Is Oregon study still on (prehospital cardiac drugs)?

[Dwindlin]

Originally Posted by EpiEMS

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. the IRB's here throw a fit over minor 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.

[mycrofft]

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

[EpiEMS]

Originally Posted by Dwindlin

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. the IRB's here throw a fit over minor 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).

[Dwindlin]

Originally Posted by EpiEMS

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.

[kindofafireguy]

Originally Posted by Dwindlin

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...

[medicsb]

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.

[Dwindlin]

Originally Posted by kindofafireguy

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...

Originally Posted by medicsb

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. . .

[kindofafireguy]

Originally Posted by Dwindlin

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.

[EpiEMS]

Originally Posted by medicsb

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!

[jkc]

Originally Posted by medicsb

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?