Paramedic 2: Adrenaline Trial

Background

For more than 50 years, adrenaline has been given by healthcare professionals in attempts to revive people who have died unexpectedly. This was recommended practice, although no proof ever existed that it could make recovery more likely. In recent years, many studies have suggested that the practice is not helpful, and may even increase risk. The feeling now is that stopping its routine use may be the right thing to do, but we do not know this for sure.

Only what is called a “randomised trial” can prove this one way or another. Leaders of the major advisory bodies have called for this to be done. The London Ambulance Service is one of five services in the United Kingdom to answer this call; we believe our patients would expect us to play our part in finding out what is safe and what is not.

The PARAMEDIC-2 trial, led by the University of Warwick, aims to improve the outcomes for patients suffering a cardiac arrest outside of the hospital environment.

Of the 30,000 people who have a cardiac arrest each year, national figures show no more than seven per cent survive to hospital discharge.


How the trial will work

The International Liaison Committee on Resuscitation, European Resuscitation Council and Resuscitation Council (UK) which set the current resuscitation guidelines, have identified the urgent need for a clinical trial to look at whether current adrenaline therapy is safe and effective.

The only way to do this is by a type of research study called a randomised controlled trial comparing adrenaline with a placebo (saline), in which neither the clinician nor the patient is aware of the group into which the patient has been randomised.

Adult patients, who suffer cardiac arrest, and where advanced life support is given, are eligible for the study.

Those who are pregnant, those who have gone into cardiac arrest caused by anaphylaxis or life-threatening asthma, or where adrenaline has been given prior to ambulance arrival will not be enrolled in the trial.

Clinicians are supplied with a pack of trial drugs (this will either be adrenaline or placebo but labeled as ‘trial drug’), which is used in place of standard adrenaline syringes.

These patients will be monitored in hospital and the study investigators will compare what happens to the patients who received adrenaline and those who received placebo.
In London, the trial is now live across West, North West, and North Central London.

The trial will finish in 2018.

How to decline participation in the study

Members of the public who do not wish to be enrolled in the trial can choose to decline participation by requesting a stainless steel bracelet, which has the words ‘no study’ engraved on it, from the University of Warwick website either through an online form or emailing or phoning the trial team.

Medics will be trained to look for these bracelets in the same way they do for other medical ID bands. This means that, in the event that someone has a cardiac arrest, they will receive standard treatment which may include adrenaline.

More information

This project is funded by the National Institute for Health Research’s Health Technology Assessment programme (project number 12/127/126) and co-ordinated by the University of Warwick, has received Research Ethics Committee approval and Medicines & Healthcare products Regulatory Authority (MHRA) approval.

For more information please find a Frequently Asked Questions document please visit the University of Warwick website.

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, NIHR, NHS or the Department of Health.