Although the Infectious Diseases Society of America (IDSA) commends the Centers for Medicare & Medicaid Services (CMS) for emphasizing the importance of improving sepsis management and outcomes with the implementation of the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), IDSA has outlined several recommendations aimed at reducing the risk for unintended consequences of SEP-1 in a position paper published in Clinical Infectious Diseases.

IDSA has recommended that sepsis without shock be removed from SEP-1, because the evidence supporting the effect of immediate antibiotics on survival is strong for septic shock and weak for sepsis without shock. Focusing SEP-1 on septic shock alone will mitigate the risk for unnecessary antibiotic prescribing for noninfectious syndromes, simplify data abstraction, increase measure reliability, and focus attention on the people most likely to benefit from immediate empiric broad-spectrum antibiotics.

IDSA is concerned about the reliability of SEP-1 abstraction in view of its complicated rules for identifying a time zero. They also recommend that the systemic inflammatory response syndrome (SIRS) criteria be eliminated, since shock and suspected infection are sufficient evidence of septic shock. In addition, they noted that limiting SEP-1 to septic shock alone would also simplify the time zero abstraction by eliminating the heterogeneous and complicated organ dysfunction criteria required to identify sepsis without shock. IDSA did not have a firm recommendation for defining septic shock time zero and noted that precise time zero definition warrants discussion with other expert task forces.

IDSA agreed that obtaining blood cultures before antibiotics should remain part of SEP-1, because positive blood cultures facilitate targeted, pathogen-specific therapy and antibiotic de-escalation, which may result in fewer adverse effects and faster recovery. Rather than 3 hours, however, IDSA recommended administering antibiotics within an hour of septic shock recognition, given the urgency and benefit of immediate antibiotics in this population. They added that SEP-1 should require hospitals to report time interval between antibiotic order and delivery for the first broad-spectrum antibiotic, since this can help hospitals to provide timely care and drive improvements in their drug delivery systems.


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Because defining septic shock as persistent hypotension after 30 cc/kg of fluids is not evidence-based and difficult to abstract, IDSA recommended that this measure be modified to a more objective and reproducible clinical criteria. In addition, they recommended that lactate measurements be removed from SEP-1, because there is no clear evidence of clinical benefit. Although lactate values can provide important clinical information in certain patients, “guidance on the appropriate role of lactate testing in sepsis diagnosis, risk stratification, and resuscitation is nuanced and, thus, better left to clinical discretion informed by clinical guidelines rather than compelled by a single, homogeneous quality measure for all patients,” they noted.

Although national quality measures have the potential to substantially improve patient outcomes, “they should be limited to clearly beneficial interventions with strong supporting evidence while being attentive to the possibility of unintended, harmful consequences,” concluded the researchers.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Rhee C, Chiotos K, Cosgrove SE, et al. Infectious Diseases Society of America position paper: recommended revisions to the national severe sepsis and septic shock early management bundle (SEP-1) sepsis quality measure [published online May 6, 2020]. Clin Infect Dis. doi:10.1093/cid/ciaa059