Steps to Success in Sepsis ASHNHA Quality Webinar. Maryanne Whitney, RN, CNS, MSN Improvement Advisor, Cynosure Health

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1 1 Steps to Success in Sepsis ASHNHA Quality Webinar Maryanne Whitney, RN, CNS, MSN Improvement Advisor, Cynosure Health

2 Goals for Today State the Problem: Create Awareness & Will Unravel the mysteries of Sepsis 2 vs Sepsis 3 Describe what has changed Describe what has NOT changed But neither SIRS nor qsofa are as specific as we would like what do we do? The status of fluid resuscitation in 2018 Identify areas to improve

3

4 Sepsis Remains a Killer in our Midst

5 Severe Sepsis: A Significant Healthcare Challenge Hospitalizations have doubled Most costly reason for hospitalization in billion in aggregate hospital cost 1 out of 23 patients in hospital had septicemia Major cause of morbidity and mortality worldwide Leading cause of death in non-coronary ICU 10th leading cause of death overall In the US, more than 700 patients die of severe sepsis daily (1.6 million new cases per year) 1 DEATH EVERY 2 MINUTES

6 The # 1 Cause of Inpatient Death The same pattern in every hospital

7 Anchorage Hospitals Sepsis Mortality Rates

8 Alaska Sepsis Mortality Reduction,

9 Severe Sepsis vs Other Disease Priorities Care Priorities U.S. Incidence # of Deaths Mortality Rate AMI 900, ,000 25% Stroke 700, ,500 23% Trauma 2.9 million 42, % (Motor Vehicle) (injuries) Severe Sepsis 751, ,000 29%

10 Critical Actions The Keys to achieving a reduction in mortality from severe sepsis are Early Recognition & Evidence Based Treatment. BOTH MUST occur.

11 The Pieces You Need Standard & Clear Definitions Drive recognition and treatment Early Recognition ED Inpatient and ICU Change the Culture Alerts Technology Make Early Treatment Easy Automatic, Protocols Bundle interventions

12 Definitions Drive Treatment Infection or trauma SIRS Systemic Inflammatory Response Syndrome Sepsis 2 or more SIRS + Infection Severe Sepsis Sepsis + s/s of organ dysfunction Septic Shock Refractory Hypotension +/or lactate >= 4 Sepsis is a Continuum

13 Standard Definitions SIRS: Systemic Inflammatory Response Syndrome Temp<36 C or >38 C, Heart Rate >90/min, Respiratory Rate >20/min or PaCO2 32mmHg, WBC <4,000 or >12,000 or 10% bands. Sepsis: presence of infection (suspected or confirmed) with systemic manifestations of infection Severe Sepsis: Sepsisinduced tissue hypoperfusion or organ dysfunction Neuro decreased LOC CV- hypotension Respiratory- hypoxemia Renal- low UO Hematological- Thrombocytopenia Metabolic- Elevated lactate Septic Shock: Hypotension that persists despite adequate fluid resuscitation

14 2016 Sepsis-3! Now What!

15 Sepsis 3: 2016 Sepsis is: life-threatening organ dysfunction caused by a disregulated host response to infection Sepsis-3 does away with: SIRS criteria (sepsis is pro- and anti-inflammatory) Severe sepsis (sepsis = the old severe sepsis) Antiquated concepts: sepsis syndrome; septicemia Singer et al, JAMA PMID:

16 Sepsis 3 Sepsis-3 organizes the measurement of organ dysfunction through the SOFA score (Sequential Organ Failure Assessment) Septic shock: vasopressor-dependent hypotension + lactate >2 Sepsis-3 includes clinical criteria to predict lifethreatening disease 16

17 New Diagnostic Triggers quicksofa, or qsofa (Sequential (sepsis induced) Organ Failure Assessment) The qsofa assessment directs physicians to look for these warning signs in patients: An alteration in mental status A decrease in systolic blood pressure of less than 100 mm Hg A respiration rate greater than 22 breaths/min

18 Can qsofa Help? Score of 2 or greater is predictive for poor outcome and increased length of stay Decreased blood pressure <110mmHg (SBP) Increased respiratory rate > 22/min Change in LOC GCS <15 Level of care determinant: They might not have sepsis but are sick and likely will need an ICU bed! Inpatient screening 18

