Immediate Myocardial Metabolic Enhancement During Initial Assessment

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This post was split off from another thread as I felt it needed its own.
 
GIK was researched back in the day. Evidence was sketchy then and its sketchy now. Pro's its a cheap and not very harmful therapy, but it does little for the 30 day survival rate. IMMEDIATE is powered to analzye 1-yr survival rates so it will be interesting to see what that data shows. There is a decrease in out of hospital/in hospital mortality but it's nothing to get excited about. Especially as you can read in the ACEP article it may be explained by infarct location or a host of other factors and proper subanalysis of the data has yet to be performed. As I said in the other GIK thread, the articles written about the IMMEDIATE trial are a whole lot more positive than the study itself, if you take the time to read it.


I don't think it's really a viable therapy and it will probably be discarded again like it was before, but applause to the researchers for investigating prehospital ways to improve MI pt. care.

I think focus should be spent on refining the basics, early recognition of STEMI, cath lab activation/transport to appropriate facility. I've worked places where this is done extremely well and places where it is done poorly. Across the board, there should be a stronger push for EMS to step up its game. STEMI is one of the few illnesses EMS can make a huge impact in. In the community setting I wish we saw more cardiologists get behind EMS. Interested to know, anyone work in a system where the cards guys are really pro-EMS?
 
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The whole study is free to download: Out-of-Hospital Administration of Intravenous Glucose-Insulin-Potassium in Patients With Suspected Acute Coronary Syndromes

It's kind of interesting - the original protocol was to look at 30-day and 1 year mortality, but in 2008 they changed it to "progression to MI."

The funny thing is, investigators sometimes switch the primary outcome during a trial so that they can (perhaps unfairly) produce a postive outcome. The study was still negative - there was no difference in progression to MI.

As for the mortality difference, the results are still quite possibly the result of chance. Even if they aren't, the 30-day mortality is still a bit more important than initial mortality - look at the controversy over the recent epinephrine study.

For a bit more explanation of the shortcomings in the GIK study, check out my longer analysis at The IMMEDIATE trial: Should EMS give Glucose-Insulin-Potassium? .
 
It's an interesting question of if it's okay to switch primary outcomes. I understand the impulse, especially when you are looking at something that turns out to be a rare event. So if you powered your study to detect a certain difference in mortality rate, assuming a baseline mortality rate of say 10%, and you start the study and find a mortality rate in the control group of 2%. What do you do? You are going to need a much bigger study to detect a difference made by the intervention, or you can examine another outcome rather than scrapping the study that has been done. Not sure if that's why the primary outcome was changed, but certainly always a red flag.
 
Yeah, there should be some leeway for adjusting things midstream, agreed. Transparency, as usual, probably should be the gold standard, rather than rigid adherence at all costs to the original protocol.
 
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