Sepsis and Septic Shock: New Definitions for Adults

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1 PL Detail-Document # This PL Detail-Document gives subscribers additional insight related to the Recommendations published in PHARMACIST S LETTER / PRESCRIBER S LETTER April 2016 Sepsis and Septic Shock: New Definitions for Adults In January 2014, the Sepsis-3 task force assembled by the Society of Critical Care Medicine and the European Society of Intensive Care Medicine began examining the 2001 definition of sepsis and its related terms. The task force s new definitions for use in adults were published in early 2016, and have been endorsed by 31 medical associations. 1 The table below provides an overview of these new definitions and their clinical implications, in an FAQ format. The complete publication is available at What is the new definition of sepsis in adults? Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. 1 In lay terms, sepsis is a life-threatening situation where the body s response to infection is actually injuring the body. 1 Organ dysfunction is measured using the SOFA (Sequential Organ Failure Assessment). 1 The SOFA is recommended in the ICU setting. 1,2 An increase from baseline score of at least two points that may be attributed to the infection signals organ failure. 1 (The Surviving Sepsis Campaign states it is okay to use the criteria from their guidelines as an alternative. 5 ) Instructions for calculating the SOFA score are available in Table 1 at Not all the lab values in the SOFA must be assessed to see an increase in score of 2 points or more. The qsofa (Quick SOFA) is a bedside screening tool that can be used in patients with suspected infection in the non-icu setting, including the emergency department, to quickly assess for patients at higher risk of a poor outcome. 1,2 No labs are needed. Patients who meet two or three qsofa criteria may need further evaluation for organ dysfunction, intensification of treatment or monitoring, or transfer to critical care. 1 The qsofa = respiratory rate 22/min or greater, altered mental status, and systolic blood pressure 100 mmhg or lower. 1 The qsofa is not as robust as the SOFA in the ICU setting, but could be used when a quick bedside assessment is needed. 1 Sepsis in-hospital mortality is >10%. 1

2 (PL Detail-Document #320424: Page 2 of 5) What is the new definition of septic shock in adults? Septic shock is a severe type of sepsis wherein circulatory and cellular metabolism abnormalities are extreme and substantially increase the risk of death. 1 Patients with septic shock require vasopressors to keep MAP >65 mmhg despite fluid resuscitation. 1 They also have a serum lactate level >2 mmol/l (18 mg/dl). 1 In-hospital mortality is >40%. 1 What are the major changes in the definitions of sepsis and septic shock? Sepsis with organ dysfunction used to be called severe sepsis. Now, infection with organ dysfunction is sepsis. The term severe sepsis is no longer used. 1 Septic shock used to be a state of acute circulatory failure. The new definition of septic shock is broader, to separate sepsis from cardiovascular failure alone, to highlight the role of cellular dysfunction, and to differentiate septic shock from sepsis in regard to illness severity and mortality risk. 1 Why were new definitions of sepsis and septic shock developed? Medical advances have improved our understanding of sepsis since sepsis-related definitions were last developed. 1 Many sepsis-related terms were imprecise, or were being applied incorrectly (e.g., sepsis, severe sepsis, sepsis syndrome, septicemia, etc). 1 A definition that laypersons can understand is needed to help educate the public about sepsis so it can be recognized and treated early. 1 The previous definitions made it difficult to choose the correct ICD-9/ICD-10 code. 1 The old definitions focused on inflammation, not organ dysfunction, which seems to be a better predictor of mortality. 1 The old definitions presented sepsis as a continuum that starts with severe sepsis and progresses to shock. 1 New definitions that foster uniformity in diagnosis of sepsis for clinical research purposes are needed, so that incidence, morbidity, and mortality can be more precisely determined. 1 Currently, mortality figures vary four-fold among studies. 1 There is a need for definitions that use objective criteria that can be easily, quickly, and inexpensively measured and that identify all facets of sepsis (i.e., infection, response, organ dysfunction). 1 There is a need for definitions that help health professionals in all settings identify patients with lifethreatening infection, as data are accumulating that quick management may improve outcomes. 1

