Today, the New England Journal of Medicine just released a landmark paper by the ProCESS (Protocolized Care for Early Septic Shock) trial investigators. There has already been much buzz about this on various blogs and websites, including St. Emlyn’s, MedPageToday, and MDAware. I received an email from my colleague Dr. Michael Callaham, who shared some direct comments and pearls from Dr. Donald Yealy, (professor and chair of emergency medicine from the University of Pittsburgh Medical Center) who was the first author of this writing team. Thank you to Dr. Yealy for allowing me to share your team’s comments with the ALiEM readership.
ProCESS Investigators. A Randomized Trial of Protocol-Based Care for Early Septic Shock. New Engl J Med. 2014 (early online release – free PDF download)
Google Hangout on April 1, 2014 with Dr. Yealy
Here is the Surviving Sepsis Campaign response to the ProCESS Trial mentioned, which advocates for still the full sepsis bundle despite the ProCESS Trial findings.
A few key points we see (though not exhaustive):
- The different resuscitative approaches did not create one clear superior method, and while some resource use varied, the primary and secondary analyses largely agreed on this observation. Of our three, no one resuscitative path is bad or better; this allows sites the flexibility of crafting best local approach to care within these constructs.
- The study groups were treated differently – in other words, we did an experiment. There is no evidence of contamination.
- Overall, adherence to protocols was very good, and ancillary care – esp. antibiotic delivery – was also very good. These are key features.
- While our cohort differs in some ways from the 2001 Rivers cohort – not a surprise –both trials included very sick patients with similar vital signs and APACHE on presentation.
- Overall, mortality is much lower than reported in 2001 – a very good thing and reason why this isn’t a ”negative trial”, but a refining trial showing early recognition and resuscitation are key – there is more than one way to do the latter. However, sepsis remains a killer, more than many other ED/ICU illnesses like acute MI/CVA.
- We did not study delayed recognition or care – these results validate the Rivers dictum that seeking sepsis in all forms early and treating to deter the cycle of propagation is key.Our observations apply to settings where sepsis is aggressively sought and treated early.
JAMA also published a paper today, supporting the ProCESS study view that shifting definitions alone do not explain the improved mortality.
Kaukonen KM, Bailey M, Suzuki S et al. Mortality Related to Severe Sepsis and Septic Shock Among Critically Ill Patients in Australia and New Zealand, 2000-2012. JAMA. (Published online March 18, 2014 – free PDF download).
Iwashyna TJ, Angus DC. Declining Case Fatality Rates for Severe Sepsis: Good Data Bring Good News With Ambiguous Implications. JAMA. 2014. (editorial - free PDF download)