In 2001 a sepsis definitions conference was held to determine whether new data existed to inform updates to the sepsis criteria established in 1991. Afterward, the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM) announced plans to launch the Surviving Sepsis Campaign (SSC) with the goal of reducing mortality from sepsis by 25%. Given the prominence of sepsis and septic shock as emergency conditions, it is worthwhile to review how care has evolved to its current format and the future directions it may take.
At its inception, the SSC strove to achieve an increase in sepsis awareness and the initial articulation of questions and answers regarding sepsis diagnosis and care (www.survivingsepsis.org). That structured process generated the initial guideline, and its translation to the bedside—a bundled approach to care. This same coupled structure—guidelines that explore current evidence—and bundles that translate that evidence to an increasingly refined group of care elements—continues to drive the work of the SSC and all other SCCM quality improvement programs today. Each evolution of guideline and bundle reflects newly acquired evidence that informs improvements in care including initial assessments, rescue therapies, reassessments, and of course, antimicrobial treatments. Perhaps most prominently, the bundles also embrace sepsis and septic shock as medical emergencies that require rapid recognition and treatment. (Dellinger RP, et al. Crit Care Med. 2004;32:858-873).
Along the way, each new guideline and bundle iteration incorporated newly published data on how each guideline and bundle performed. (Levy MM, et al. Crit Care Med. 2010;38:367-374; Dellinger RP, et al. Crit Care Med. 2013;41:580-637; Rhodes A, et al. Crit Care Med. 2017;45:486-552). The same is true today. In the wake of mandated protocolized sepsis care in New York State, we now have multiple lines of evidence that protocolized sepsis care works—and more are on the way (Seymour CW, et al. N Engl J Med. 2017;376:2235-2244; Kahn JM, et al. JAMA. 2019;322:240-250). Decreased mortality appears tied to increased adherence to bundle elements that were articulated in the original 6-hour bundle, then the 3-hour bundles. Importantly, those bundles identified care elements that were to be completed in those time frames. Changing behavior often engenders conflict, and changing terminology often functions in the same way. The most recent bundle shifted both focus and language, moving from completion to initiation, and 3-hour to hour-1 (Levy M, et al. Crit Care Med. 2018;46:997-1000).
Confusion and a torrent of concerns followed quite rapidly from a variety of sources. The SSC responded to valid concerns about timing, recognizing the challenges encountered in emergency departments (EDs). Those concerns reflected the major challenge in identifying the patient with sepsis (as opposed to similarly presenting conditions) as well as ongoing issues with ED overcrowding and boarding. An equally important problem was the initial time frame from which the counter for the initiation of care was triggered. The initial trigger of the hour-1 bundle was time of triage—a readily identifiable marker from the electronic health record. While ideal for benchmarking, it proved nearly impossible to embrace in an oversubscribed ED with a host of patients waiting to be evaluated. Such is the reality in many EDs, and nearly all of them during a challenging flu season. The SSC responded to emergency medicine’s concerns by changing the trigger to the time of recognition of sepsis—a change that recognized the difficulties in identifying the patient with sepsis, as opposed to those with more readily recognizable septic shock (www.survivingsepsis.org).
Nonetheless, the nomenclature change that sparked the rest of the controversy remains. Hour-1 is meant to reinforce the emergency nature of sepsis and septic shock care. Once sepsis or septic shock is recognized, clinicians are encouraged to take each of the following steps within the first hour of that recognition: starting fluid resuscitation, obtaining cultures, delivering empiric antibiotics, assessing markers of perfusion such as lactate, and initiating vasopressors as needed to support the patient’s mean arterial pressure.
It is essential to realize that the intent of the hour-1 bundle is to start therapy in a rapid fashion, but not to mandate completion within that single-hour timeframe. If you could do so—well done! Difficulties in rapid fluid administration for those with heart failure, the timeliness of receiving vasopressor infusions as well as antibiotics from pharmacy, and other structural issues across different institutions and systems render bundle completion within one hour unrealistic for many.
The SSC has recently embarked on a revision of the 2016 guideline and bundle. Emerging data as well as missing elements such as source control may inform the next iteration of care improvements. Data science and large database analysis—such as that of the New York State Department of Health—will prove pivotal in generating both questions to answer and therapies to deliver. Perhaps they will even spur a change in nomenclature that will not be controversial but will instead garner enthusiasm for pursuing evidence-driven changes in care. The goal of SCCM and ESICM is improving care quality in support of excellent patient outcomes. To that end, the SSC has been highly successful. Whereas sepsis was barely known even within our profession when the campaign was launched, today sepsis is recognized and treated much more rapidly than ever before; as a result, mortality from sepsis has significantly decreased. We remain committed to supporting the SSC and other quality initiatives, which over time means that care recommendations will change as knowledge evolves. This is the nature of medicine and how improved patient outcomes are achieved.