Bioethics Blogs

“Please randomize me – but don’t tell my family that you did”

Last week various newspapers (see here and here) reported on a planned research study of adrenaline for patients suffering a cardiac arrest outside hospital. The PARAMEDIC 2 trial (full protocol here) involves ambulance officers randomly giving patients either the traditional resuscitation drug adrenaline, or a salt-water solution (placebo). The trial has been strongly criticized by Ruth and Lindsay Stirton, writing in the Journal of Medical Ethics.

There are two main controversial elements to the trial design. The first involves the lack of consent for involvement in the trial, the second involves the researchers’ plan not to inform families of patients who died that their loved one had been in a research trial.

First, it is important to appreciate the context of this trial. 50,000 people in the UK each year have a cardiac arrest outside hospital. Contrary to public perception, the chance of survival if this happens is extremely low – less than one in ten patients leave hospital alive. Adrenaline is a naturally occurring stress hormone that has been used for a long time for patients whose hearts have stopped. But there is actually very little good evidence that adrenaline is helpful in this situation. There has only been one relatively small trial, which didn’t show a definite benefit. And there is some reason to think that adrenaline may be harmful. Very large studies (not randomized trials) that compared patients who had received adrenaline to those who had not received adrenaline suggest that adrenaline may increase the chance of patients’ hearts being restarted.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.