Since its inception in 2002, the Surviving Sepsis Campaign (SCC) has sought to improve the quality of sepsis care, improve survival for patients with sepsis and increase awareness of sepsis to both those in healthcare and the public. In the medical community, the most recognized products of the SCC initiative are guidelines for the management of sepsis and septic shock, and the sepsis “bundles,” which are tools that healthcare organizations can use to guide implementation of evidence-based guidelines recognized to improve outcomes in the treatment of sepsis and septic shock. Directed by experts in critical care medicine from both the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine for the SCC, these guidelines are updated regularly and driven by updates to literature, research and knowledge surrounding sepsis.
Updates to clinical management guidelines typically precede the updates to the sepsis bundles. The first sepsis bundle was published in 2004 and included a “Sepsis Resuscitation Bundle” to be completed “as soon as possible” within the first 6 hours of presentation and a “Sepsis Management Bundle” to be completed “as soon as possible” within the first 24 hours. These initial bundles were revised in 2012 and changed to a “3-hour bundle” and “6-hour bundle,” with similar elements but an effort to perform the interventions within a shorter time period. These 3- and 6-hour bundles were further revised in 2015 with the elimination of central venous pressure (CVP) and SCV
O2 measurement. Driven by the release of the International Guidelines for Management of Sepsis and Septic Shock: 2016
) , a new bundle update was published in June 2018 titled “The Surviving Sepsis Campaign Bundle: 2018 Update.”
The new “Hour-One Bundle” includes 5 steps which are recommended to begin immediately upon presentation in all patients with clinical elements suspicious for sepsis or septic shock. “Time zero” is the time of presentation to triage in the emergency department OR if presentation occurs in a different setting (outpatient, nursing home, intensive care unit, hospital floor) “time zero” would be the first documentation in the chart with the elements of sepsis (Levy, Evans & Rhodes, 2018). It is understood that the interventions may not be completed within the hour.
The Hour-1 interventions are (Levy, Evans & Rhodes, 2018):
- Measure lactate level (repeat lactate if initial lactate elevated [>2mmol/L]).
- Obtain blood cultures before administering antibiotics.
- Administer broad-spectrum antibiotics.
- Begin rapid administration of 30mL/kg crystalloid for hypotension or lactate ³ 4mmol/L.
- Apply vasopressors if hypotensive during or after fluid resuscitation to maintain mean arterial pressure ≥ 65mm Hg.
While the central elements of the bundles remain consistent (lactate measurement, obtaining blood cultures, administration of IV antibiotics, IV fluid resuscitation and the application of vasopressors for those with refractory hypoperfusion), there have been significant changes over the years in the time frame during which these interventions should be initiated and completed.
The changes are based on the concept that sepsis is a medical emergency requiring immediate and timely intervention to improve survival not only at the time of presentation (“time zero”) but also during the subsequent hours of entry to the medical system (with ongoing evaluation and intervention). Furthermore, the measures provide points for data extraction to further improve the study of sepsis and sepsis outcomes. Since its inception in 2002, the implementation of the SCC bundles has led to more appropriate care in the treatment of sepsis and improved outcomes and survival (Prasad et al. 2017; Seymour et al. 2017). However, the guidelines and SCC bundles do not come without controversy. There are organizations that feel that the guidelines are too restrictive and due to their adaptation by the Centers for Medicare and Medicaid Services (CMS) with linkage to reimbursement, there is potential risk for conflict of interest between individual clinician clinical judgement and satisfying the core measures required for reimbursement.
Understanding the controversies
The general sentiment of those that are in disagreement with the SCC guidelines and bundles are largely that they favor a protocolized approach to care for those fitting the diagnosis of sepsis with less emphasis on clinical judgement and individualized care. Those with sepsis and septic shock may have significant variation in the acuity of their illness due to co-morbidities which could lead to variations in the delivery of care. Furthermore, the adaptation of sepsis core measure by CMS, linking the implementation of specific interventions to reimbursement leaves many healthcare providers conflicted. While it is understood that the intent of core measures is to ensure the provision of appropriate care across all those served by CMS thus preventing disparities in access to appropriate care, there is potential for exposure to inappropriate care, including inappropriate fluid administration and broad-spectrum antibiotics which could lead to more harm than good. With the regulatory guidelines, there is often no option to indicate to CMS as to why the interventions did not take place. An example would be the decision not to administer a 30mL/kg fluid bolus to a patient who flags for sepsis with no evidence of hypoperfusion and a co-morbidity of end-stage renal disease or congestive heart failure for fear of progression to acute respiratory failure due to volume overload. Lastly, an argument can be made that there is no perfect “sepsis screen” or single diagnostic tool, as opposed to some of the more urgent time-based clinical emergencies, such as STEMI where elevated cardiac enzymes and specific ECG changes allow for a diagnosis to be made with more certainty.
