# Is Oregon study still on (prehospital cardiac drugs)?



## mycrofft (Mar 7, 2013)

Somehwere we have a thread about this but it doesn't turn up for me.
http://www.oregonlive.com/health/index.ssf/2012/07/emergency_care_study_in_portla.html
This turned up in GOOGLE using words "Oregon paramedic placebo"


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## mycrofft (Mar 7, 2013)

*Related article, study about haemorrhagioc shock*

http://www.ohsu.edu/xd/about/news_events/news/2012/07-23-informed-consent-expcept.cfm
Also without express consent


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## medicsb (Mar 7, 2013)

Look up resuscitation outcomes consortium, that is what OHSU is taking part in.


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## mycrofft (Mar 7, 2013)

Did that. It's  three year study, no report yet. No apparent news articles either, like "Study Halted".


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## Luno (Mar 7, 2013)

You're looking for the ALPs study, and I don't know about OR, but it is still being run by the ROC at least as of a couple of months ago.


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## medicsb (Mar 7, 2013)

C'mon, google!

http://www.ohsu.edu/emergency/research/roc/


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## mycrofft (Mar 7, 2013)

I read three articles. I was curious if it had been cancelled yet. We have members working up there.


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## medicsb (Mar 7, 2013)

What makes you think it will be cancelled?


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## Dwindlin (Mar 7, 2013)

medicsb said:


> What makes you think it will be cancelled?



Honestly I'm surprised it made through an IRB. . .


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## EpiEMS (Mar 7, 2013)

Dwindlin said:


> Honestly I'm surprised it made through an IRB. . .



Why's that?


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## Dwindlin (Mar 7, 2013)

EpiEMS said:


> Why's that?



Full disclosure I haven't seen anything that shows the actual protocol for the study.  But it's a placebo study, if it were just Amio/Lido no problem, but I'm surprised an IRB let it go through with a placebo arm. :censored::censored::censored::censored: the IRB's here throw a fit over minor :censored::censored::censored::censored: when a placebo is involved...I can't imagine the strokes I would cause if I tried to put forth a placebo trial involving cardiac arrest patients.


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## mycrofft (Mar 7, 2013)

I visit up there and I'm getting another tag for my medical alert that says no placebos.


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## EpiEMS (Mar 7, 2013)

Dwindlin said:


> Full disclosure I haven't seen anything that shows the actual protocol for the study.  But it's a placebo study, if it were just Amio/Lido no problem, but I'm surprised an IRB let it go through with a placebo arm. :censored::censored::censored::censored: the IRB's here throw a fit over minor :censored::censored::censored::censored: when a placebo is involved...I can't imagine the strokes I would cause if I tried to put forth a placebo trial involving cardiac arrest patients.



I was gonna say. But then again, most of the ACLS drugs really do show no benefit, at least, so says Rogue Medic (and the ACLS guidelines, frankly).


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## Dwindlin (Mar 7, 2013)

EpiEMS said:


> I was gonna say. But then again, most of the ACLS drugs really do show no benefit, at least, so says Rogue Medic (and the ACLS guidelines, frankly).



Absolutely agree with you, but IRBs (in my experience anyways) are hyper-sensitive to ethical/libility issues.  Valid or not, giving a placebo to a victim of cardiac arrest could open a HUGE can of worms from an ethical/liability stand point.


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## kindofafireguy (Mar 7, 2013)

Dwindlin said:


> Absolutely agree with you, but IRBs (in my experience anyways) are hyper-sensitive to ethical/libility issues.  Valid or not, giving a placebo to a victim of cardiac arrest could open a HUGE can of worms from an ethical/liability stand point.



True, but then you can also raise the question of the ethics of pushing drugs that have actually shown a decrease in successful outcomes.

It all comes down to perception...


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## medicsb (Mar 7, 2013)

The concept to understand is clinical equipoise.  It's, like, humungous when it comes to ACLS.  Given the available data, it is UNETHICAL to use almost any drug in cardiac arrest outside of a clinical trial at this point.


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## Dwindlin (Mar 8, 2013)

kindofafireguy said:


> True, but then you can also raise the question of the ethics of pushing drugs that have actually shown a decrease in successful outcomes.
> 
> It all comes down to perception...





medicsb said:


> The concept to understand is clinical equipoise.  It's, like, humungous when it comes to ACLS.  Given the available data, it is UNETHICAL to use almost any drug in cardiac arrest outside of a clinical trial at this point.



Apparently you all work with more receptive IRBs than I do. . .


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## kindofafireguy (Mar 8, 2013)

Dwindlin said:


> Apparently you all work with more receptive IRBs than I do. . .



Oh I just said you could raise the question. Never said it would work.


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## EpiEMS (Mar 8, 2013)

medicsb said:


> The concept to understand is clinical equipoise.  It's, like, humungous when it comes to ACLS.  Given the available data, it is UNETHICAL to use almost any drug in cardiac arrest outside of a clinical trial at this point.



Hear, hear!


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## jkc (Mar 9, 2013)

medicsb said:


> The concept to understand is clinical equipoise.  It's, like, humungous when it comes to ACLS.  Given the available data, it is UNETHICAL to use almost any drug in cardiac arrest outside of a clinical trial at this point.



ALPS is still going strong. Our service (up in Canada) is about to start enrolling patients any day now, and several neighbouring services are on board as well.

As for ethical or legal approval, I think the uncertainty here points to the real problem: we don't have ANY evidence to show our standard of care (amio/lidocaine) has ANY survival benefit. Is the problem with a placebo, or IRBs, or that we can't show that what we do is helpful?


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## mycrofft (Mar 9, 2013)

If a drug is found to be ineffective or harmful, it needs to be discontinued at once. 

