In their piece suggesting the Surviving Sepsis Campaign (SSC) guidelines be retired, Marik et al make several misleading statements. First, it is important to understand the differences between guidelines, bundles, clinical protocols, and performance measures, which are conflated as equivalent. Clinical practice guidelines follow a clearly defined methodology to make evidence-based recommendations. Bundles, which are derived from guidelines, are tools to facilitate implementation at the bedside with defined targets. Protocols are tools for putting guidelines or bundles into operation. Measures are ways to track and report performance. All are important quality improvement tools.
Second, it was stated that SSC has not been responsive to new evidence. SSC has responded to new, published evidence with each iteration of the guidelines: tight glucose control, drotrecogin alfa, and the recommendation for central lines for protocol-based resuscitation were all removed in response to strong published evidence that failed to confirm earlier trials. The cornerstone of the SSC guidelines has always been the evidence-based review of the literature that supports guideline development. Because the bundles are derived from the guideline recommendations, they are also evidence-based.
There are robust and consistent published studies and meta-analyses supporting the association between implementation of sepsis bundles and improved survival. Furthermore, there has never been harm demonstrated with bundle implementation.
Nothing in the SSC bundles “pressures physicians to administer treatments despite their best medical judgment.” If a physician, based on his or her bedside assessment, feels an element of the bundle is inappropriate, that physician should document that assessment and decision and act accordingly.
Regarding specific elements of the SSC bundle, additional statements require rebuttal. The claim that the administration of 30 mL/kg of crystalloid fluid for patients with hypotension and/or an elevated lactate is likely harmful is not founded in evidence and fails to consider data from published trials using the bundles and the use of 30 mL/kg as the median amount of fluid administered before randomization in the three large international randomized clinical trials that evaluated Early Goal Directed Therapy. SSC bundles do not recommend 30 mL/kg for any ill patient with suspected infection, but for hypotension and/or an elevated lactate. As for antibiotics, multiple studies have consistently demonstrated increased mortality associated with every hour an institution delays antibiotic therapy in sepsis and septic shock.There is also evidence linking lactate to improved outcomes.8
The Hour-1 bundle was introduced based on two concepts: First, time to initiation of therapy is a critical determinant of outcome; and, second, a recognition that most clinicians faced with a critically ill patient with sepsis-induced hypotension will choose to commence (not necessarily complete) implementation of all aspects of the 3- and 6-h bundle immediately, rather than delay treatment.
In conclusion, we end our rebuttal with the same statement with which we ended our first statement: It seems that we would all want our loved ones to be cared for in institutions that can consistently and reliably meet these continuously evolving performance metrics. Our families and our patients deserve nothing less.
- antibiotic therapyEditorialevidence based practicehumanpractice guidelinepriority journalsepsisseptic shocktreatment outcomesepsis Humans Sepsis