Recently, the Surviving Sepsis Campaign (SSC) launched their 2018 update. Although sepsis bundles have been brought up in the past, they are now pushing the limits by introducing a revised “hour-1 bundle” with the initiating time starting in triage. Initially, this may not seem like a big deal, but there are significant implications.
First, let us talk about recognizing sepsis. This is notoriously difficult since SIRS and qSOFA have problems with sensitivity and specificity. Those who are obviously sick are easiest to point out and this bundle will come naturally to those patients. But what about the elderly altered mental status that could just as likely be a stroke? What about the syncope patient where there are other factors that could delay the suspicion for sepsis? You can name any number of conditions that can lead to us easily going down the wrong pathway since it is not a classic patient. However, all of us will be penalized since the starting time for the clock is with the time to triage and not recognition of sepsis.
Let us talk about the triage time. How many hospitals have patients in their waiting room waiting to be seen who are complaining of some form of illness? Especially during flu season, we see this constantly. Does that mean that every patient who may possibly have sepsis needs to start this bundle? This is the problem with such broad statements for a patient population that is extremely diverse. The bundle implies that patients should be getting IVs, fluids, and IV antibiotics while still in the waiting room. This may be possible and even expected in some places, but there are significant risks. We have seen this in the past when such standards were in place for pneumonia treatment which led to less than optimal care.
Moving toward the bundle itself, this is intensive. Again, when these patients come in with a diagnosis of sepsis or where it is clearly present since they are critically ill, this is a no-brainer. However, as with many early sepsis patients, there is a high expectation of this to be done so quickly that even if they were in a room the labs may not yet be back to help recognize what is going on and to have the staff to perform everything needed. Patients need a lactate level and blood cultures performed. Because of the rules in place, this has to be done prior to broad-spectrum antibiotic administration (though it is also said that cultures should not delay antibiotics – pick one!). Empirically, all patients receive a 30mL/kg bolus of crystalloids for hypotension or a lactate of 4 mmol/L or more. After that fluid administration then vasopressors to maintain a MAP of 65mm/Hg or more. Again, in the critically ill patient, this is not as difficult, but this cannot be said for most of the patients in our EDs.
What about the level of evidence? There is some “moderate quality of evidence” but more are either “low quality” or a “best practice” statement. All said, to make strong recommendations without strong evidence is concerning. This is further exacerbated by a history of conflicts of interests (including 11 out of 24 of the guideline authors in 2008). Take for example how Eli Lilly sponsored SSC and was also the manufacturer of Activated Protein C. Despite controversy and neutral trials, it was recommended in guidelines until it was pulled from international markets in 2011.
Many have attempted to try and help correct the SSC and confront the issues. However, the guidelines are now changing with the SSC and a change needs to be made by allowing other groups, especially national organizations, to be allowed to opportunity to customize sepsis care for appropriate populations free of bias and by using appropriate recommendations based on the evidence. The fear is that if we do not act, and do so soon, we will continue to see implementation of the SSC guidelines by organizations such as the Centers for Medicare & Medicaid Services (CMS). The 2015 implementation of the SSC guidelines by CMS did not result in improved survival in adults with sepsis. EmCrit, PulmCrit, EMNerd, The SGEM, First10EM, and fellow supporters have been making their opinions known and there is currently an international petition to try and retract the 2018 guidelines. You can help make the difference. Sign the petition and make your voice heard.
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