The Surviving Sepsis Campaign (SSC) care bundle is designed to quickly identify and treat cases of sepsis in hospital emergency departments (ED). The updated care bundle is based on 2016 guidelines and recommends a specific set of treatments that should begin within 1 hour of sepsis recognition. Under the care guidelines, arrival at triage acts as the “timestamp” from which the 1-hour treatment directive should commence.1
However, these guidelines may lead to misdiagnosis and inappropriate treatment by overburdened ED staff. In an editorial published in Annals of Emergency Medicine, Spiegel and colleagues argued that there is insufficient evidence to prove that 1-hour care bundles are associated with improved patient outcomes.1 Further, the new SSC care bundle created logistic challenges for many ED, which may delay care and put patients at a higher risk for medical complications.
Understanding the SSC 1-Hour Care Bundle
- The updated SSC 1-hour care bundle includes recommendations for:2
- Measuring lactate level and re-measuring lactate if initial lactate is elevated (>2 mmol/L).
- Obtaining blood cultures before administering antibiotics.
- Administering broad-spectrum antibiotics.
- Rapid administration of 30 mL/kg crystalloid for hypotension or lactate level is 4 mmol/L or higher.
- Applying vasopressors if a patient is hypotensive during or after fluid resuscitation to maintain a mean arterial pressure of 65 mm/Hg or higher.
These guidelines represent a significant departure from previous care bundles, which allowed for 3-hour and 6-hour treatment directives.
Researchers acknowledged that the intentions in creating the new guidelines were appropriate: patients presenting with symptoms of sepsis require prompt medical evaluation, and the 1-hour care bundle aims to shorten the time between diagnosis and treatment. The researchers further recognized that rapid interventions for sepsis patients allow for improved survival rates and better treatment outcomes. However, there are several crucial limitations in the 1-hour care bundle, which may present a serious risk to certain patients and can affect the functionality of an ED.
1-Hour Care Bundles May Increase the Risk for Misdiagnosis and Overtreatment
The stress placed on ED staff in attempting to follow a 1-hour protocol may result in sepsis risk being inaccurately assessed during triage. Diagnoses of sepsis and septic shock often require an evaluation from an experienced ED clinician, however time constraints may result in triage nurses being tasked with identifying patients who are at risk for sepsis instead. This may allow for a significant percentage of patients to be categorized, inaccurately, as potential cases of sepsis.
The greater the pressure on ED staff to identify all possible sepsis cases, the greater the risk for misdiagnosis and unnecessary treatment. Researchers argued that, “…by examining only the patients later determined to have sepsis, the [SSC guideline] authors ignored patients without sepsis who were exposed to the risks associated with broad-spectrum antibiotics and large-volume fluid resuscitation.”1
The Complex Temporal Link Between Intervention and Patient Outcomes
Patients in the early stages of sepsis may not require immediate treatment; conversely suboptimal treatment of sepsis can be fatal. The researchers contended that it is vital to begin treatment at the correct time, noting the fine line between administering antibiotics too early and too late. For many patients, the previous 3-hour and 6-hour care bundles are sufficient to prevent life-threatening complications.1
Researchers of the SSC guidelines may “assume that all earlier treatment is better; in this case, [that] a 1-hour bundle is superior to 3- and 6-hour bundles from previous guidelines.”1 However, this assumption regarding the temporal link between administration of treatment and patient outcomes is rooted in data sets which provide only one piece of the puzzle.
Patients from referenced data sets often received intervention only after a displaying “clear start signal” of sepsis, such as septic shock.3 Researchers noted that these data sets offer “no ability to detect the granular differences that [interventions that require] 1 hour vs 3 to 6 hours to complete makes on overall care”.1
Researchers further noted that “the only prospective randomized controlled trial evaluating early antibiotics administration in an undifferentiated cohort of patients with suspected infection found no benefit.”1 The most-ill patients, including those experiencing septic shock, are those who benefit most from prompt medical intervention. However, patients who are not experiencing sepsis complications and who may, in fact, not have sepsis do not seem to benefit from aggressive care; overtreatment, may, in fact, put these patients at risk.
