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Changing Definition of Sepsis- New
Inroads
Dr Neisevilie Nisa
All India Institute of Medical Sciences
Why sepsis again..?
• Its magnitude on public health
• $20 billion of total US hospital cost 2011 (Torio et al)
• $2000 cr...
The need to upgrade definitions…
“To know what distinguishes sepsis from an
uncomplicated infection”
“…. We need to differ...
Old definition and its limitation
1991 consensus conference (Sepsis-1)
• Introduced SIRS (Systemic Inflammatory
response s...
2001 Task Force (Sepsis-2)
• Expanded the list of diagnostic criteria
• No other alternatives offered due to lack of
evide...
The validity of SIRS challenged…
• Are all infection sepsis…?
• Which kind of infection leads to sepsis…?
• Uncertain path...
Developing new definitions
• European Society of Intensive Care Medicine
• Society of Critical Care Medicine
“ Shift of fo...
New definitions
• Sepsis: A life-threatening organ dysfunction caused by a
dysregulated host response to infection.
• Sept...
Criteria for new definitions
• SOFA score ≥ 2 points consequent to the infection.
• Baseline SOFA score is assumed to be z...
Evidence behind SOFA score
Two outcomes:
1) Hospital mortality
1) ICU stay of 3 days or longer
Consort diagram
ICU encounters (n=7932)
Non-ICU encounters (n=66522)
SOFA and LODS superior to SIRS with higher
Predictive Validity to represent organ dysfunction
Limitations of SOFA
• Cumbersome due to multiple variables
• Not well known outside ICU setting
• Variables and cutoff val...
Quick SOFA( q SOFA) Seymor et al
Early Screening for Performance Improvement
Parameters Criteria
Respiratory rate ≥22/min
...
q SOFA ≥ 2 Predictive validity outside ICU setting = 81 %
Evidence of q SOFA
• Poor man’s SOFA
• Quick and repeat bedside test
• No laboratory test required
– Outside ICU settings
...
Changing definition of Septic Shock
• First Consensus Definitions in 1991 and revisited
in 2001
Septic shock defined as a ...
• Meta-analysis and systemic reviews from
January 1, 1992- December 25,2015
• 44 septic shock studies
• 166,479 patients
Three variables identified
• Hypotension
• Elevated serum lactate level
• Sustained need for vasopressor therapy
Mortality significantly higher (p< .001) in patients
with fluid resistant hypotension requiring
vasopressors and hyperlact...
Lactate > 2 mmol/L for predicting mortality in Septic Shock
Sensitivity = 82.5 %
Specificity = 22.4 %
New definition of Septic shock
• A clinical construct of sepsis with persisting
hypotension requiring vasopressors to main...
How it differs from old definition..??
• Both serum lactate level and vasopressor-
dependent hypotension instead of either...
Summary
• Sepsis: A life-threatening organ dysfunction caused by a
dysregulated host response to infection.
• SOFA score ≥...
• Septic shock: Sepsis in which underlying circulatory and
cellular/metabolic abnormalities are profound enough to
substan...
Operationalization of Clinical Criteria
Controversies and limitations
• Most data extracted from US databases
• q SOFA and SOFA can miss occult organ dysfunction
...
Conclusion
It took us more than 10 years to understand sepsis, now we
will have to change it all….
“…. Is it the final wor...
Thank you
References
• Torio CM, Andrews RM. National inpatient hospital costs: the most expensive conditions
by payer, 2011. Statis...
New definition of sepsis... sepsis 3
New definition of sepsis... sepsis 3
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New definition of sepsis... sepsis 3

  1. 1. Changing Definition of Sepsis- New Inroads Dr Neisevilie Nisa All India Institute of Medical Sciences
  2. 2. Why sepsis again..? • Its magnitude on public health • $20 billion of total US hospital cost 2011 (Torio et al) • $2000 crore = Rs 1,33,944 crores • 3.97 % of GDP 2013 = Rs 33,150 crore • AIIMS budget = Rs 1,340 crore (2013-14)
  3. 3. The need to upgrade definitions… “To know what distinguishes sepsis from an uncomplicated infection” “…. We need to differentiate a straight forward infection from one that can cause organ dysfunction or death…….”
  4. 4. Old definition and its limitation 1991 consensus conference (Sepsis-1) • Introduced SIRS (Systemic Inflammatory response syndrome) • Sepsis complicated by organ dysfunction= severe sepsis • Septic shock= Sepsis induced hypotension persistent despite adequate fluid resuscitation
  5. 5. 2001 Task Force (Sepsis-2) • Expanded the list of diagnostic criteria • No other alternatives offered due to lack of evidence • Definitions have remained unchanged for more than 2 decades
  6. 6. The validity of SIRS challenged… • Are all infection sepsis…? • Which kind of infection leads to sepsis…? • Uncertain pathobiology • No gold standard diagnostic test • Poor Discriminant Validity • Poor Concurrent Validity • SIRS criteria have been used to diagnose sepsis for more than 20 years. • “SIRS no longer has any legs….. it sounded like a good idea in 1992, but it has lost steam….”
