Wait, is this sepsis?
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1 Wait, is this sepsis? Reconciling Disparate Sepsis Definitions LAURA QUINNAN, M.D. NWH SEPSIS COMMITTEE CO-CHAIR, CHIEF OF MEDICINE AND MEDICAL DIRECTOR OF HOSPITALIST TEAM Goals Describe Sepsis-3 definitions Describe Limitations of Sepsis-3 definitions Explain areas of conflict with Sepsis-2 definitions and definitions used in the Sep-1 quality measure Review suggested approach to apply definitions 1
2 Sepsis - life threatening organ dysfunction caused by a dysregulated host response to infection. No current clinical measures reflect the concept of a dysregulated host response. There are no simple and unambiguous clinical criteria or biological, imaging, or laboratory features that uniquely identify a septic patient. Identifying sepsis LARGE retrospective analysis of patients with suspected infection performed (148,907 patients in PA, 700,000 more worldwide) comparing ability of SIRS v SOFA v LODS to identify risk of 1 yr mortality, hospital mortality and ICU stay >3 days. SOFA and LODS performed better than SIRS. They decided use SOFA, because it was more common (as a mortality predictor) and simpler 2
3 6/4/2018 SOFA Calculator qsofa 3
4 Septic Shock Subset of sepsis in which the underlying circulatory and cellular metabolic abnormalities are profound enough to substantially increase mortality. Identified by persistent hypotension following fluid bolus AND LA >2 (BOTH TOGETHER) With use of SOFA criteria, anticipated mortality of Sepsis is 10% and Septic Shock 40% Other key points SIRS Criteria - helpful in identifying patients with infection, but unhelpful in defining sepsis. SIRS was, thus, dropped from the new definition of sepsis. Since all sepsis is severe based on the new definition, removal of the term Severe Sepsis was recommended. 4
5 6/4/2018 Operationalization of Clinical Criteria Caveats Neither qsofa nor SOFA is intended to be a stand-alone definition of sepsis. The SOFA score is not intended to be used as a tool for patient management but as a means to clinically characterize a septic patient. (epidemiologic and investigative implications) 5
6 May ACCP Position Concern about application of these definitions prospectively. (Does the development of a framework based on retrospective data accurately identify the patients at highest risk, when it doesn t take into account the risk mitigate by appropriate early treatment?) Cautioned against adoption of these definitions without prospective validation CCM Moskowitz et al. Compared SIRS and qsofa at ability to identify patients that required ICU admission for treatment of their infection. qsofa score % of patients received critical care & 6.1% died Although a qsofa of <2 is characterized as low risk, this study suggests that a very significant & severe burden of disease exists in patients that would not meet this threshold. when qsofa 2 was measured at triage, it was only 13% predictive of need for critical care interventions. Thus, relying on qsofa score at a crucial decision making time is likely to miss the majority of severely ill, septic patients. 6
7 6/4/2018 Observational cohort study compared qsofa with other warning scores in predicting death or ICU transfer. Less than one in five patients that go on to die or be transferred to the ICU will have met 2 qsofa criteria by the time of infection suspicion. Most patients who met the composite outcome met 2 SIRS criteria more than 17 hours before the composite outcome compared with only 5 hours for 2 qsofa, with almost half of the patients still not meeting 2 qsofa criteria at the time of outcome. Positive qsofa may be an insensitive, late indicator of severe disease Chest Editorial It is not at all clear that prolonged ICU stay or mortality are the correct end points on which to base diagnostic criteria. Death and prolonged ICU stay are end points that all physicians should be striving to prevent, and the clear purpose of diagnostic criteria is to prompt physicians to intervene, not merely to classify disease. Given that sepsis does exist on a continuum of disease severity, it is an odd step to settle on a diagnostic system that fails to recognize or even attempt to recognize the condition at its earlier phases when it is most treatable. 7
8 Con t The lexicon of sepsis is one of our most important tools in the fight to have more providers at every level engaged in keeping infected patients alive, and this is the most compelling reason for SIRS to remain a part of that lexicon. The language we use shapes the way we think and the way we act. Contrary to the Sepsis-3 authors unanimous opinion that SIRS is unhelpful in the diagnosis of sepsis, using such an approach to prompt therapy is effective in reducing mortality. That fact, alone should command the retention of SIRS in the diagnosis and language of sepsis. Sepsis - UW Enterprise Position Supports the Sepsis-3 definition, that sepsis is life threatening organ dysfunction caused by a dysregulated host response to infection. We do not support the strict application of qsofa & SOFA criteria. We agree with the statement from the Sepsis Definitions Task Force members that, there are no simple and unambiguous clinical criteria or biological, imaging, or laboratory features that uniquely identify a septic patient. Organ dysfunction is the temporary or permanent abnormal functioning of an organ system that is thought to be related to a suspected infection. We also feel that a provider s assessment of significant risk of ICU transfer or death can be a surrogate of organ dysfunction. 8
9 6/4/2018 Septic Shock UW Enterprise Position Supports the idea put forth by the Sepsis-3 task force that septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality. We do not believe that this population is limited to patients with both hypotension AND hyperlactatemia. Patients with severely elevated lactic acid levels, or persistent hypotension with or without the use of vasopressors all have a mortality risk which is markedly higher than patients with sepsis alone, and should, thus, also be considered a part of this subset. 9
10 What about Severe Sepsis? Hospital sepsis mortality is calculated based on severe sepsis and septic shock patients, thus eliminating this diagnosis will lead to an unfair comparison with other hospitals Sep-1 Quality Measure still uses Severe Sepsis to determine whether a patient requires specific interventions. Eliminating this term may make us more prone to miss required interventions. Affect on case mix index and thus reimbursement How does this mesh with the quality measure? Quality measure still uses Sepsis-2 definitions, with additional clarification of the lactate level that characterizes cryptic septic shock (initial LA >4) However, patients will not fall into the denominator unless we diagnose them with sepsis. i.e. If someone has SIRS and looks really non-toxic and you think they just have a UTI, they re not going to fall into the quality measure unless you state that sepsis is present. 10
11 Operationalizing this Continue to use SIRS (and also think about qsofa) when assessing an infected patient. I would consider 30 ml/kg and early abx in patients with 2 SIRS criteria or positive qsofa, but would DEFINITELY give these therapies to anyone meeting these criteria & appears to have organ dysfunction, significant risk of death or ICU transfer (which is to say anyone who has sepsis). Recommendations Use your clinical judgement about what constitutes a significant risk of ICU transfer or death when deciding if a patient has sepsis. DO NOT JUST GO BY A WEAKLY POSITIVE SET OF SIRS Don t abandon Severe Sepsis right now, because it does matter for administrative reasons Continue to use current septic shock criteria form the quality measure (persistent hypotension or initial LA >4) 11
12 Document to support your diagnosis YES patient appears toxic and tachypneic high grade fevers and tachypnea would not be expected for simple cellulitis Acute kidney injury is related to the severity of pneumonia and would not be expected for simple PNA alone No patient is septic based on positive SIRS criteria and UTI Well appearing man sitting comfortable in bed, NAD 12
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