Many of you have undoubtedly seen or heard about the results of the proCESS trial published in today's NEJM.
The trial enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 445 to protocol based standard care, and 456 to usual care. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 8`1 in the protocol based standard-care group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care 1.04 (95% confidence interval [CI], 0.82 to 1.31; P=0,83; relative risk with protocol-based EGDT vs. protocol-based standard care, 1.15; 95% CI, 0.88 to 1.51; P=.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support. The authors conclude that in a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. While these results are important because the trial is multi-institutional and controlled, several issues need to be critically examined in the coming days. These results will be better examined by those less invested in the Campaign than myself and my colleagues. However, some issues to consider include: 1. There is a question of face validity for mortality rates such as reported here. Two accompanying papers in the same issue of the NEJM report severe sepsis mortality rates in the 30% range. 2. Each of these institutions were tertiary care institutions influence substantially over the last decade by the work of the Surviving Sepsis Campaign. Stated differently, 'usual care' has been systematically changed by the SSC over a decade already in terms of early resuscitation. 3. In all groups, the total % of enrolled patients that had central lines in 6 hours was approximately 60%. If most institutions on this listserv could have 60% central line placement, many of us would be very happy and likely have lower mortality rates. 4. There were 1300 patients excluded from this trial for logistical reasons. Thus, half the patients were excluded. This extraordinarily high rate requires further understanding. 5. 75% of enrolling sites had "sepsis protocols" and usual care occurred in same ED setting as the two protocol-directed arms. I think we have more to learn about protocolized resuscitation for sepsis. In many ways all 3 arms were quantitative resuscitation strategies. The results of ARISE and PROMIS should provide us with further understanding over time. Sean Sean R. Townsend, M.D. Vice President of Quality & Safety California Pacific Medical Center 2330 Clay Street, #301 San Francisco, CA 94115 email [email protected]<mailto:[email protected]> office (415) 600-5770 fax (415) 600-1541
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