  7. 7. Developing new definitions • European Society of Intensive Care Medicine • Society of Critical Care Medicine “ Shift of focus from Inflamation to Organ Dysfunction”
  8. 8. New definitions • Sepsis: A life-threatening organ dysfunction caused by a dysregulated host response to infection. • Septic shock: Sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality. • Terms like severe sepsis/ septicemia removed
  9. 9. Criteria for new definitions • SOFA score ≥ 2 points consequent to the infection. • Baseline SOFA score is assumed to be zero • SOFA score ≥ 2 overall mortality risk 10%
  10. 10. Evidence behind SOFA score Two outcomes: 1) Hospital mortality 1) ICU stay of 3 days or longer
  11. 11. Consort diagram
  12. 12. ICU encounters (n=7932)
  13. 13. Non-ICU encounters (n=66522) SOFA and LODS superior to SIRS with higher Predictive Validity to represent organ dysfunction
  14. 14. Limitations of SOFA • Cumbersome due to multiple variables • Not well known outside ICU setting • Variables and cutoff values were developed by consensus
  15. 15. Quick SOFA( q SOFA) Seymor et al Early Screening for Performance Improvement Parameters Criteria Respiratory rate ≥22/min Altered mentation GCS <13 Systolic blood pressure ≤100mmHg
  16. 16. q SOFA ≥ 2 Predictive validity outside ICU setting = 81 %
  17. 17. Evidence of q SOFA • Poor man’s SOFA • Quick and repeat bedside test • No laboratory test required – Outside ICU settings – Emergency – Wards Predictive validity outside ICU setting = 81 % Remarkable 3 vital signs model returning results with a model that has multiple lab test (SOFA)
  18. 18. Changing definition of Septic Shock • First Consensus Definitions in 1991 and revisited in 2001 Septic shock defined as a state of cardiovascular dysfunction associated with infection and unexplained by other causes • No differentiation between Septic Shock and Cardiovascular Dysfunction • To recognize the importance of Cellular Abnormalities
  19. 19. • Meta-analysis and systemic reviews from January 1, 1992- December 25,2015 • 44 septic shock studies • 166,479 patients
  20. 20. Three variables identified • Hypotension • Elevated serum lactate level • Sustained need for vasopressor therapy
  21. 21. Mortality significantly higher (p< .001) in patients with fluid resistant hypotension requiring vasopressors and hyperlactatemia (42.3 %) ‘VS’ Hyperlactatemia alone “or” Fluid resistant hypotension requiring vasopressors but Lactate level ≤ 2 mmol/L (30.1%)
  22. 22. Lactate > 2 mmol/L for predicting mortality in Septic Shock Sensitivity = 82.5 % Specificity = 22.4 %
  23. 23. New definition of Septic shock • A clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP 65mmHg and having a serum lactate level >2 mmol/L (18mg/dL) despite adequate volume resuscitation • With these criteria, hospital mortality is in excess of 40% A subset of sepsis in which underlying circulatory and cellular metabolism abnormalities are profound enough to substantially increase mortality
  24. 24. How it differs from old definition..?? • Both serum lactate level and vasopressor- dependent hypotension instead of either alone • Lower serum lactate level cutoff of 2 mmol/L vs 4 mmol/L as currently used in the SSC definitions • Fewer patients will be diagnosed, but a more robust characterization • More precise diagnosis • Better epidemiological tracking
  25. 25. Summary • Sepsis: A life-threatening organ dysfunction caused by a dysregulated host response to infection. • SOFA score ≥ 2 points = Organ Dysfunction • SOFA score to evaluate sepsis in ICU settings • q SOFA score to evaluate sepsis outside the ICU
  26. 26. • Septic shock: Sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality. • Terms like severe sepsis/ septicemia removed
  27. 27. Operationalization of Clinical Criteria
  28. 28. Controversies and limitations • Most data extracted from US databases • q SOFA and SOFA can miss occult organ dysfunction • Specific infections can cause local organ dysfunction without dysregulated systemic host response • Non-availability of lactate measurements in resource poor settings • Task force focused on adult patients
  29. 29. Conclusion It took us more than 10 years to understand sepsis, now we will have to change it all…. “…. Is it the final word in sepsis..?... Or the starting point of discussion and additional research into this deadly condition……”
  30. 30. Thank you
  31. 31. References • Torio CM, Andrews RM. National inpatient hospital costs: the most expensive conditions by payer, 2011. Statistical Brief #160. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs.August 2013.Accessed October 31, 2015 • Bone RC, Balk RA, Cerra FB, et al. American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med.1992;20(6):864- 874. • Levy MM, Fink MP, Marshall JC, et al;International Sepsis Definitions Conference. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Intensive Care Med. 2003;29(4):530-538. • Seymour CW, Liu V, Iwashyna TJ, et al Assessment of clinical criteria for sepsis. JAMA. Doi: 10.1001/jama.2016.0288. • 13. Shankar-HariM, Phillips G, LevyML, et al Assessment of definition and clinical criteria for septic shock. JAMA.doi:10.1001/jama.2016.0289 • Singer M, Deutschman CS, Seymour CW, et al.The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA.doi:10.1001/jama.2016.0287.
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Sepsis 3.... the new guidelines in SEPSIS , SOFA score, Quick SOFA acore,

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