# Study: RCT of Amiodarone vs. Lidocaine vs. PLACEBO



## medicsb (Jan 28, 2012)

So by 2015ish we should have some idea if an antiarrhythmic given during cardiac arrest actually works.  Sweet.


Follow the link for the full story
http://www.ems1.com/cardiac-care/ar...aluate-CPR-drugs-after-sudden-cardiac-arrest/

Trials start to evaluate CPR, drugs after sudden cardiac arrest
The majority of the approximately 350,000 people who have cardiac arrest in the US each year are assessed by emergency medical service (EMS) providersShare   inShare. 

By the National Institutes of Health's National Heart, Lung, and Blood Institute

BETHESDA, Md. — The National Institutes of Health has launched two multi-site clinical trials to evaluate treatments for out-of-hospital cardiac arrest. One will compare continuous chest compressions (CCC) combined with pause-free rescue breathing to standard cardiopulmonary resuscitation (CPR), which includes a combination of chest compressions and pauses for rescue breathing. 

The other trial will compare treatment with the drug amiodarone, another drug called lidocaine, or neither medication (a salt-water placebo) in participants with shock-resistant ventricular fibrillation, a condition in which the heart beats chaotically instead of pumping blood.

.....


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## WTEngel (Jan 29, 2012)

We already know that amiodarone has been shown to produce higher resuscitation rates. 

Dorian P, Cass D, Schwartz B, Cooper R, Gelaznikas R, Barr A.
Amiodarone as compared with lidocaine for shock-resistant ventricular
fibrillation. N Engl J Med. 2002;346:884–890

I am more interested in the continuous compressions vs. traditional CPR.


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## Veneficus (Jan 29, 2012)

WTEngel said:


> We already know that amiodarone has been shown to produce higher resuscitation rates.
> 
> Dorian P, Cass D, Schwartz B, Cooper R, Gelaznikas R, Barr A.
> Amiodarone as compared with lidocaine for shock-resistant ventricular
> ...



Forgive me, but that specifically states what we knew about ROSC to admission, not to discharge which is now the standard.


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## WTEngel (Jan 29, 2012)

No request for forgiveness necessary...

My assumption was that if amiodarone leads to more admisssions, then by default it would lead to more discharges.

If over 50% of the amiodarone admissions were not surviving to discharge, and 100% of the lidocaine admissions were surviving to discharge, then the discharge rates would be roughly equal. I would be surprised to see values like this though. (this is based on the slightly greater than 20% admission rate of amiodarone compared to the approximately 12% admission rate for lidocaine)

I wonder why they don't look at the data retrospectively and draw conclusions about discharge? I can not tell from the OP article how the studies differ in construction. 

In your experience Vene, which drug has better rates of discharge? I am convinced amiodarone has the upper hand, but we could be seeing different results based on regional practice...


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## Veneficus (Jan 29, 2012)

WTEngel said:


> No request for forgiveness necessary...
> 
> My assumption was that if amiodarone leads to more admisssions, then by default it would lead to more discharges.
> 
> ...



My experience is a bit skewed on the topic since most agencies have used amiodarone for some years now and when lidocaine was the standard, ROSC at the ED was the goal, not discharge so we didn't look any farther.

By the sheer numbers, I have witnessed more success with amio, but like I said, only because once I started looking past the ED nobody was using lido anymore.

But I think this new study is extremely important. We used to give an epi/levofed cocktail for cardiac arrest, and I can tell you with certainty it produces pulses. Unfortunately, that pulse doesn't last past the life of the drug, so all you end up doing with it is admitting to the ICU to donate organs or make a family choose to pull the plug. 

It is possible the antiarrhythmic argument does exactly the same. The latest I have seen is there is no significant difference in discharge between the 2, which supports my opinion.

Just like many pathologies and treatments, the patient has to have enough normal tissue and physiologic reserve remaining in order to recover.

Otherwise, we are just gowing vegetables by manipulating chemical reactions in a water medium. 

At the moment, one of the studies I am involved in is ruptured AAA treatments. Most who survive the operation spend about 30 days in the ICU. The data shows no difference in those who survive to discharge vs. those who don't in terms of length of stay. I think this discussion ois directly comparable.

In my personal opinion, the use of an antiarrhythmic in arrest is probably only effective in those who arrested because of an underlying arrhythmia that caused cardiac hypoperfusion.

I think it is a big mistake to call SCD or SCA, as you like, its own pathology and treat it as such. ~70% of SCD is a result of vfib secondary to an MI. We know in this case electrical therapy can restore a perfusable rhythm, but there may not be enough surviving myocardium to sustain end organ perfusion. 