3 (PL Detail-Document #320424: Page 3 of 5) What are some practical implications of the new definitions for sepsis and septic shock? Consider organ dysfunction in any patient with known or suspected infection; organ dysfunction may not be clinically obvious. 1 Consider infection in any patient with newly identified organ dysfunction (e.g., two or more qsofa criteria). 1 The recommended primary ICD-10 codes for sepsis and septic shock are R65.20 and R65.21, respectively. 1 The SOFA and qsofa are not the final word on sepsis. Do not delay care (e.g., antibiotics, testing) if the patient does not meet SOFA or qsofa criteria but is still suspected to have infection. 1 The new definitions will not affect sepsis management. 1 However, they should help identify patients at highest risk of mortality, in whom an escalation of care should be considered. 1 It s too soon to know how Joint Commission and Centers for Medicare and Medicaid Services will respond to these changes. For now, continue to follow current quality measure sepsis bundles. Updated Surviving Sepsis Campaign guidelines are due to be published in late What is the difference between infection and sepsis? Organ dysfunction differentiates infection from sepsis. 1 What happened to the SIRS (systemic inflammatory response syndrome) criteria? SIRS criteria were developed based on the theory that sepsis was caused by an inflammatory response to infection. 1 SIRS is basically an infection with inflammatory response. 1 SIRS is defined as two or more of the following: temperature >38 o C or <36 o C, heart rate >90 beats per minute, respiratory rate >20/min or PaCO2 <32 mm hg [4.3 kpa], white count >12,000/mm3 or <4000/mm3 or >10% immature bands. 1 SIRS is not a specific or sensitive definition. 1 Patients can meet SIRS criteria without having organ dysfunction (i.e., SIRS is not always sepsis). 1 Patients meeting SIRS criteria may actually be having an appropriate response to infection. 1 Patients can even meet SIRS criteria without having an infection. 4 In fact, many hospitalized patients meet SIRS criteria. 4 SIRS criteria can still be used to help identify patients with infection. 1

4 (PL Detail-Document #320424: Page 4 of 5) How were the new definitions developed and validated? What are some drawbacks with these new definitions? A 19-member task force was appointed by the Society of Critical Care Medicine and the European Society of Intensive Care Medicine. 3 A systematic review and meta-analysis was performed on studies from 1992 to 2015 to identify criteria used to define septic shock. 3 The results of the systematic review and cohort studies were considered by the task force. 3 A Delphi process (surveys, discussion) was used to reach consensus on a new definition. 3 The new definition was tested by applying it to several U.S. cohorts, and the Surviving Sepsis Campaign registry. 3 Patients with both elevated lactate and hypotension requiring vasopressors have significantly higher riskadjusted mortality than other patients; therefore, both were included in the definition of septic shock to differentiate it from sepsis. 3 A retrospective cohort of hospitalized adults with suspected infection was used to validate the SOFA and qsofa scores. 2 The SOFA score was better able to predict mortality than SIRS criteria in the intensive care setting. 2 The qsofa was superior to SIRS criteria and SOFA score in the non-icu setting. 2 The definitions have not been prospectively validated. 1 The definitions need to be validated in a broader population (e.g., non-u.s. hospitals, resource-poor areas). 1 The definitions are too broad to inform care for specific infections/patients. 4 The definitions are not for use in pediatric patients. 1 Users of this PL Detail-Document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national organizations. Information and internet links in this article were current as of the date of publication.

5 (PL Detail-Document #320424: Page 5 of 5) Project Leader in preparation of this PL Detail- Document: Melanie Cupp, Pharm.D., BCPS References 1. Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016;315: Seymour CW, Liu VX, Iwashyna TJ, et al. Assessment of clinical criteria for sepsis: for the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016;315: Shankar-Hari M, Phillips GS, Seymour CW, et al. Developing a new definition and assessing new clinical criteria for septic shock: for the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016;315: Abraham E. New definitions for sepsis and septic shock: continuing evolution but with much still to be done. JAMA 2016;315: Surviving Sepsis Campaign. Surviving Sepsis Campaign responds to Sepsis-3. March 1, nts/ssc-statements-sepsis-definitions pdf. (March 23, 2016). Cite this document as follows: PL Detail-Document, Sepsis and Septic Shock: New Definitions for Adults. Pharmacist s Letter/Prescriber s Letter. April Evidence and Recommendations You Can Trust 3120 West March Lane, Stockton, CA ~ TEL (209) ~ FAX (209) Copyright 2016 by Therapeutic Research Center Subscribers to the Letter can get PL Detail-Documents, like this one, on any topic covered in any issue by going to or