“ProCESS” for Improvement or Reason for Caution

“There is no such thing as the world of letters apart from the world of men…The scholar without this vision is a pedant.  He mistakes learning for an end in itself, instead of seeing that it is only a weapon in a wise man’s hands.” (Seth Low, 1890 -quoted in NEJM 2014; 370: 1679).

While sepsis, “the syndrome of dysregulated inflammation that occurs with severe infection,” is not frequent among pediatric gastroenterology patients, it does occur. Pediatric GI patients at risk include patients receiving immunosuppression medications, patients with inflammatory bowel disease, and patients with central lines.  So, it is not simply an academic exercise to understand the efforts to improve sepsis treatment. A recent study and related editorials discuss the role for protocols in treating sepsis, and likely have broader implications [NEJM 2014; 370: 173-76 (editorial-http://nej.md/1hYoAXc ), 1683-93 (article-http://nej.md/1qvKwBc ), 1750-51 (editorial-http://nej.md/1gkt6D2 )].

Overall, sepsis was reported as the 11th leading cause of death in the U.S. in 2010 and was the single most expensive condition treated in hospitals.  Nevertheless, the diagnosis is in part subjective and these statistics rely on insurance claims.

Key points:

  • Policymakers in New York require hospitals to adopt sepsis protocols (“Rory’s regulations”) following the death of a 12 year-old boy who died from unrecognized sepsis.  Other agencies, like the National Quality Forum (NQF), have recommended this as well. The Centers for Medicare and Medicaid is considering whether to adopt the NQF metric.
  • The ProCESS (Protocolized Care for Early Septic Shock) study (31 centers) enrolled 1341 patients (average age 61 years) into 3 randomized separate arms: protocol-based goal-directed therapy bundle, protocol-based standard therapy, and usual care. Conclusion: protocol-based resuscitation did not improve outcomes.
  • Sepsis mandates are not without risks.  Overdiagnosis can lead to unwarranted antibiotics, excessive testing, excessive blood transfusions, diversion of scarce ICU resources, and complications from central line placement.
  • Two more multicenter studies are underway (ARISE and ProMISE) which will further determine the utility of protocoled sepsis care

While the ProCESS trial did not identify improvements in protocol-driven care, most patients (76%) in all three groups received antimicrobials by the time of randomization (mean of ~3 hours).  Thus, early recognition of sepsis with treatment, particularly antibiotics and volume resuscitation, remain critical.  The editorial (pg 1750) imparts some useful advice from Machiavelli: “the physicians say it happens in hectic fever, that in the beginning of the malady it is easy to cure but difficult to detect, but in the course of time, not having been either detected or treated in the beginning, it becomes easy to detect but difficult to cure.”