19 What Does it Mean for You? Early treatment of sepsis remains critical to improving outcomes Early treatment requires early identification Most sepsis patients are presenting through the ED Continue to use the processes currently in place early identification and treatment in the ED hospital wards Consider... Do SEPSIS-3 definitions fundamentally alter these processes? What are the competing priorities in improving sepsis care that can help put SEPSIS-3 into context with our current strategies? 19

20 Sepsis Today Science Sepsis 3 & qsofa Regulatory SEP-1 Severe Sepsis & SIRS Performance Improvement Improve Identification & Treatment 20 Despite Challenges- Treatment Unchanged

21 Early Detection! Screen every EMS Patient in the Field Screen Every Emergency Patient Screen All Seriously Ill Adult Inpatients Prioritize infections most frequently associated with sepsis UTI, Pneumonia, Abdominal Use the EMR for prompts, and alerts Treat all Elderly Patients as High Risk May have atypical signs- Altered MS, Afebrile

22

23 Sepsis Diagnosis Is Difficult No single criteria makes the diagnosis (Unlike New ST Elevation on ECG, or New Onset Focal Neuro Exam) Patient status changes during encounter Diagnosis not black and white but gray Patient may look good and yet crash two hours later Many physicians like an observation period before reacting, and they lose the critical window of opportunity HUMAN FACTORS Competing priorities, lack of awareness, patient looking good leads physicians to going down another path.

24 Leverage Technology for Inpatients Use EMR for inpatient screening Best Practice Alerts MEWs, early warning score to detect at risk patients for decline will capture more than just sepsis Prompts for Interventions Contact MD or RRT Request lactate because one has not been drawn in 4 hours Request blood culture because they have not been drawn N/A pt. does not have suspected or known infection

25 Use Best Practice Alerts

26 Tips for Inpatient Sepsis Detection Screen for sepsis every shift and at transfers Use the EMR Develop Alerts Optimize Rapid Response Team involvement 26

27 But Don t These Cry Wolf? Yes There are no alerts that have optimal sensitivity and specificity But often there is a 27

28 Sensitivity? Specificity? Is that BioStats? SENSITIVITY: The ability of a test to correctly identify a condition when it IS PRESENT SPECIFICITY: The ability of a test to correctly identify that a condition is NOT PRESENT when it is not! Presentation Title Footer 28

29 Yesterday s Annals of Internal Medicine SIRS: more sensitive qsofa: more specific Presentation Title Footer 29

30 Polling Question What s Happening at Your Hospital? Where are you screening for sepsis? In the ED In the inpatient units EMS

31 Create Action: Bundle implementation Identify clear and concise action for positive sepsis screen Who does what? By when? Build in concurrent review

32 Time Sensitive Diagnoses: Changing the Paradigm of Practice AMI Stroke Trauma

33 Make Early Easy Automatic Order sets Protocols for fluid, antibiotics and labs Bundle blood cultures with lactate

34 Protocols Compliance vs Adherence

35 Mobilize resources What are they? Mobilize experts Who are they? Consensus in diagnosis Allow for clinical decisions Time sensitive Create action Antibiotics Labs Fluids RRT Can they be involved?

36 Major Surprises in Sepsis Management Highest Mortality Sepsis diagnosed on the floors Lactate >2 mmol/l but < 4 mmol/l Bundle Compliance Worst on the floor Hospitals with RRT/Sepsis Alert as resource saves most lives

37 Positive Sepsis Screen: 3hr Bundle (to be completed within 3 hours of presentation) Measure lactate level Obtain blood cultures prior to administration of antibiotics Administer broad spectrum antibiotics Administer 30ml/kg crystalloid for hypotension or lactate 4mmol/L

38 Polling Question Antibiotics are given within three hours of a positive sepsis screen Antibiotics are given within two hours of a positive sepsis screen Antibiotics are given within one hours of a positive sepsis screen

39 Just in- Time Does Matter Patients who received antibiotics (late) after 3-hours mortality increased by 14% Each hour of time to the completion of the 3- hour bundle was associated with higher mortality (3 percentage points higher) No association between the time to completion of the initial bolus of intravenous fluids. NOT to be interpreted as evidence in favor of abandoning early fluid resuscitation. 39