What should we do at the bedside?
It is important to remember that the guidelines are developed to guide and should be considered as they have proven to improve patient outcomes and survival (Seymour et al. 2017), but they cannot and should not be applied to every patient in the absence of sound clinical judgement. As nurses, it is imperative that we understand and know the most up-to-date recommendations and stay abreast of literature updates. We should ensure that care we provide is tailored to the individual patient. Those of us working in emergency rooms, intensive care units and on hospital floors spend more time on average at the bedside and play a key role in advocating for appropriate medical care.
As with the administration of any medication, it is essential to understand that there is potential for adverse outcomes from administration of IV fluids. It is important to remember that the goal of fluid resuscitation is to restore tissue hypoperfusion; if there is no response to fluids, there is no clear benefit for the continuation of fluids beyond the initial bolus and vasopressors need to be considered. There is no “one size fits all” for fluid resuscitation; treatment requires close and frequent hemodynamic monitoring and evaluation for response.
In a typical clinical situation, a call is placed to the medical provider when a patient develops a fever, hypotension, tachycardia, or if there is a “sepsis” alert via the medical record system. In these situations, we could expect an order for lactate measurement, blood cultures, broad spectrum antibiotics and possibly an order for 30mL/kg of crystalloids (either normal saline or lactated ringers). As the bedside nurse, we are responsible to know the clinical histories of our patients, the reason they were hospitalized as well as their clinical trends over the past 12 to 24 hours. If, as the bedside nurse, you were aware of a recent echocardiogram which revealed an LVEF of 10%, the delivery of a large volume fluid bolus should be questioned. While ultimately, the ordering provider is responsible for knowing the clinical history of the patient they are treating, there is an opportunity here to prevent a harmful medical intervention. In this specific clinical situation, you may postulate: Is there a degree of cardiogenic shock (lactate can be elevated in any type of hypoperfusion)? Was there a vegetation on the ECHO (is this patient at risk for endocarditis?). Given the poor cardiac function, and presence of unfavorable vital sign trends, this particular patient may require earlier transfer to an intensive care unit, central line placement and initiation of a vasoactive medication.
The goal of the SCC is to improve outcomes, survival and awareness of sepsis. Despite some controversies, the organization has been successful in accomplishing this which has been supported by several studies (Prasad et al. 2017; Seymour et al. 2017). Over the years, the bundles have evolved from 6-hour and 24-hours and 8 steps, to 3- and 6-hour with 6-7 steps and most recently, a 1-hour time frame and 5 steps stressing the importance of timely intervention in managing this medical emergency.
What has been your experience with sepsis? Does your hospital routinely utilize the sepsis bundles and has there been any recent discussions in your organization about the recent updates?
Levy, M.M., Evans, L.E., & Rhodes, A. (2018). The Surviving Sepsis Campaign Bundle: 2018 Update. Critical Care Medicine, 46(6), 997-1000. doi.org/10.1097/CCM.0000000000003119
Rhodes, A., Evans, L., Alhazzani, W., Levy, M., Antonelli, M., Ferrer, R., . . . Dellinger, R. (2017). Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2016. Critical Care Medicine, 486-452. doi:10.1097/CCM.0000000000002255
Seymour, C.W., Gesten, F., Prescott, H., Friedrich, M.E., Iwashyna, T.J., Philips, G.S., Lemeshow, S., Osborn, T., Terry, K.M., & Levy, M.M. (2017). Time to treatment and mortality during mandated emergency care for sepsis. The New England Journal of Medicine, 373(23), 2235-2244. doi: 10.1056/NEJMoa1703058
Prasad, P.A., Shea, E.R., Shiboski, S., Sullivan, M.C., Gonzales, R., & Shimabukuro, D. (2017). Relationship Between a Sepsis Intervention Bundle and In-Hospital Mortality Among Hospitalized Patients: A Retrospective Analysis of Real-World Data. Anesthesia & Analgesia, 125(2), 507-513. doi: 10.1213/ANE.0000000000002085