process study-sepsis treatment protocol

ProCESS Study: Identify sepsis early and treat aggressively aliem.com /process-study-identify-sepsis-early-treat-aggressively/ Michelle Lin, MD 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. Citation 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. Donald Yealy, MD 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

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summary of ProCESS study on treatment of sepsis

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ProCESS Study: Identify sepsis early and treataggressively

aliem.com /process-study-identify-sepsis-early-treat-aggressively/

Michelle Lin, MD

Today, the New England Journal of Medicine just released a landmarkpaper by the ProCESS (Protocolized Care for Early Septic Shock) trialinvestigators. There has already been much buzz about this on variousblogs and websites, including St. Emlyns, MedPageToday, andMDAware. 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 ofPittsburgh Medical Center) who was the first author of this writing team.Thank you to Dr. Yealy for allowing me to share your teams commentswith the ALiEM readership.

Citation

ProCESS Investigators. A Randomized Trial of Protocol-Based Care for Early Septic Shock. New Engl JMed. 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 forstill the full sepsis bundle despite the ProCESS Trial findings.

Donald Yealy, MD

A few key points we see (though not exhaustive):

The different resuscitative approaches did not create one clearsuperior method, and while some resource use varied, the primaryand secondary analyses largely agreed on this observation. Of ourthree, no one resuscitative path is bad or better ; this allows sitesthe flexibility of crafting best local approach to care within theseconstructs.

The study groups were treated differently in other words, we did anexperiment. 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 bothtrials 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 thisisnt a negative trial, but a refining trial showing early recognition and resuscitation are key thereis 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 thatseeking sepsis in all forms early and treating to deter the cycle of propagation is key.Ourobservations apply to settings where sepsis is aggressively sought and treated early.

Bottom line

We relearn that more care is not always better care. Derek, Don, John, David, Amber, and the ProCESS Team

Addendum

JAMA also published a paper today, supporting the ProCESS study view that shifting definitions alone donot explain the improved mortality.

References:

Kaukonen KM, Bailey M, Suzuki S et al. Mortality Related to Severe Sepsis and Septic Shock AmongCritically 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 NewsWith Ambiguous Implications. JAMA. 2014. (editorial free PDF download)

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