40 30ml/kg crystalloid for hypotension or lactate 4mmol/L

41 Whoa Wait a Minute... That s a lot of fluid for some folks physicians or patients! Common point of physician resistance 41

42 What To Do? Coaching and Literature Liu et al (attached) These patients are here for sepsis, not for their underlying co-morbidity Patients who best were CHF and RF patients who got fluids per recommendations Small tests of change Give ½ then immediately use an accepted method for determining fluid status Continue to assess until fluid status is optimal But which method is best? 42

43 Why Do All Severe Sepsis Patients Need Volume?? 1. Vascular volume is lost into interstitial space do to diffuse capillary leaking from cytokine release 2. Both venous and arteriolar tone is reduced & blood volume occupies a larger intravascular space than normal 3. Many patients also have GI and Skin losses

44 Does Early Aggressive Therapy Make a Difference?

45 One liter of normal saline adds 275 ml to the patient s plasma volume FACT:

46 Chat in Do you have challenges with fluid administration? If so, what are they?

47 6 Hour Bundle Persistent Hypotension or Lactate >4mmol/L Apply vasopressors For hypotension that does not respond to initial fluid resuscitation - to maintain a mean arterial pressure (MAP) 65mmHg - Norepinephrine Re-assess volume status and tissue perfusion and document findings In the event of persistent hypotension after initial fluid administration (MAP < 65 mm Hg) or if initial lactate was 4 mmol/l Re-measure lactate if initial lactate elevated Guiding resuscitation to normalize lactate in patients with elevated lactate levels as a marker of tissue hypoperfusion 47

48 Updates For 6 Hour Bundle Requiring measurement of CVP and ScvO2 in all patients with lactate >4 mmol/l and/or persistent hypotension after initial fluid challenge and timely antibiotics is NOT supported by available evidence Dynamic measures vs. static measures are now recommended to predict fluid responsiveness where available Frequent assessment of the patients volume status is crucial throughout the resuscitation period Therefore

49 Re-assess Volume Status and Tissue Perfusion and Document Findings By. EITHER: Repeat focused exam (after initial fluid resuscitation) a by licensed independent practitioner including vital signs, cardiopulmonary, capillary refill, pulse and skin findings OR TWO OF THE FOLLOWING: Measure CVP -static Measure ScVO2 -static Bedside cardiovascular ultrasound-dynamic IVC Dynamic assessment of fluid responsiveness with passive leg raise or fluid challenge -dynamic 49

50 So.Putting It All Together Stay the course..for now. Screen every patient in triage or evaluation. Screen inpatients every shift. Bundle blood cultures with lactate. Administer antibiotics within an hour. Clear and consistent actions after a positive sepsis screen. Use Alerts & EMR Enhance communication between levels of care. Outcomes will follow.

51

52 Resources Surviving Sepsis Campaign ProCESS Investigators, Yealy DM, Kellum JA, Juang DT, et al. A randomized trial of protocol-based care for early septic shock. N Engl J Med 2014; 370(18): The ARISE Investigators and the ANZICS Clinical Trials Group. Goal-directed resuscitation for patients with early septic shock. N Engl J Med 2014; 371: Mouncey PR, Osborn TM, Power GS, et al for the ProMISe trial investigators. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med 2015: DOI: /NEJMoa Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001;345: Liu VX, Morehouse JW, Marelich GP, Soule J, Russell T, Skeath M, Adams C, Escobar GJ, Whippy A. Multicenter Implementation of a Treatment Bundle for Sepsis Patients with Intermediate Lactate Values. Am J Respir Crit Care Med 2015.

53 Resources Ouellette, D. R., & Shah, S. Z. (2014). Comparison of outcomes from sepsis between patients with and without pre-existing left ventricular dysfunction: a case-control analysis. Critical Care, 18(2), R Singer M, Deutschman CS, Seymour CW, et al: The Sepsis Definitions Task Force The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). (JAMA, February 23, 2016, Vol 315, No. 8). Shankar-Hari M, Phillips G, Levy ML, et al. Assessment of definition and clinical criteria for septic shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). (JAMA, February 23, 2016, Vol 315, No. 8). Seymour CW, Liu V, Iwashyna TJ, et al. Assessment of clinical criteria for sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). (JAMA, February 23, 2016, Vol 315, No. 8).