At current, emergent LVAD is not a common therapy applicable to acute insufficent cardiac output.

You want to impress me treating by the numbers, make tPa a first line agent in SCA and see how that works in a large trial over time. 

In my not always humble opinion, I think resuscitation experts attempting to use ACLS as their guide for resuscitation are going to produce no better results than anyone else (including bystanders with an AED) because the guidlines are based on epidemiology and, like many things in medicine, are consensus. 

It is much easier to create consensus than to be correct.

The case of recurrent vfib, which in not responsive to high dose near sequential defibrillation (which I think would be more effective than amio or lido) you may not have enough surviving myocardial structures or normal cellular physilogy to maintain a rhthym. So in reality what is physically going on may be closer to PEA than a reversible vfib/vtach. (under the caveat the vfib is a complication of MI and not another underlying pathology which would have more specific treatment and likely be more responsive)


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## mycrofft (Jan 29, 2012)

Statistics. Ask Disraeli.

How about making the statistics uniform across the USA and tracking every case from dispatch, which later turns out to be X Y or Z by Dx or postmortem, through d_*ischarge from care*_, not just admission to discharge from hospital. 

IF amiodarone gets more people to the hosp alive, it MAY have more alive to discharge, but if the discharge from hosp numbers are better for another drug, it may be that those patients die before admission (in the field or in the ambulance), thus acting as a "cherry picker"; enroute or on-scene deaths are discarded.

EVERY human statistic needs to be "per capita" of a uniform population for comparison, and *in this case *the pt does not become a pt upon admission, they become one upon dispatch. 

The  pre-hospital EMS "profession" once again is trumped by the MD/hospital profession.


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## Veneficus (Jan 29, 2012)

mycrofft said:


> EVERY human statistic needs to be "per capita" of a uniform population for comparison, and *in this case *the pt does not become a pt upon admission, they become one upon dispatch.



Not going to happen.

Cost is prohibitive, systems are not compatible forcing this to be manually entered.

Various agencies would definately not want their stats analyzed.

Systems are too diverse for equal comparison anyway.



mycrofft said:


> The  pre-hospital EMS "profession" once again is trumped by the MD/hospital profession.



and will continue to be until EMS as a whole can demonstrate they bring knowledge and ability to the table and are not just "trained" to follow a cookbook that is either dictated to them or embraced by them.

Some places can do that, but they are the small minority so the data gained from them would at best be considered statistically insignificant at worst so diluted by the others that they would not even show up.

For example: little county EMS with a population of 250,000 has an extraordinary save rate of 50% of all cardiac arrest.

Now they are in a study with LA, Chicago, NYC, and Houston. 

Gaining good or even usable data on best practice in that scenario would be like pissing in the ocean and hoping it will turn yellow.

Not to mention the unreliability of dispatch information. (not always the fault of the dispatcher)

I have a great story where I saved the same person from "cardiac arrest" twice in the same shift simply by showing up. He refused transport both times.
(the takehome point is based on dispatch, that would skew the results as he was not really in cardiac arrest, or even unresponsive, for either call)


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## RocketMedic (Jan 29, 2012)

I wonder what would happen if we initiated a policy of one-month, six-month, and one-year follow-ups with all cardiac patients, with particular emphasis on cardiac arrest survivors?

Another huge part of the problem is that, within any one region, there's really not a lot of cardiac arrest survivors, and many of those who are arrested are not viable. Any research must involve a very large population to give us real results.


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## mycrofft (Jan 30, 2012)

Vene, I bet those two on the same person were counted as two discrete occasions too! Two saves in one night! Whatta MAN.


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## emtpche (Feb 1, 2012)

Just read the article detailing the study of ALPS and continuous vs. traditional CPR.  What I gather is that like many things I have witnessed in EMS and medicine is that it takes time to weed out the old guard(this is how I was trained).  I have taught ACLS and PALS for the last few years and I am amazed at the limited thinking that I come across when dealing with SCA.  We have proven to a great extent that CPR and defibrillation are the most effective treatment for patients.  Yet time and time again I have more folks wanting to push multiple doses of epi and intubate just for the simple fact that what they do where they work.

Current studies(don't have offhand) show that continuous compression's with no ventilation's(NRM) and limited interruptions has a better ROSC.  Not sure what the numbers are on the for discharge though.

And I agree with Veneficus until we change the education requirement and training EMS as a whole will not receive the respect or focus that can have a major change in the health and welfare of the community.  Even if we focused just 10% of EMS on public health it would have a major impact on ED's and hospitals as a whole


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