The ProCESS of Dismantling Early Goal-Directed Therapy

On the Shoulders of Giants

Spoon Feed
There was no mortality advantage to early goal-directed therapy (EGDT) over protocol-based care (using lactate clearance), or usual sepsis care.

Why does this matter?
EGDT changed the way we thought about sepsis care. But many were concerned that invasive ScvO2 monitoring and protocol-based inotropes and transfusions were unhelpful.  Subsequently, it was shown that lactate clearance worked as well as ScvO2 monitoring.  The only way to prove that not all aspects of the EGDT protocol were necessary was to do a RCT, and that is exactly what they did with ProCESS.

The ProCESS of rethinking EGDT
This was a large, multifactorial, multi-center study of protocol-based EGDT vs. protocol-based care (no central venous monitoring of ScvO2, no required inotropes, or required blood transfusions) vs. usual care, with 150 patients in each group.  Non-EGDT protocol-based care was essentially lactate clearance (see last week's landmark article).  There was no difference at 60 days, 90 days, or 1-year follow up between protocol-based care (either EGDT or non-EGDT) and usual care.  There was also no difference between EGDT and protocol-based standard care.  Overall mortality rates were all lower than the original EGDT study: 21% EGDT, 18.2% protocol-based standard therapy, and 18.9% usual care.  Recall, EGDT had 30.5% mortality compared with 46.5% for usual care.  The quality of sepsis care in general had markedly improved over the 13 years from EGDT to this study.  Thing is, we probably wouldn't have the quality of "usual care" for sepsis we currently enjoy had it not been for EGDT forcing us to pay more attention and focus on early identification, source control, IV fluid, and early antibiotics for sepsis.

A randomized trial of protocol-based care for early septic shock. N Engl J Med. 2014 May 1;370(18):1683-93. doi: 10.1056/NEJMoa1401602. Epub 2014 Mar 18.

Another Spoonful
WikEM has an outstanding review of this study, worth a read.

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