1-Hour Care Bundles May Place a Heavy Burden on EDs
Three-hour care bundles presently place a heavy burden on overcrowded hospitals. ED staff may struggle to perform medical evaluations and begin appropriate care within such a limited time frame. If ED staff are pressured to start treatment for suspected sepsis cases within 1 hour, many patients will receive unnecessary care. For example, some ED staff may decide the approach dictates that interventions begin as soon as possible for any patients showing symptoms of infection, even if symptoms of septic shock are not present.
The resources needed to obtain blood cultures or start antibiotics for a large number of patients may also delay other forms of care. As each ED has a limited amount of resources available at a given time, aggressive sepsis detection measures may delay treatment for some patients. The SSC guidelines “lay a heavy weight on ED care, absent evidence that a net benefit will follow.”1
Sepsis Care Specifics vs Quality of Care
Researchers examined the results of several recent sepsis trials that indicated early and ongoing care by clinicians improves treatment outcomes. However, the results of a metanalysis of these trials suggested that care specifics may be less important than the quality of care itself.4 Researchers remarked that “good care can happen in many forms,”1 noting that an individual clinician’s judgment is often sufficient to determine when it is necessary to begin care for a potential sepsis case.
Researchers also highlighted the results of a comprehensive 12-year study in Australia and New Zealand that examined patients with severe sepsis and septic shock. This study documented a 16.6% reduction in patient mortality, although the region did not endorse bundled care measures.5 This study provided evidence that quality care and sound clinical judgment are of greater value that broadly-implemented care guidelines.
Further, researchers noted that bundling care measures suggests that all components are equally important; however, the evidence does not support this. In many studies, the effects of prompt administration of antibiotics were determined to be equivalent to the effects produced by the completion of the entire care bundle.3 Researchers concluded that “[o]nly antibiotic use was consistently associated with these improved outcomes.”1
The administration of fluid bolus appears less vital as well. Certain studies have indicated that early fluid boluses may cause harm to some adult patients presenting with septic shock. Researchers asserted that clinician judgment is essential for determining when fluid boluses are appropriate; administering fluid boluses to all suspected sepsis cases may put some patients at risk.
The Effect of 1-Hour Care Bundles on Potential Sepsis Patients
After examining the data sets, researchers concluded that there is insufficient evidence supporting a net benefit from the restriction on the time allowed for identification and treatment of sepsis. Instead, some patients may be more likely to experience an adverse outcome by unnecessarily aggressive care. In addition, imposing an hour-long window increased ED costs and logistical challenges.
A better approach, researchers argued, would “concentrate on identifying the subgroup of patients who will benefit from timely, appropriate care.”1 Emergency medicine clinicians are best qualified to perform these tasks through ongoing exams and observations, independent of arbitrary timestamps or broad guidelines.
1 Spiegel R, Farkas JD, Rola P, et al. The 2018 Surviving Sepsis Campaign’s Treatment Bundle: When Guidelines Outpace the Evidence Supporting Their Use. Annals of Emergency Medicine. 2019;73(4):356-358.
2 Levy MM, Evans LE, Rhodes A. The Surviving Sepsis Campaign Bundle. Critical Care Medicine. 2018;46(6):997-1000.
3 Seymour CW, Gesten F, Prescott HC, et al. Time to Treatment and Mortality during Mandated Emergency Care for Sepsis. New England Journal of Medicine. 2017;376(23):2235-2244.
4 Rowan KM, Angus DC, Bailey M, et al. Early, Goal-Directed Therapy for Septic Shock — A Patient-Level Meta-Analysis. New England Journal of Medicine. 2017;377(10):994-995
5 Kaukonen K-M, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality Related to Severe Sepsis and Septic Shock Among Critically Ill Patients in Australia and New Zealand, 2000-2012. JAMA. 2014;311(13):1308.