Why All the Drama About the New Definition for Sepsis?

Aaron B. Holley, MD


August 02, 2016

New Sepsis Consensus Prompts Strong Reactions

I have to admit that I missed the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) published in JAMA[1] earlier this year. What I didn't miss were several negative editorials published in the months following the sepsis statement release. Guidelines can have widespread implications for clinical care, research, and reimbursement, so controversy among different stakeholders is inevitable. That said, I was surprised at the backlash I saw in quality journals that publish for the critical care community.

Replace SIRS With SOFA

So what do the guidelines actually say? To start, they advise us to abandon the systemic inflammatory response syndrome (SIRS) criteria that we have been using to define sepsis since 1991.[2] They recommend that the Sequential Organ Failure Assessment (SOFA)[3] be used instead to define sepsis.

Recognizing that SOFA requires laboratory values and is complicated to calculate, the statement authors suggest using the quick SOFA (qSOFA) in lieu of the full score. Patients are considered qSOFA-positive when they meet two of the following three criteria:

  • Glasgow Coma Score < 15 (which means any alteration in mentation);

  • Respiratory rate ≥ 22 breaths/min; or

  • Systolic blood pressure ≤ 100 mm Hg.

The qSOFA doesn't perform as well as the full SOFA score in the intensive care unit setting, but it is superior to SOFA when applied to patients outside of the intensive care unit.[4]

Sepsis-3 also does away with the term "severe sepsis" and standardizes the meaning of septic shock. The authors saw no reason for the category of severe sepsis because their working definition for the syndrome of sepsis requires organ dysfunction. Organ dysfunction is a part of what distinguishes sepsis from simple infection. Sepsis-3 criteria for septic shock require measurement of lactate and the requirement for vasopressors to maintain a mean arterial blood pressure ≥ 65 mm Hg after failure to respond to fluid therapy.[5]

Experts Weigh In

The accompanying editorial, in the same JAMA issue,[6] was measured in its assessment of Sepsis-3. The author agreed that SIRS should be abandoned, but claims that the qSOFA lacks prospective validation and shouldn't be used until said validation is obtained.

The author also observes that the large data sets used to support the new criteria only include adult patients from high-income countries. We don't know whether Sepsis-3 will perform well in low-income areas or in younger patients.

Finally, the editorialist laments the lack of progress toward identifying sepsis phenotypes that might respond to individualized therapies.[6]

The editorials in other journals weren't as kind. A simple look at their titles speaks volumes: "New Sepsis Criteria: A Change We Should Not Make"[7]; "Defining Sepsis: A Case of Bounded Rationality and Fuzzy Thinking?"[8]; and "Change Is Not Necessarily Progress: Revision of the Sepsis Definition Should Be Based on New Scientific Insights."[9]

The author of the first editorial, published in CHEST, is concerned that the new guidelines sacrifice sensitivity for the sake of specificity. The implementation of the guidelines risks identification of sepsis at a later point in the disease process, when it is less amenable to treatment. He also worries that new criteria will be difficult to implement.[7]

The second editorialist takes issue with the approach to defining sepsis and suggests that we would be better off accepting uncertainty across multiple domains.[9]

The last editorial expressed concerns similar to the first—that the new guidelines will hinder early identification of sepsis. These authors also state that the sepsis field hasn't seen any scientific breakthroughs that would mandate revising a definition that has stood for 20 years. The SIRS, severe sepsis, and septic shock criteria are integrated in clinical trials, and quality improvement mandates and shouldn't be changed arbitrarily. In short, the Sepsis-3 investigators haven't made the case that change is justified.[9]

An Inevitable Compromise

Rivers and colleagues' study[10] on early goal-directed therapy was published during my intern year. If nothing else, that study highlighted the importance of early sepsis identification. Over the years, I have accepted the importance of sacrificing specificity in exchange for early diagnosis. As an intensivist, I would prefer "bogus admits" for possible sepsis to those with organ failure and a high mortality rate. There is usually little that we can do for the latter group.

In short, I find myself in agreement with the critics. If the qSOFA is prospectively validated and proves to have either superior sensitivity or comparable sensitivity with improved specificity, I would be all for adopting the Sepsis-3 criteria. Until then, I see no compelling reason for change.

As for the Sepsis-3 definition of septic shock, I have no objections. It seems that the rationale here is to enforce a specific standard rather than recommend a change. It is important that researchers, clinicians, and payers speak the same language. Lactate elevation, a lack of response to fluids, and need for vasopressor are included in existing definitions,[4] so there shouldn't be much debate here.


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