Critical Care Commentary

The 1-hour sepsis bundle is serious—serious like a heart attack


 

In 2002, the European Society of Intensive Care Medicine, the Society of Critical Care Medicine, and the International Sepsis Forum formed the Surviving Sepsis Campaign (SSC) aiming to reduce sepsis-related mortality by 25% within 5 years, mimicking the progress made in the management of STEMI (http://www.survivingsepsis.org/About-SSC/Pages/History.aspx).

SSC bundles: a historic perspective

The first guidelines were published in 2004. Recognizing that guidelines may not influence bedside practice for many years, the SSC partnered with the Institute for Healthcare Improvement to apply performance improvement methodology to sepsis management, developing the “sepsis change bundles.” In addition to hospital resources for education, screening, and data collection, the 6-hour resuscitation and 24-hour management bundles were created. Subsequent data, collected as part of the initiative, demonstrated an association between bundle compliance and survival.

Dr. Amit Uppal

In 2008, the SSC guidelines were revised, and the National Quality Forum (NQF) adopted sepsis bundle compliance as a quality measure. NQF endorsement is often the first step toward the creation of mandates by the Centers for Medicare and Medicaid Services (CMS), but that did not occur at the time.

In 2012, the SSC guidelines were updated and published with new 3- and 6-hour bundles. That year, Rory Staunton, an otherwise healthy 12-year-old boy, died of septic shock in New York. The public discussion of this case, among other factors, prompted New York state to develop a sepsis care mandate that became state law in 2014. An annual public report details each hospital’s compliance with process measures and risk-adjusted mortality. The correlation between measure compliance and survival also holds true in this data set.

In 2015, CMS developed the SEP-1 measure. While the symbolic importance of a sepsis federal mandate and its potential to improve patient outcomes is recognized, concerns remain about the measure itself. The detailed and specific way data must be collected may disconnect clinical care provided from measured compliance. The time pressure and the “all-or-nothing” approach might incentivize interventions potentially harmful in some patients. No patient-centered outcomes are reported. This measure might be tied to reimbursement in the future.

The original version of SEP-1 was based on the 2012 SSC bundles, which reflected the best evidence available at the time (the 2001 Early Goal-Directed Therapy trial). By 2015, elements of that strategy had been challenged, and the PROCESS, PROMISE, and ARISE trials contested the notion that protcolized resuscitation decreased mortality. Moreover, new definitions of sepsis syndromes (Sepsis-3) were published in 2016 (Singer M, et al. JAMA. 2016;315[8]:801).

The 2016 SSC guidelines adopted the new definitions and recommended that patients with sepsis-induced hypoperfusion immediately receive a 30 mL/kg crystalloid bolus, followed by frequent reassessment. CMS did not adopt the Sepsis-3 definitions, but updates were made to allow the clinicians flexibility to demonstrate reassessment of the patient.

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