If it isn't, you use it.

If it isn't and you use it normally but you start giving a blind test between a drug that you use and presumably works and a known placebo (saline), you are randomly withholding treatment. Your index of suspicion that the older drugs don't work has to be pretty high to do that. 

Damned if you do, and vice versa.


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## jkc (Mar 11, 2013)

mycrofft said:


> If a drug is found to be ineffective or harmful, it needs to be discontinued at once.



Amiodarone and lidocaine, according to the best evidence available, are ineffective in changing any important outcome, like survival to discharge or neurologically intact survival. Yet we still use them... 
Seems like ALPs is answering an important question.

_____

Harrison EE. Lidocaine in prehospital countershock refractory ventricular fibrillation. Ann Emerg Med 1981;10:420-423. (Retrospective; 116 patients)

Weaver WD, Fahrenbruch CE, Johnson DD, et al. Effect of epinephrine and lidocaine therapy on outcome after cardiac arrest due to ventricular fibrillation. Circulation 1990;82:2027-2034. (Unblinded, randomized; 199 patients)

Herlitz J, Ekstrom L, Wennerblom B, et al. Lidocaine in out-of-hospital ventricular fibrillation. Does it improve survival? Resuscitation 1997;33:199-205. (Retrospective cohort; 1212 patients)

Dorian P, Cass D, Schwartz B, et al. Amiodarone as compared with lidocaine for shock-resistant ventricular fibrillation. N Engl J Med 2002;346:884-890. (Randomized, double-blind; 347 patients)

via Evidence Based Medicine (Unfortunately I don't have enough posts to give the link, but it will show up with a quick google search for ebmedicine. Try to ignore all the paid subscription stuff.)


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## Christopher (Mar 11, 2013)

jkc said:


> Amiodarone and lidocaine, according to the best evidence available, are ineffective in changing any important outcome, like survival to discharge or neurologically intact survival. Yet we still use them...
> Seems like ALPs is answering an important question.



We've always known that though...amiodarone is poorly effective at terminating ventricular arrhythmias OF ALL CAUSES...lidocaine is poorly effective at terminating ventricular arrhythmias OF ALL CAUSES. For many specific types of ventricular arrhythmias they work great. Lidocaine is wonderful for ischemia induced VT. (Wait...you mean there are different types of VT besides monomorphic and polymorphic?!)

It is not surprising that throwing a blanket medication at patients would result in rates not statistically different from placebo.


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## fast65 (Mar 11, 2013)

Someone was talking to me about this study not too long ago at a conference I attended. I'm pretty sure our mother company is part of this study as well, but I'll have to ask around...


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## Madmedic780 (Apr 4, 2013)

So yeah study, it was a :censored::censored::censored::censored: show when were told that we were doing it. 

However frankly in my neck of the woods our ROSC rate is pretty low due to response time due to the rural aspect (esp in Clackamas County). Overall I'm not super opposed to it. If anyone has specific questions I can try to address them.


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## Madmedic780 (Apr 4, 2013)

Christopher said:


> It is not surprising that throwing a blanket medication at patients would result in rates not statistically different from placebo.



I'm willing to bet this is what they are aiming to discover.


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## Christopher (Apr 4, 2013)

Silverman780 said:


> So yeah study, it was a :censored::censored::censored::censored: show when were told that we were doing it.
> 
> However frankly in my neck of the woods our ROSC rate is pretty low due to response time due to the rural aspect (esp in Clackamas County). Overall I'm not super opposed to it. If anyone has specific questions I can try to address them.



Why would anybody be opposed to this study? Or was the fuster cluck getting folks to use the study-kits? Or something else I've missed.


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## mycrofft (Apr 4, 2013)

When I visit Clackamas and Portland I carry a card refusing the study.
(Go Molalla! No, I mean it....GO).


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## rmabrey (Apr 24, 2013)

fast65 said:


> Someone was talking to me about this study not too long ago at a conference I attended. I'm pretty sure our mother company is part of this study as well, but I'll have to ask around...



IIRC where you work I would say that is a good possibility. My shop already has a draft protocol for removing EPI from cardiac arrest. I don't know when it goes into effect but it will be soon.


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## medicsb (Apr 24, 2013)

rmabrey said:


> IIRC where you work I would say that is a good possibility. My shop already has a draft protocol for removing EPI from cardiac arrest. I don't know when it goes into effect but it will be soon.



Let us know if or when it occurs.  Also, that would be a prime opportunity for a "before and after" study, or to reintroduce epi as a double blind placebo-controlled trial.  (I won't hold me breath, though.)


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## rmabrey (Apr 25, 2013)

medicsb said:


> Let us know if or when it occurs.  Also, that would be a prime opportunity for a "before and after" study, or to reintroduce epi as a double blind placebo-controlled trial.  (I won't hold me breath, though.)



I'm sure a study will happen. Our medical director and QI are very evidence based.  We were one of the first to increase response time to prove no change in outcomes. if that gives you any idea how we roll here


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## mycrofft (Apr 25, 2013)

rmabrey said:


> I'm sure a study will happen. Our medical director and QI are very evidence based.  We were one of the first to increase response time to prove no change in outcomes. if that gives you any idea how we roll here



*Hold the presses. There is an important thread there. Any article, reports etc to cite? Start a thread rmabrey!*


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## rmabrey (Apr 25, 2013)

mycrofft said:


> *Hold the presses. There is an important thread there. Any article, reports etc to cite? Start a thread rmabrey!*



I could ask if there was anything. But I think this was mostly an in house thing over a few years for contract stuff. I know there was a presentation on a similiar study at the Houston conference this year. 

Im sure as large as my company is there is something floating around.


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