I will suggest a counter to the observation that the PROCESS trial does not
represent most US hospitals.
We have 2 US-based studies now with ED-centered randomization and similar
mortality rates. The smaller scale multi-centered RCT (Jones) and the larger
scale multi-centered RCT (PROCESS) have near identical overall mortality rates
to each other (Jones: overall mortality 59/300 = 19.7%; PROCESS: overall
mortality 259/1341 = 19.3%). Each of these used identical inclusion criteria to
the original EGDT study and identical inclusion criteria to current SSC
guidelines.
The other 2 studies mentioned in the same NEJM release did have higher
mortality rates. However, they do not represent the same population as
addressed in the Emergency Department-centered PROCESS study. The albumin in
sepsis study (Caironi et al) is an Italian ICU based patient population with
“severe sepsis or septic shock”, very different population than PROCESS or
Rivers. The high vs low MAP target study (Asfar et al) is a French ICU-based
patient population with vasopressor dependent septic shock, again, not the same
population as the PROCESS or Rivers study.
Even if ARISE and PROMISE reflect a different trend or outcome, from a US
hospital perspective, PROCESS is as applicable if not more so for a US-based
hospital system.
From PROCESS, it would seem that there is change supported in current care:
Mandated central line placement for all patients is unsupported (i.e.
does not improve mortality).
Mandated CVP assessment and ScvO2 assessment for all patients is
unsupported (i.e. does not improve mortality).
There is a high likelihood of a Hawthorne effect in the usual care arm, where
the treatment team may have been more attentive and aggressive in resuscitation
and monitoring knowing they were being “watched", which is the bottom-line
message we all advocate for and seems to be important across the board: be
attentive / be aggressive. The usual care care in Process was great care as
was pointed out, timely fluids and antibiotics, central lines when indicated,
and all this continues to support early recognition, aggressive up-front
fluids, and early antibiotics. If central access is necessary to treat fluid
refractory hypotension with vasopressors, I think a case can be made for
assessment of both CVP and ScvO2 as they are valuable measures if low, but much
less helpful, if at all, when normal.
I think PROCESS will translate to an overall improvement in sepsis recognition
and care, where clinicians are more likely to participate in sepsis
resuscitation now that they are supported with a less-invasive alternative than
is currently suggested.
Ryan
Ryan Arnold, MD
Department of Emergency Medicine
Christiana Care Health System
Newark, DE
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