Steps to Success in SepsisASHNHA Quality Webinar

Maryanne Whitney, RN, CNS, MSNImprovement Advisor, Cynosure Health

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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

Sepsis Remains a Killer in our Midst

http://www.youtube.com/watch?v=jsXYBufeiBs

Severe Sepsis: A Significant Healthcare Challenge

• Hospitalizations have doubled 2000-2008• Most costly reason for hospitalization in 2011

– 20 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

The # 1 Cause of Inpatient Death

The same pattern in every hospital

Anchorage Hospitals – Sepsis Mortality Rates

Alaska Sepsis Mortality Reduction, 2014-2017

Severe Sepsis vs Other Disease Priorities

Care Priorities U.S. Incidence # of Deaths Mortality Rate

AMI 900,000 225,000 25%Stroke 700,000 163,500 23%Trauma

(Motor Vehicle)2.9 million

(injuries)42,643 1.5%

Severe Sepsis 751,000 215,000 29%

Critical ActionsThe Keys to achieving a reduction in mortality

from severe sepsis are Early Recognition & Evidence Based Treatment. BOTH MUST occur.

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

Definitions Drive Treatment

Infection or

trauma

SIRSSystemic

Inflammatory Response Syndrome

Sepsis2 or more

SIRS + Infection

Severe Sepsis

Sepsis + s/s of organ

dysfunction

Septic Shock

Refractory Hypotension +/or lactate

>= 4

Sepsis is a Continuum

Standard Definitions• Severe Sepsis: Sepsis-

induced tissue hypo-perfusion 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

• 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

2016 “Sepsis-3”! Now What!

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

15Singer et al, JAMA 2016. PMID: 26903338

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 life-threatening disease

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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

http://qsofa.org/

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

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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?

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Sepsis Today

ImproveIdentification & Treatment

ScienceSepsis 3 &

qSOFA

RegulatorySEP-1

Severe Sepsis & SIRS

Performance Improvement

20Despite Challenges- Treatment Unchanged

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

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.

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

Use Best Practice Alerts

Tips for Inpatient Sepsis Detection

• Screen for sepsis every shift and at transfers

• Use the EMR• Develop Alerts• Optimize Rapid

Response Team involvement

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But Don’t These Cry “Wolf”?

• Yes• There are no alerts that have optimal

sensitivity and specificity

• But often there is a…

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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 Footer28

Yesterday’s Annals of Internal Medicine

Presentation Title Footer29

• SIRS: more sensitive• qSOFA: more specific

http://annals.org/aim/article-abstract/2671919/prognostic-accuracy-quick-sequential-organ-failure-assessment-mortality-patients-suspected

Polling QuestionWhat’s Happening at Your Hospital?• Where are you screening for sepsis?

– In the ED– In the inpatient units– EMS

Create Action: Bundle implementation

Identify clear and concise action for positive sepsis screen Who does what? By when? Build in concurrent review

Time Sensitive Diagnoses:Changing the Paradigm of Practice

TraumaStroke AMI

Make Early Easy

• Automatic– Order sets– Protocols for fluid, antibiotics and labs– Bundle blood cultures with lactate

ProtocolsCompliance vs Adherence

• 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?

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

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

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

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.

39http://www.nejm.org/doi/full/10.1056/NEJMoa1703058#t=article

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

Whoa…Wait a Minute....• That’s a lot of fluid for some folks

– physicians or patients!

• Common point of physician resistance

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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?

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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

Does Early Aggressive Therapy Make a

Difference?

FACT:

• One liter of normal saline adds 275 ml to the patient’s plasma volume

Chat in• Do you have challenges with fluid

administration? If so, what are they?

6 Hour BundlePersistent 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

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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

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

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So….Putting It All TogetherStay the course…..for now.

Screen every patient in ED @ 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.

mwhitney@cynosurehealth.org

Resources• Surviving Sepsis Campaign http://www.survivingsepsis.org• 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):1683-1693. • The ARISE Investigators and the ANZICS Clinical Trials Group. Goal-directed resuscitation

for patients with early septic shock. N Engl J Med 2014; 371:1496-1506. • 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: 10.1056/NEJMoa1500896.

• 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;345:1368-137

• http://www.sccm.org/Research/Quality/Pages/Sepsis-Definitions.aspx• 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.

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), R79. http://doi.org/10.1186/cc13840

• http://qsofa.org/• 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).

KEY ARTICLE APPENDIX FOLLOWS

From Am. College of Surgeons ATLS Manuel

Trauma Patients

Fluids Prevent Intubation

• From Rivers: % Ventilated patients

Hours after start of Therapy0-6 7-72 0-72

Standard Therapy 53.8% 16.8% 70.6%Early Goal Directed Therapy

53% 2.6% 55.6%P Value <.001 0.02

N Engl J Med 2001;345:1368-1377

Chronic coexisting conditions--CHF: Control 30.2%

EGDT 36.7%

The PRISM Investigators. Early, Goal-Directed Therapy for Septic Shock— A Patient-Level Meta-Analysis.

N Engl J Med 2017; 376:2223-2234.

• 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.

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Clinical Trial Cohort Intravenous Fluids

(milliliters)

Central Line Placement

Vasopressor Utilization

ProCESS

May 2014

EGDT 2805 +/- 1957 411/439 (93.6%) 241/439 (54.9%)

Usual Care 2279 +/- 1881 264/456 (57.9%) 201/456 (44.1%)

Δ 526ml 35.7% 10.8%

ARISE

October 2014

EGDT 1964+/-1415 714/793 (90%) 528/793 (66.6%)

Usual Care 1713+/-1401 494/798 (61.9%) 461/798 (57.8%)

Δ 251ml 28.1% 8.8%

ProMISE

May 2015

EGDT 2000 (1150-3000) 575/624 (92%) 332/623 (53.3%)

Usual Care 1784 (1075-2775) 318/625 (50.9%) 291/625 (46.6%)

Δ 216ml 41.1% 6.7%

Differences between treatment and control groupsin the ProCESS, ARISE, and ProMISE Trials:

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):1683-1693.The ARISE Investigators and the ANZICS Clinical Trials Group. Goal-directed resuscitation for patients with early septic shock. N Engl J Med 2014; 371:1496-1506. Mouncey PR, Osborn TM, Power GS, et al for the ProMISe trial investigators. Trial of early, goal-directed resuscitation for septic shock. N EnglJ Med 2015: DOI: 10.1056/NEJMoa1500896.

MD Ability to Predict Hemodynamics

Survey administered pre-PA catheterization

Variable N measured % correct prediction of range of actual value

Wedge Pressure 102 30%Cardiac Output 97 51%SVR 88 44%R Atrial Pressure 98 55%

CCM 1984 Vol 12, No. 7 pp549-553

Can We Predict Mortality in Infected Patients?

Systolic BP ≥ 90 still have ↑ lactate and mortality

ICM 2007 Vol 33: 1892-1899

Lowest ED reading

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) 42-46.

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) 42-46.

Seymour CW, Gesten F, Prescott H et al. Time to Treatment and Mortality during Mandated Emergency Care for Sepsis.

N Engl J Med 2017; 376:2235-2244. .

Seymour CW, Gesten F, Prescott H et al. Time to Treatment and Mortality during Mandated Emergency Care for Sepsis.

N Engl J Med 2017; 376:2235-2244. .

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 1264–1270.

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 1264–1270.