E Lamb; Stavros Petrou; Felix Achana; Judith Finn; Ian G Jacobs; Andrew Carson; Mike Smyth; Kyee Han; Sonia Byers; Nigel Rees; Richard Whitfield; Fionna Moore; Rachael Fothergill; Nigel Stallard; John Long; Susie Hennings; Jessica Horton; Charlotte Kaye; Simon Gates

doi:10.1016/j.resuscitation.2016.08.029

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

Resuscitation. 2016 Nov:108:75-81. doi: 10.1016/j.resuscitation.2016.08.029. Epub 2016 Sep 17.

Authors

Gavin D Perkins¹, Tom Quinn², Charles D Deakin³, Jerry P Nolan⁴, Ranjit Lall⁵, Anne-Marie Slowther⁵, Matthew Cooke⁶, Sarah E Lamb⁷, Stavros Petrou⁵, Felix Achana⁵, Judith Finn⁸, Ian G Jacobs⁸, Andrew Carson⁹, Mike Smyth¹⁰, Kyee Han¹¹, Sonia Byers¹¹, Nigel Rees¹², Richard Whitfield¹², Fionna Moore¹³, Rachael Fothergill¹⁴, Nigel Stallard¹⁵, John Long⁵, Susie Hennings⁵, Jessica Horton⁵, Charlotte Kaye⁵, Simon Gates⁵

Affiliations

¹ Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK; Heart of England NHS Foundation Trust, Bordesley Green East, Birmingham B9 5SS, UK. Electronic address: g.d.perkins@warwick.ac.uk.
² Faculty of Health, Social Care and Education, Kingston University London and St. George's, University of London, London SW17 0RE, UK.
³ Respiratory BRU, University Hospital Southampton SO16 6YD, UK; South Central Ambulance Service NHS Foundation Trust, Otterbourne, UK.
⁴ School of Clinical Sciences, University of Bristol, Bristol BS8 1TH, UK; Department of Anaesthesia and Intensive Care Medicine, Royal United Hospital, Bath BA1 3NG, UK.
⁵ Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK.
⁶ Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK; Heart of England NHS Foundation Trust, Bordesley Green East, Birmingham B9 5SS, UK.
⁷ Kadoorie Centre for Critical Care Research and Education, John Radcliffe Hospital, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 9DU, UK.
⁸ Department of Epidemiology and Preventive Medicine, School of Public Health & Preventive Medicine, Monash University, Melbourne, Australia; Prehospital, Resuscitation and Emergency Care Research Unit (PRECRU), School of Nursing, Midwifery and Paramedicine, Curtin University, Perth, Australia; St John Ambulance Western Australia, Belmont, Australia.
⁹ West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill DY5 1LX, UK.
¹⁰ Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK; West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill DY5 1LX, UK.
¹¹ North East Ambulance Service NHS Foundation Trust, Newcastle upon Tyne NE15 8NY, UK.
¹² Welsh Ambulance Services NHS Trust, Denbighshire, Wales LL17 0RS, UK.
¹³ London Ambulance Service NHS Trust, 8-20 Pocock Street, London SE1 0BW, UK.
¹⁴ Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK; London Ambulance Service NHS Trust, 8-20 Pocock Street, London SE1 0BW, UK.
¹⁵ Statistics and Epidemiology, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.

PMID: 27650864
PMCID: PMC5081174
DOI: 10.1016/j.resuscitation.2016.08.029

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 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). Trial registration (ISRCTN73485024).

Keywords: Adrenaline; Cardiac arrest; Randomised controlled trial; Vasopressor.

Publication types

Pragmatic Clinical Trial
Research Support, Non-U.S. Gov't

MeSH terms

Cardiopulmonary Resuscitation / methods*
Clinical Protocols
Double-Blind Method
Emergency Medical Services / statistics & numerical data*
Emergency Medical Technicians
Epinephrine / therapeutic use*
Humans
Out-of-Hospital Cardiac Arrest / drug therapy*
Out-of-Hospital Cardiac Arrest / economics
Out-of-Hospital Cardiac Arrest / mortality
Pilot Projects
Randomized Controlled Trials as Topic
Survival Analysis
Survivors / statistics & numerical data
Treatment Outcome
Vasoconstrictor Agents / therapeutic use*

Substances

Vasoconstrictor Agents
Epinephrine

Abstract

Publication types

MeSH terms

Substances

Grants and funding