54 KEY ARTICLE APPENDIX FOLLOWS

55 Trauma Patients From Am. College of Surgeons ATLS Manuel

56 Fluids Prevent Intubation From Rivers: % Ventilated patients Hours after start of Therapy Standard Therapy 53.8% 16.8% 70.6% Early Goal Directed Therapy 53% 2.6% 55.6% P Value < Chronic coexisting conditions--chf: 30.2% EGDT 36.7% Control N Engl J Med 2001;345:

57

58

59 The PRISM Investigators. Early, Goal-Directed Therapy for Septic Shock A Patient-Level Meta-Analysis. N Engl J Med 2017; 376: Subgroup analyses showed no benefit from EGDT for patients with worse shock (higher lactate, hypotension, predicted risk of death). EGDT did not result in better outcomes than usual care and was associated with higher hospitalization costs across a broad range of patient and hospital characteristics.

60 Differences between treatment and control groups in the ProCESS, ARISE, and ProMISE Trials: Clinical Trial Cohort Intravenous Fluids (milliliters) Central Line Placement Vasopressor Utilization ProCESS May 2014 EGDT / /439 (93.6%) 241/439 (54.9%) Usual Care / /456 (57.9%) 201/456 (44.1%) Δ 526ml 35.7% 10.8% ARISE October 2014 EGDT 1964+/ /793 (90%) 528/793 (66.6%) Usual Care 1713+/ /798 (61.9%) 461/798 (57.8%) Δ 251ml 28.1% 8.8% ProMISE May 2015 EGDT 2000 ( ) 575/624 (92%) 332/623 (53.3%) Usual Care 1784 ( ) 318/625 (50.9%) 291/625 (46.6%) Δ 216ml 41.1% 6.7% ProCESS Investigators, Yealy DM, Kellum JA, Juang DT, et al. A randomized trial of protocol-based care for early septic shock. N Engl J Med 2014; 370(18): The ARISE Investigators and the ANZICS Clinical Trials Group. Goal-directed resuscitation for patients with early septic shock. N Engl J Med 2014; 371: Mouncey PR, Osborn TM, Power GS, et al for the ProMISe trial investigators. Trial of early, goal-directed resuscitation for septic shock. N Engl 60 J Med 2015: DOI: /NEJMoa

61 MD Ability to Predict Hemodynamics Survey administered pre-pa catheterization Variable N measured % correct prediction of range of actual value Wedge Pressure % Cardiac Output 97 51% SVR 88 44% R Atrial Pressure 98 55% CCM 1984 Vol 12, No. 7 pp

62 Can We Predict Mortality in Infected Patients? Systolic BP 90 still have lactate and mortality Lowest ED reading ICM 2007 Vol 33:

63 Lathan HE, Bengston CD, Satterwhite, L et al. Stroke volume guided resuscitation in severe sepsis and septic shock improves outcomes. Journal of Critical Care 42 (2017)

64 Lathan HE, Bengston CD, Satterwhite, L et al. Stroke volume guided resuscitation in severe sepsis and septic shock improves outcomes. Journal of Critical Care 42 (2017)

65 Seymour CW, Gesten F, Prescott H et al. Time to Treatment and Mortality during Mandated Emergency Care for Sepsis. N Engl J Med 2017; 376:

66 Seymour CW, Gesten F, Prescott H et al. Time to Treatment and Mortality during Mandated Emergency Care for Sepsis. N Engl J Med 2017; 376:

67 Liu VX, Morehouse J, Marelich G et al. Multicenter Implementation of a Treatment Bundle for Patients with Sepsis and Intermediate Lactate Values. Am J Respir Crit Care Med Vol 193, Iss 11, pp

68 Liu VX, Morehouse J, Marelich G et al. Multicenter Implementation of a Treatment Bundle for Patients with Sepsis and Intermediate Lactate Values. Am J Respir Crit Care Med Vol 193, Iss 11, pp

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