Medics Give Placebo in Questionable Cardiac Arrest Study on Adrenalin

Warwick University study will look at the possibility of brain damage


 
 

American Heart Association | | Thursday, August 28, 2014


Paramedics will give patients whose heart has stopped a dummy drug as part of an 'ethically questionable' study into whether adrenalin works in resuscitation or not, it has emerged.

Patients in cardiac arrest will receive either a shot of adrenalin, which is the current practice, or a salt water placebo but the patient, their relatives nor the paramedic administering it will know which.

The trial is seen to be controversial because patients will not be able to consent to taking part and could receive a totally useless placebo injection.

Current guidelines used by UK ambulance services recommend routinely giving adrenalin during the resuscitation of patients who have suffered cardiac arrest.

However, there are concerns that adrenalin may cause severe brain damage and may not help overall survival at all.

The new study, led by Warwick University, has been approved by an ethics committee and will begin in the autumn in Wales, London, the South coast, North East and West Midlands.

The first 8,000 patients who suffer a cardiac arrest will be included.

Dr Martin Underwood, whose team at Warwick University are running the study, said there will be local advertising campaigns before the study begins and people will be able to opt out in advance.

However he acknowledged that few were likely to do so and that the logistics of checking the identity and wishes of patients during frantic attempts to save their lives would be difficult.

He stressed that all other resuscitation including heart massage and defibrillation would be conducted on all patients as normal.

"We do not know that adrenalin does improve survival," he said. "It is possible that it improves short-term survival but few patients leave hospital and it may be at the cost of neurological damage.

"It may in fact be something that is custom and practice that is actually harming people.

"There are sufficient grounds for concern that what we are doing at the moment is detrimental to people."

He said the data would be reviewed at regular intervals throughout the trial and if it was clear that the dummy group or the adrenalin group was doing better than the study would be stopped.

Dr Underwood said: "We wouldn't expect people would be put at unnecessary risk by this."

There are thought to be around 50,000 people in Britain who suffer a cardiac arrest outside of hospitals, with just six per cent surviving and fewer still have no lasting brain damage.

Adrenalin has been used in resuscitation since the 1960s, before randomised controlled trials were conducted, Mr Underwood said.

The study, titled Paramedic 2: the adrenalin trial, is being supported by the Resuscitation Council and there have been calls for urgent studies into the use of adrenalin by the International Liaison Committee for Resuscitation (ILCOR).

It will seek to answer whether the use of adrenalin in such cases is clinically and cost effective and is being funded by the National Institute of Health Research (NIHR) at a cost of more than £2.75m.

Professor Gavin Perkins, who is one of those leading the trial, said: “The need to do this research is underpinned by a serious concern that although using adrenalin might help restart the heart in the short term, it causes severe brain damage leading to death a few hours or days later.

“We want the best possible outcomes for all people who have a cardiac arrest, both now and in the future.

“All patients will receive the treatment that is proven to improve survival from cardiac arrest, CPR and defibrillation.

"Adrenalin is an unproven treatment for cardiac arrest and may be harmful, which is why there is a need for this study.”

Initial resuscitation is effective in roughly just one in four heart attack patients but half of those who survive die in intensive care due to brain damage, which experts believe could be worsened by adrenalin.

But relatives of patients who may die having taken part in the trial will not automatically be made aware of their involvement in the study.

Dr David Hunter, Professor of Medical Ethics at Flinders University in Adelaide, worked at the Centre for Professional Ethics at Keele University until 2011 and believes the study is “probably ethically justifiable – although ethically challenging because of the potential for harms to those who can't consent to them”.

However Dr Hunter has raised concerns.

He said: “I'm not that keen on using passive means to inform relatives that their now deceased loved ones were part of a trial.

“While there are costs and indeed risks as they note in doing this directly the risks are incurred by doing it indirectly and I think it's a matter of respect that you inform people.

“Also it isn't clear if you can opt out – it says 'patients can opt out' in a similar fashion to opting out of resuscitation – I assume this only applies to present patients, so a small subset of the possible trial population.”

The passive measures to be used to inform relatives involve placing information about the trial in publicly accessible places, rather than directly informing relatives of patients involved in the study.

Other academics who support the trial have raised queries about consent and concerns that families of the dead will have to seek information about the study themselves.

Professor Paul Kinnersley is a GP and chairman of Cardiff University's Institute of Primary Care and Public Health, who also represents Wales as part of the Institute for Medical Ethics. He supports the study despite outlining some ethical risks.

He said: “Obviously you can't get consent for everyone who is going to to have a cardiac arrest but there's an ethical duty to do the trial.”

Professor Kinnersley said families should be informed carefully, but not passively, to avoid adding to grief and believes NHS staff and the research academics should not be defensive when doing so.

He said: “There is a risk of compensation claims but ambulance trusts need to cope with that and explain the trial and be positive about why they're doing it.”

A spokesman for the NIHR said the ethics application that has been approved could not be made public due to commercial interests, but Professor Perkins defended the ethics of the trial.

He said: “It is not possible to obtain consent in the immediate emergency situation. A member of the research team will seek consent to continue in the study as soon as possible once the initial emergency has passed.

“People who do not want to be part of the trial may opt out in advance by contacting their local ambulance service.

“Information about the study will be available from local ambulance services once the trial starts and families will be able to contact the ambulance service or the study team to discuss any concerns and seek further information and support.”

Dr Jasmeet Soar, Consultant in Intensive Care Medicine & Anaesthetics and former Chair of the Resuscitation Council (UK), defended including the cost-effectiveness of adrenalin as part of the study.

She said: “The findings of this study will provide greater understanding of the role of adrenalin for the treatment of cardiac arrest, and help inform future advanced life support guidelines.

“Cost-effectiveness of an intervention is an important part of any study, although adrenalin itself is relatively inexpensive, its use may decrease, or increase costs due to unnecessary complications that could be avoided by not using it.

“We simply do not know, and a study of this size will help answer what costs are associated with the use of adrenalin. Indeed economic analyses help direct funds to those interventions that offer the best chance of survival.”

The Welsh Ambulance Service NHS Trust, the London Ambulance Service, the West Midlands Ambulance Service NHS Trust, the North East Ambulance Service NHS Foundation Trust and the South Central Ambulance Service NHS Foundation Trust will be taking part in the trial.

Paramedics and clinicians will be blind to whether they are administering adrenalin or placebo.

Nigel Rees, Senior Research Lead at the Welsh Ambulance Service, said: “Given the uncertainty of the evidence and the life-threatening nature of the condition being treated, it is important that we obtain the best evidence we can to provide the best treatment possible.

“When doctors, nurses and paramedics do not know whether a treatment is effective it is common to undertake a research study.

“We will always endeavour to act in the best interests of our patients, their safety of which is paramount.”

The trial was due to begin in March this year, running until 2016, but a spokesperson for the University of Warwick said it is now due to begin in the autumn.

For more information please visit: http://www.heart.org
August 27, 2014

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