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Home > Topics > Medical / Clinical
August 13, 2014

Medics to give cardiac arrest patients a placebo in controversial trial

Patients whose hearts stop will be given salt water instead of adrenalin in an "ethically questionable" study to see whether adrenalin works in resuscitation

The Telegraph

ENGLAND — 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.

Read full story: Heart patients to be given placebo by paramedics in controversial trial

Comments
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Tracy Villanueva Tracy Villanueva Wednesday, August 13, 2014 6:11:12 PM http://jama.jamanetwork.com/article.aspx?articleid=1105081
David Gonzalez David Gonzalez Thursday, August 14, 2014 7:27:31 AM hola soy paramédico de urgencias medicas nosotros utilizamos la epinefrina para tratar paras cardiaco y es muy efectiva
David Gonzalez David Gonzalez Thursday, August 14, 2014 7:28:17 AM expliquen en que consiste el placebo y que efectos tiene en un px con pcs
David Ferris David Ferris Thursday, August 14, 2014 9:38:32 AM This is insane. A giant step backwards to ethics in our profession.
Adam Williamson Adam Williamson Thursday, August 14, 2014 3:21:40 PM I thought better of ems1 than to copy and paste a story spelling mistake and all. Oh well
Daniel Koskenmaki Daniel Koskenmaki Thursday, August 14, 2014 5:19:23 PM Why is this unethical? We have no substantial evidence to support that adrenalin actually does any better for long-term survival than not giving anything. The only thing we do that we have evidence to back up is compressions. That's it.
Lee Thetford Lee Thetford Thursday, August 14, 2014 8:53:24 PM So my question is... is this study simply placing containers of normal saline labeled "Epi" on ambulances? what if I need epi to treat anaphylaxis? how are they keeping it separate from real Epi and making sure there are no mixups?
Lachlan Conmee Lachlan Conmee Friday, August 15, 2014 4:39:14 AM The crews will have specific packs for each time a patient meets criteria to be opted into the trial. The pack will contain the unmarked medication, thats how most double blind trials go Im pretty sure.
Jay Conner Jay Conner Friday, August 15, 2014 4:41:21 AM it's probably a special kit that remains unopened with unlabeled syringes in it, and is only used if the pt meets the criteria, and they'll still have the labeled drugs required for any other intervention. As far as your anyphylaxis concern, unless they're mixing their own 1:10000 Epi from the 1:1000, it's two entirely different vials
Ken Maston Ken Maston Friday, August 15, 2014 6:42:28 AM Lidocaine went from standard treatment to "unclassified" in 2002 over exactly these kinds of ethical testing concerns. This kind of test was disallowed for lidocaine. If we very carefully screen patients and test, we may improve care. I wonder if the prehispital environment is the best arena to test this, but will always support improvement in care.
Darin Ruud Darin Ruud Friday, August 15, 2014 7:12:34 AM I am excited to see this. I am of the understanding a similar study had to be stopped a few years back due to "public outcry". I have serious personal doubts that this drug is of benefit in anything but short-term outcomes and is probably detrimental in long-term outcomes.
Valerie Frank Serao Valerie Frank Serao Friday, August 15, 2014 9:05:03 AM You don't do human trials on a population that has not consented to participate. End of story!
Daniel Koskenmaki Daniel Koskenmaki Friday, August 15, 2014 12:23:36 PM Are you serious? When there's no evidence to back it up, we can't say that what we're doing is considered best practice. The _only_ way to get evidence is by doing trials. This is completely ethical because: It's treatment for a condition, that, by definition, you cannot get consent for. "Excuse me, sir, I know you're in cardiac arrest right now, but is it alright if I go ahead and use you to test whether or not our medication even works?". Or worse yet, "Since I can't get permission, I'll just go ahead use this drug that I don't have any evidence that it makes any difference" I must disagree. There is no "end of story" when it comes to things like this. When we don't have evidence to support what we are doing, we must get it. The population in question cannot consent to it, and will never be able to. If we continue to provide the same care without changing due to lack of consent (on a condition for which consent for treatment cannot exist), then the standard of care never changes To me, it seems far more unethical to continue to treat with something that we have no evidence of efficacy, than it is to use that same patient in order to make sure our treatment makes a difference. I want to be able to KNOW that what I'm doing is research-based, instead of guessing that it might work, because some doctors are guessing that it might work. Are you familiar with the ALPS study that's currently being done? This is no different.
Deborah Maston Coffey Deborah Maston Coffey Friday, August 15, 2014 3:24:32 PM how would a cardiac arrest patient know placebo vs real thing? I understand using placebo for other stuff, but this seems a little dicey.
Ken Maston Ken Maston Saturday, August 16, 2014 10:03:29 AM I don't think it would be appropriate to do this in the chaos of the prehospital seeing, but I do think we need to take a hard look at everything we do. Construction the arteries in a heart that's already hypoxic is counterintuitive. Well designed questions asked of patients anticipating arrest might be the better way to go. Anybody remember Isuprel?
Kenneth E Smith Kenneth E Smith Saturday, August 16, 2014 2:06:01 PM Why don't they do a pig study?

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