Furosemide is good for filling the patient’s bladder, but the patient probably did not call for help filling his/her bladder.

- Rogue Medic

What should an epinephrine in cardiac arrest study look like?

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Since the Hagihara[1] study was published, there is a lot more support for a study of epinephrine. One of the problems with studying epinephrine is the religious devotion that some have to maintaining the status quo.

How do we prevent paramedics from violating the study protocol?

I have been told of paramedics testing the study drug to see if it produces the cocaine-type of numbness to the tongue, since epinephrine produces effects similar to cocaine without the euphoria. If the study drug is not epinephrine, the syringe is broken, or replaced, or . . . .

How much epinephrine is needed on an ALS (Advanced Life Support) ambulance?

We generally carry a bunch of 1:10,000 epinephrine (1 mg in 10 ml) for cardiac arrest. Maybe 5 – 10 with a multi-dose 30 ml vial of 1:1,000 (1 mg in 1 ml) epinephrine for those prolonged arrests, so that 1 mg at a time can be drawn up and given to the patient.

We also carry some ampules of 1:1,000 epinephrine for IM (IntraMuscular), SC (SubCutaneous), or IV (IntraVenous) administration for anaphylaxis or asthma.

We can easily replace the 1:10,000 epinephrine and the multi-dose vial with just one study drug packet. After each code, a new packet would be placed in the ambulance’s drug bag/box. This would discourage the tendency to switch kits if the study drug is not epinephrine – not that there is any good reason for the medic to know what is being given.

For anaphylaxis/asthma, participating ambulances would be assigned only autoinjectors. This would decrease the availability of epinephrine available to violate protocol.

Supervisors would only carry study kits and autoinjectors.

Is it still possible to intentionally violate protocol? Yes, but anyone thinking that far ahead should be smart enough to realize that they are only harming patients by possibly requiring that the study be repeated. The maturity of the medics should be the best protection against protocol violation, but true believers can be immune to maturity.

What would the study kits include?

The RAMPART[2], [3] study gives an excellent example of how to

Patients are not entered into the study unless they have reached the point in the algorithm where epinephrine would be given. When the kit is opened, the recording beginsand the first syringe of the study drug is given.

Monitors capable of recording the quality of CPR would also be used. The ROC (Resuscitation Outcomes Consortium) should already be using these, so it would not be an added expense.

What about patients who remain in a shockable rhythm after the syringes of study drug are all used? Transport them to the hospital. Let the hospital do whatever they want with these rare patients.

What if there is a problem with the study kit? Then the patient should not be receiving any medication and should be unblinded participants in the group not receiving epinephrine.

What about amiodarone/lidocaine? There is no good reason to give these derivative magic treatments until there is evidence that they work. This is to try to find out if the primary magic treatment epinephrine works, not to support the whole Chain of Magic.

Maybe the last part of that chain should not be there.

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See also –

How to Study Epinephrine in Cardiac Arrest

Images from Gathering of Eagles Presentation on RAMPART

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Footnotes:

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[1] Prehospital epinephrine use and survival among patients with out-of-hospital cardiac arrest.
Hagihara A, Hasegawa M, Abe T, Nagata T, Wakata Y, Miyazaki S.
JAMA. 2012 Mar 21;307(11):1161-8. doi: 10.1001/jama.2012.294.
PMID: 22436956 [PubMed - indexed for MEDLINE]

Free Full Text from JAMA.

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[2] Epileptic Fix: Hot-Off-the-Press Results from the RAMPART Trial
Jason T. McMullan, MD (Cincinnati)
Gathering of Eagles
Friday, February 24, 2012
Presentation

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[3] Intramuscular versus intravenous therapy for prehospital status epilepticus.
Silbergleit R, Durkalski V, Lowenstein D, Conwit R, Pancioli A, Palesch Y, Barsan W; NETT Investigators.
N Engl J Med. 2012 Feb 16;366(7):591-600.
PMID: 22335736 [PubMed - in process]

Free Full Text from N Engl J Med.

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Comments

  1. The thought that Paramedics would intentionally violate a study protocol makes me physically ill. I am lost for words to describe the does-not-compute-ness of this.

    For international comparison down under adrenaline is carried as 1mg in 1ml ampoules and all adrenaline is drawn out an ampoule; no auto injectors are carried.

    And as for transporting a patient to the hospital who is in cardiac arrest, that’s just continuing that chain of magic … nothing the hospital can do that the ambo’s can’t do out in the field.

    • Ben,

      The thought that Paramedics would intentionally violate a study protocol makes me physically ill. I am lost for words to describe the does-not-compute-ness of this.

      There are people who are so sure that they know the truth, that they believe they are protecting patients from bad outcomes. They are true believers. This arrogance of ignorance is beyond scary.

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      For international comparison down under adrenaline is carried as 1mg in 1ml ampoules and all adrenaline is drawn out an ampoule; no auto injectors are carried.

      We carry epinephrine (adrenaline) for anaphylaxis the same way. My idea is to make it so that there is no other way of obtaining epinephrine to use in cardiac arrest. This would be just for the duration of the study, unless the price came down dramatically. Auto-injectors are nice and practical, but may not be the best way to treat anaphylaxis.

      What About IV Epinephrine for Patients Who Are Not Dead

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      And as for transporting a patient to the hospital who is in cardiac arrest, that’s just continuing that chain of magic … nothing the hospital can do that the ambo’s can’t do out in the field.

      As with the auto-injectors, this would just be for the duration of the study, to satisfy those afraid that the patients would be deprived of epinephrine.

      .

  2. Maybe the last part of that chain should not be there.

    Sometimes your facetiousness gets a little bit out of control, don’t you think? ;-)

    Seriously – what your describing is a basic double-blind study model, right? Because in principle it should work. The issue with deviation, as you said, is going to be with those crews who either think they know better than anyone else. Because of that, they won’t want to participate because they are, as you put it, “true believers.”

    Are you familiar with the study done in Australia? If you haven’t seen it, here is the reference:

    Jacobs, I., Finn, J., Jelinek, G., Oxer, H., & Thompson, P. (2011). Effect of adrenaline on survival in out-of-hospital cardiac arrest: a randomised double-blind placebo-controlled trial. Resuscitation, 82, 1138-1143. doi: 10.1016/j.resuscitation.2011.06.029

    It was one of the first of what should certainly be many of this sort of study, and while it didn’t go according to plan (and what study of any type ever does?), it was reasonably well documented.

    Again – thanks for making me (and many others, I’m sure) think. Because of your influence I’ve managed to piss off some righteous types. And I’m glad I have….

  3. To echo what Ben Hoffman said, I’m horrified that paramedics would tamper with a study such as you described. Though, as someone who has been involved in university research (chemistry, not medicine), it sadly doesn’t surprise me. As one professor told me, “Sometimes science advances when the old scientists die.”

    Hopefully, the number of medics who would be protocol monkey enough to want to push epi regardless, but have be proactive enough to test the “test medication”, would be small. At least, with the voice/data recorders, they wouldn’t be able to do it for long…

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