Not quite ten years ago I conducted a multidisciplinary journal
club looking at the original Rivers study on Early Goal Directed Therapy for
sepsis. Despite the EM community embracing this new concept, my critical care
colleagues were certainly less impressed. Well to be fair, they absolutely
lambasted the study and could not believe that any reasonable person would
change their practice based on one small study conducted in a single
institution showing an unbelievably large treatment effect. After all, they had
been conducting their own studies of ICU goal directed therapy for years to no
avail.
It has taken over a decade for another more definitive RCT looking at EGDT in the form of the much
publicised ProCESS trial. The authors
are to be congratulated for their efforts. In a nutshell, they conducted a large
multicenter RCT at 31 emergency departments in the USA. Patients with septic
shock were randomly assigned to one of three treatment arms; the Rivers EGDT,
protocol based standard care (without mandates for central lines,
pressors or blood transfusions), or usual care (whatever the doctor
wanted to do). The primary outcome was in-hospital mortality at 60 days. I
think we all know the results showed no
difference with mortality around 20% in all three groups. More patients in
the EGDT went to the ICU, got transfusions and dobutamine. EGDT is officially dead.
To be fair, EGDT has been dying a death of a thousand cuts
since it was originally published in 2001. There has been a mammoth amount of
research and emphasis on sepsis care since its release and modifications of the
original protocol have been ongoing. There still are two more large RCT’s yet
to come from the UK and Australia so perhaps we still have more to learn.
I have always concerned about the resource implications of EGDT. In particular the harms it might
create especially in smaller ED’s by diverting attention away to perform far
from proven tasks. In the end it looks like early recognition, aggressive fluids
and early antibiotics are still the mainstay of care- surprise, surprise.
There is no doubt this study will change the guidelines as put
out by the Surviving Sepsis Campaign. But I don’t think there is any reason to
wait for their formal recommendations. After all this “campaign” was originally
created and funded by a public relations firm hired by Eli Lily in order to
promote their now defunct drug Xigris. Shame on us...
What is the take home message? Please, please, please be
sceptical of small studies showing large treatment effects especially when they
show the unbelievable. Now scoop some dirt on the coffin of EGDT... too good to
be true.
Covering:
Yealy, DM, Kellum JA,
Huang DT, et al. A Randomized Trial of Protocol-Based Care for Early Septic
Shock. N Engl J Med 2014;370(18):1683-1693.
http://www.ncbi.nlm.nih.gov/pubmed/24635773
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