Gosh, hardly a day goes by in the world of FOAMed without another tweet alerting me to the wonders of research. Today is no exception and despite being here at SMACCGold, needing to go for a run, finish my talks for tomorrow, get to the bar and see friends this cannot be missed.
Now I am sure that you have invested in early goal directed therapy for sepsis. In systems, education, equipment, protocols and most importantly intellectually you have invested heavily in the requirements of EGDT following the River’s study in 2001. You should read it again now on this link EGDT.
There have been criticisms of this formulaic approach that requires central access and not all clinicians have adopted the protocol, though in the UK there has been widespread adoption and further trials with modifications to the process (but with the same principles of protocol based care). PROMISE is one such trial nearing completion in the UK looking at protocolised sepsis care.
So, today we finally have the publication of the ProCESS trial in the NEJM. Abstract link below. This has to brief as I have so much to do tonight and we will have more to follow, but a quick read through suggests that EGDT does perhaps unexpected finding. The question we need to ask over the next few days is why?
There are some obvious similarities with the recent findings about targeted temperature management.
Firstly, this is still a small trial to identify differences and we can see that in the confidence intervals. Is it looking for differences, non inferiority or equivalence?
Secondly, look at the improvement in mortality from the original Rivers trials (30-40%) to this trial (18%). Either this is a different group of patients or much much more has changed than simply the introduction of protocols since 2001.
Lastly, we need to be cautious about contamination here. The principles of EGDT are well known and widely applied even if they are not part of a strict protocol. The differences between a strict regime and what has now become common knowledge and practice since 2001 are unlikely to be as dramatic as they were back in 2001. We must ask ourselves whether this is a failure of a protocol to be different or rather the success of it’s dissemination to a wider clinical practice.
I need to read it in more detail, but for now the run and SMACCGold celebrations beckon.
Oh, and does anyone else think that NEJM timed the release of this paper to coincide with the greatest resuscitation conference in the universe? You know I think they might……
vb
S
I would be happy to see sepsis management simplified but the EGDT group in this study appears to be more unwell..
The EGDT grp had Higher percentage in high lactate group. (p 0.05)
EGDT group also trends to higher APACHE2, higher percentage with high lactate (>5.3), longer time to randomization, more with refractory low BP as reason for enrolment, higher rate of intraabdominal sepsis (v pneumonia/ UTI) and higher pos culture rate. Whilst p values for these are either non significant or not reported the combination of this and the expected Hawthorne effect means I will not be condemning protocolised care until more infomation is revealed..
Not sure why they didn’t acknowledge this..
By the way…enjoyed/ learnt from all your talks at SMACCGold and Incisive SIMWars mentoring..Brilliant stuff..thanks
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