alright boys.....Process study is out.....

[Hernandez]

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http://www.nejm.org/doi/full/10.1056/NEJMoa1401602?query=OF#t=comments

Discuss.....

 

[jdh71]

I think we all saw this coming. Lol

I have some thoughts but I'm not typing it out on my phone.

 

[ORL10]

I don't know how it will change my practice as an intensivist, or an ED doc. It is interesting to see that the mortality from sepsis is decreasing (see ausie study http://jama.jamanetwork.com/article.aspx?articleid=1850096 released same day and Derek angus editorial). I already don't: use CVP as a guide to fluid resuscitation, transfuse PRBC's to get to a crit of 30, or place an edwards catheter. i do use judicious fluids with frequent reassessment of volume status using PLR, US of IVC/echo with VTI and rarely PPV, trend lactates and or ScVO2 and like everyone else I use vasopressors/inotropes when I think they need it to keep maps somewhere reasonable (see http://www.nejm.org/doi/full/10.1056/NEJMoa1312173).

I know a lot of my colleagues in the ED were saying it gave them credence to avoid CVC which I think is fair to a point. I still think there is a role for CVC which I'm sure everyone on this forum has a good idea who those patients are.

What do others think?

 

[Bostonredsox]

It changes nothing for me. I am already gauging volume by bedside IVC US, I do not use scvo2 catheters, I hate them. I do check scvo2 in pts not meeting hemodynamic goals who I know have impaired LV function, but this is a case by case basis. We don't have a lactate clearing catheter, don't see the need, every pt on pressors I care for has an Aline and the rt can draw a poc lactate as often as I order it from the Aline. So I can do q1 or q2h lactates with a $4 arrow Aline catheter.

Essentially I will still be putting a line in these pts for multitude do reasons, though these reasons are more for MICU then the Ed so I get them not putting them in as often which is invariably what will happen, though at my shop they rarely put them in anyway.... I will still give 30ml/kg, then levophed, then vasopressin, then steroids. I will still add dobutamine if there uop sucks in the setting of poor LV function per my own echo assessment or known history of CM. They will still all have Aline's. They will still all be on low TV ventilation. I too like orl10 prefer fentanyl as my main sedative with as little pen benzo as I can give, most of these pts can't tolerate propofol.

Oh yeah, I will still give big mother****ing gun antibiotics until I have cultures.

So no, I don't see a whole changing on my/our end. EGDT is mainly an Ed therapy, though at my shop o get them 2 hours in with minimal volume resuscitation. This study affects what the Ed does in terms of there EGDT practice, it doesn't really affect us from hour 7 to day 10 that much.

 

[Hernandez]

[quote="Bostonredsox, post: 15040493, member: 384905This study affects what the Ed does in terms of there EGDT practice, it doesn't really affect us from hour 7 to day 10 that much.[/quote]

I find this ironic as almost every single one of the PROCESS pts ended up in the MICU prior to the protocol finishing and we had to finish it out, where I trained

 

[Bostonredsox]

I guess it depends on how quickly the pt gets to the MICU for a given hospital. And where I am it's the opposite, the protocol isn't started in the Ed. They usually get a liter, maybe two liters of saline, and some antibiotics. If the pressure is less than 90systolic they come up on levophed from a peripheral. Often times they have levophed because there pressure was 50 on arrival and the Ed nurse just titrated it up, never giving the ordered volume so it's like basically getting a fresh pt starting from time 0 minus the antibiotics. In this latter case we just employ EGDT from time 0, that being the pts arrival to MICU. And in that case, we put a CVC and art line in, give 30ml/kg, do a bedside echo, titrate the Levo as needed, add vaso as needed etc etc. I often check an scvo2 with my lactate on the first draw. If the pt has good LV function and the scvo2 is good, I don't check it again (with the subsequent lactate checks) unless there is a clinical deterioration I cannot explain.

So for the most part, not much of what I do with these pts changes with this study.

 

[jdh71]

I think we all saw this coming. Lol

I have some thoughts but I'm not typing it out on my phone.

I think most of us looking back on the Rivers' study recognized that EGDT was a concept desperately needed at the time, and got everyone thinking about being more vigilant about bird-dogging sepsis and also much more aggressive in resuscitation. Those were the real "take-away" messages when the dust all settled following the study IMHO - the "big change" that occurred in the collective consciousness of people treating sepsis. And this is the biggest reason why I think Rivers got significant differences THEN and you simply won't see significant difference between EGDT and "usual care" now. Everyone "gets it" - the idea, the concept - so it doesn't surprise me at all.

Will it change what I'm doing? No. I've never had the luxury of using fancy catheters anyway in my training. I do like the additional ammunition to kill the CVP monitoring. I will still put in central lines and disagree with a lot of the noise over in the EM forum about the CVC being "dead" after this. Maybe they are comfortable with vasopressors through big enough peripheral veins during the time the patient spends in the ED, but I'm not comfortable with the DAYS and levels of pressors these patients often end up needing ever putting any of that through a peripheral line.

I also wonder what kind of bias my be inflicted by knowing you are part of a study that is observing prospectively how well you are doing keeping patients alive, comparing your skills to an algorithm, especially if you think the algorithm is a little to a lot of garbage?? I kind of wonder just how "usual" of care ANY patient gets in this kind of setting. Though . . . it's probably NOT the experienced hands at tertiary critical care centers who are or ever really were the target audience for a protocolized sepsis treatment algorithm, no?

Why is it that coming out of an academic fellowship I just cannot help but think everything published is garbage?? Lol (some more, some less)

 

[Hernandez]

They collected enough data that they should be able to ge a feel for what usual care entailed, I'm pretty sure all the protocalized arms PTs got CVCs early at my shop, granted we weren't a huge number enrolling center. The CVC isn't dead, despite the ERs joy.


Sent from my iPhone using Tapatalk

 

[jdh71]

They collected enough data that they should be able to ge a feel for what usual care entailed, I'm pretty sure all the protocalized arms PTs got CVCs early at my shop, granted we weren't a huge number enrolling center. The CVC isn't dead, despite the ERs joy.


Sent from my iPhone using Tapatalk

My point was "usual care" at a tertiary care shop is going to be good care and I would t expect it to be any different especially on light of the "big picture" that the Rivers study originally brought to the collective consciousness of the field.

If you were *actually* and seriously trying to show a difference I think they picked the wrong groups to compare at the wrong locations.

Yay for the NEJM publication. But like much of what they publish I'm very underwhelmed.

 

[Bostonredsox]

I think it's sort of like oscillate and oscar. HFOV compared to current standard of care (low tv low plateau) didn't show significant benefit over the trials 15 years ago when HFOV was compared to current standard of care then, which wasn't low tv , low plateau. The current standards for EGDT even if not protocol driven are going to be similar to rivers 2000 study. Everyone is gonna get an early 30ml/kg, then levophed, early antibiotics, and recurrent volume status reassessments with titration of pressors + additional fluid.

The only thing I really take from it is the scvo2 target itself isn't overly critical, but we knew that right? In the setting of good LV function, patients rarely have low scvo2s and rarely require an ionotrope. And as for the CVC, here is a multitude of reasons see pts need a CVC during there ICU stay NOT including CVP monitoring. I totally agree with JDH, I do not give pressors through peripherals. 30 min of Levo through an 18 in the Ed until they get to us? Ok. But they're getting one upstairs.

For me it boils down to large fluids up front, broad spectrum antibiotics given in the Ed, lines ( I put Aline's in anyone on a pressor or in afib, you can argue the data isn't there but there cheap, minimally invasive, and I prefer them), Serial lactates which is probably the most important of all data points, and recurrent measurements of IVC size to guide volume status. If the pts are in the Ed for an hour to 90 minutes before getting to us, all that matters to me is they've given the initial antibiotics, got cultures and given the initial volume challenge. The rest I will deal with. This study did nothing to change that.

 

[Doctor Bob]

The CVC isn't dead, despite the ERs joy.

I admit, I'm not sure why my colleages are so excited about not having to do CVCs anymore. Sure, when you're trying to wade through a packed waiting room, stopping to do a CVC drops your productivity. But it doesn't take me any more time to place a CVC than it does to figure out the story of the stage 4 metastatic fibromyalgia patient with back pain and hypovicodinemia.

I'm happy that I have some ammunition to stop protocolizing CVC placement in every "septic" patient, but it won't stop me from putting them in when the clinical situation is appropriate.

 

[mrpankration]

I think another interesting aspect of this article is the way that it is already impacting systems-based practice in large healthcare systems. As an example, I practice in Kaiser NorCal where EGDT was practiced like it was gospel, and if you deviated away from any aspect of it, no matter how minute, you would get feedback letters and everything. Within 2 days of this studies publication, things are already changing and we are now being told to eliminate CVC placement strictly for the purpose of catheter-based hemodynamic and physiologic measurements. I think it's funny how practice paradigms can change so quickly and wonder whether other large healthcare systems or academic centers are also following suit.

 

[europeman]

I think I would kill myself if I had to work at an institution like you are describing where you are so forced to work within their "box" of a paradigm. That's absurd. I didn't realize there were places like that which existed!

Were you transfusing to hct 30 on all severe sepsis too?!?! That's nuts

 

[mrpankration]

It was all protocol driven, so if a patient with severe sepsis/septic shock came to the unit, there was an EGDT order set and once patients were on the EGDT protocol, the RNs just followed down the pathway. So if a patient had a Scv02 < 70 and they were already maxed on Dobutamine with their other goals met, then yes, they would get transfused PRBCs if their Hct was < 30. That was the whole point of the protocol, to decrease inter-physician variability in sepsis management. It's not a practice model that I'm necessarily thrilled about but I am in agreement that protocols or clinical-decision tools are helpful at least as starting points to standardize practice, especially if significant practice variations exist but there is supporting data for a particular treatment pathway. Kaiser does take it a bit far at times though, I once had to justify why I did not place an an IJ CVC in a patient coming in with septic shock who had a PICC but the PICC was not the source. My rationale for not placing an IJ was that we had a PICC which could do everything the IJ could do except measure CVP, which in my mind, was not sufficient justification for placing an IJ given it's poor predictor of volume responsiveness/volume status. It ended up being ok but it just goes to show that some people/institutions take protocols a little too far and lose sight of common sense.

 

[redy]

It was all protocol driven, so if a patient with severe sepsis/septic shock came to the unit, there was an EGDT order set and once patients were on the EGDT protocol, the RNs just followed down the pathway. So if a patient had a Scv02 < 70 and they were already maxed on Dobutamine with their other goals met, then yes, they would get transfused PRBCs if their Hct was < 30. That was the whole point of the protocol, to decrease inter-physician variability in sepsis management. It's not a practice model that I'm necessarily thrilled about but I am in agreement that protocols or clinical-decision tools are helpful at least as starting points to standardize practice, especially if significant practice variations exist but there is supporting data for a particular treatment pathway. Kaiser does take it a bit far at times though, I once had to justify why I did not place an an IJ CVC in a patient coming in with septic shock who had a PICC but the PICC was not the source. My rationale for not placing an IJ was that we had a PICC which could do everything the IJ could do except measure CVP, which in my mind, was not sufficient justification for placing an IJ given it's poor predictor of volume responsiveness/volume status. It ended up being ok but it just goes to show that some people/institutions take protocols a little too far and lose sight of common sense.

Wow. That's scary.

 

[europeman]

Wow that's amazing. I mean we see on different coasts at differ t institutions so for me your story is just fascinating. I just didn't realize protocols have gotten to such an extreme at other places for docs. I just never knew

 

[sluggs]

Why can't I find the Process Trial in a "regular issue" of NEJM??

 

[jdh71]

Why can't I find the Process Trial in a "regular issue" of NEJM??

You mean in print?

I put "process trial NEJM" into google.

The first link is the paper: A Randomized Trial of Protocol-Based Care for Early Septic Shock

I can easily download a PDF and send it to any email you want to PM (though, you should have access to the NEJM anywhere you're working?)

 

[sluggs]

I have the article, thanks. I was just trying to find the issue, but it was not in a particular issue. It was a"special print" or something to that effect!

 

[K31]

I have the article, thanks. I was just trying to find the issue, but it was not in a particular issue. It was a"special print" or something to that effect!

It's just out as an e-publication at this point. It is not unusual for there to be a several month lag between electronic publication and the article actually being in an issue of a journal.

 

[QofQuimica]

I think most of us looking back on the Rivers' study recognized that EGDT was a concept desperately needed at the time, and got everyone thinking about being more vigilant about bird-dogging sepsis and also much more aggressive in resuscitation. Those were the real "take-away" messages when the dust all settled following the study IMHO - the "big change" that occurred in the collective consciousness of people treating sepsis. And this is the biggest reason why I think Rivers got significant differences THEN and you simply won't see significant difference between EGDT and "usual care" now. Everyone "gets it" - the idea, the concept - so it doesn't surprise me at all.

Agree completely with this. It's less the specifics of what Rivers did that mattered, and more the increased awareness of the importance of recognizing and treating sepsis early that we now all have.

 

[Hernandez]

http://www.nejm.org/doi/full/10.1056/NEJMoa1404380#t=article

I like Pulmcc's commentary.....replace all sepsis protocol sets with copies of these studies at the nurses station.

 

[souljah1]

ProCESS and ARISE randomized after a solid fluid bolus and early/appropriate antibiotics, which means that most of what drives a patient's outcome was done prior to randomization. This is in stark contrast to the Rivers study where fluids and antibiotics occurred after randomization. Given that the intervention arm more often had Rivers in it - you have to wonder about biases away from null. Also, Rivers study was in era of large tidal volumes - which may have drived the higher mortality rates.

My take away is that if you give early fluids and broad spectrum antibiotics then whether you check ScvO2 and/or lactate serially matters less in the early hours of septic shock. Same goes for liberal transfusions - and if you look at TRISS as well as prior observatoinal work - a restrictive strategy should be encouraged.

Cheers.

 

[jdh71]

I'm just gunna do what I want!!!

Idgaf

I'm out of control.

 

[Doctor Bob]

Hetastarch, oscillators, and xigris for everyone

 

[Hernandez]

Hetastarch, oscillators, and xigris for everyone

And pass the renal dose dopamine.....