Overview - Kathleen Vollman [Compatibility Mode].pdf · diit d(1C) standardized ICU policy. (Given to patients who respond poorly to fluids or vasopressors) (2C) Drotrecogin alfa

1

Surviving Sepsis Surviving Sepsis Campaign: Impacting Campaign: Impacting Patient Outcomes Patient Outcomes

Surviving Sepsis Surviving Sepsis Campaign: Impacting Campaign: Impacting Patient Outcomes Patient Outcomes mmThrough Early Through Early Recognition & Recognition & Management of Management of S iS i

mmThrough Early Through Early Recognition & Recognition & Management of Management of S iS iSepsisSepsisSepsisSepsis Kathleen M. Vollman RN, MSN, CCNS, FCCM, FAAN

Clinical Nurse Specialist/Educator/ConsultantSepsis Solutions International LLC

[email protected], Michiganwww.vollman.com

© Sepsis Solutions International 2010

Overview

• Significance of the Problem• Defining the continuum• Defining the continuum• Brief overview of Pathophysiologic derangements• Prevention• Early Recognition & Resuscitation• Case Studies

O t t di• Outcome studies

2

Severe Sepsis: A Significant Healthcare Challenge• Major cause of morbidity and mortality

worldwideworldwide– Leading cause of death in noncoronary ICU (US)1

– 10th leading cause of death overall (US)2*

• More than 750,000 cases of severe sepsis in the US annually3

I th US more than 500 patientsmore than 500 patients

* Based on data for septicemia †Reflects hospital-wide cases of severe sepsis as defined by infection in the presence of organ dysfunction

1 Sands KE, et al. JAMA 1997;278:234-40.2 National Vital Statistics Reports. 2005.3 Angus DC, et al. Crit Care Med 2001;29:1303-10.

• In the US, more than 500 patients more than 500 patients die of severe sepsis dailydie of severe sepsis daily

Severe Sepsis: Comparison with Other Diseases

350

IncidenceCases per 100,000

250,000

MortalityDeaths per year

0

50

100

150

200

250

300

0

50,000

100,000

150,000

200,000

Mortality from severe sepsis remains unacceptably high,even with the best standard care4

AIDS1 Coloncancer2

Breastcancer2

CHF3 Severe sepsis4

AIDS1 Breastcancer2

AMI3 Severe sepsis4

Data from: 1. National Center for Health Statistics, 2001. 2. American Cancer Society, 2001. 3. American Heart Association, 2000. 4. Angus DC, et al. Crit Care Med. 2001;29:1303-1310.

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How Does Severe Sepsis Compare to Your Current Care Priorities?

Quality P j t

US I id

# of Deaths Mortality R tProjects Incidence Rate

AMI1 895,000 171,000 19%

Stroke1 700,000 157,800 23%

Pneumonia2 1,300,000 61,800 4.8%

Severe Sepsis3 751,000 215,000 29%

Why do you think that severe sepsis has not received the same focus as these other common disease states?

1. American Heart Association. Heart Disease and Stroke Statistics 2006 Update. 2. National Center for Health Statistics. Available at: www.cdc.gov/nchs/fastats/pneumonia.htm. Accessed February 4, 2005. 3. Angus DC, et al. Crit Care Med 2001;29(7):1303-1310.

The Severe Sepsis Bundles: Surviving Sepsis Campaign/IHI

Management Bundle(To be accomplished as soon as possible d over first 24 hours):

Low-dose steroids administered for septic shock in accordance with a

Resuscitation Bundle(To be accomplished as soon as possible over first 6 hours):

Serum lactate measured.

Blood cultures obtained prior to antibiotics d i i t d (1C) standardized ICU policy. (Given to

patients who respond poorly to fluids or vasopressors) (2C)

Drotrecogin alfa (activated) administered in accordance with a standardized ICU policy. (Given to patients with sepsis induced organ dysfunction at high risk of death (2B)

Glucose control maintained to < 150 mg/dL (8.3 mmol/L). (2C)

Tidal volume 6 ml/kg (1B) Inspiratory

administered. (1C)

Perform imaging studies promptly to fine source (1C)

From the time of presentation, broad- spectrum antibiotics within 3 hours for ED admissions and 1 hour for non-ED ICU admissions. (1D/1B)

For hypotension and/or lactate > 4 mmol/L:

Deliver an initial minimum of 20 mL/kg of crystalloid (or colloid equivalent) (1C)

Apply vasopressors for hypotension not responding to initial fluid resuscitation to g ( ) p y

plateau pressures < 30 cmH2O for mechanically ventilated patients. (1C)

p gmaintain MAP > 65 mmHg.

For persistent hypotension despite initial fluid resuscitation (septic shock) and/or lactate > 4 mmol/L: 1C

Achieve CVP > 8 mmHg & MAP > 65 mmHg & UO >0.5mL/kg/hr

Achieve ScvO2 of > 70% or SvO2 > 65%.

if ScvO2 not > 70% blood or dobutamine (2C)Adapted from the revised guidelines: CCM 2008;36:296-327.

4

Why Prevention?

• 2.5 million HAI’s year/USA

E d 247 l di i h USA• Everyday, 247 people die in the USA as a result of a HAI

• 5-10% of all patients admitted to US hospital annually contract HAI’s (1 of every 10-20 patients)

• 6th leading cause of death in the US• 6 leading cause of death in the US

• Higher nurse staffing results in lower HAI’s*

*Hugonnet S et al CCM 2007;35:76-81*Pronovost PJ et al JAMA 1999;281:1310-1317*Needleman J et al. N Engl of Med 2002;346:1715-1722

WHO 2005Yokoe DS, et al. Infect Control Hosp Epidemiol 2008;29:S12-S21.

Notes on Hospitals: 1859

“It may seem a strangeIt may seem a strange principle to enunciate as the very first requirement in a Hospital that it should do the sick no harm.”sick no harm.

-Florence Nightingale

5

Fortifying Host Defense

Implement Interventional Patient Hygiene

Interventional Patient Hygiene

Hygiene…the science and practice f th t bli h t dof the establishment and

maintenance of health

Interventional Patient Hygiene….nursing action plan directly focused on fortifying the patients host defense throughpatients host defense through proactive use of evidence based hygiene care strategiesIncontinence Associated Dermatitis Prevention

Program

6

INTERVENTIONAL PATIENT HYGIENE(IPH)

Oral Care/ Mobility

VAP/HAP

ob ty

HAND

HYGIENE

Patient

Catheter Care

CA-UTI CA-BSI

Skin Care/ Bathing/Mobility

HASISSIVollman KM. Australian Crit Care, 2009;22(4): 152-154

Measuring

4-Tier Process for Severe Sepsis Program Implementation

Early Screening with

Implementation of the Sepsis Bundle

Success

Organizational Consensus that Severe SepsisMust be Managed Early and Aggressively

Early Screening with Tools and Triggers

7

Tier I: Organization Support

– Executive management at hospital actively supports the Severe Sepsis ProgramI i f i i li d ith– Improving care of severe sepsis is aligned with hospital’s current year goals

– Willingness to align resources with program: • Sepsis champion has guarded time of 10-20 hrs

per week to oversee program and ensure data collection is ongoing

• Need resource to support data collection– Established team in place with ICU physician and

nurse champion, ED physician and nurse champion that are recognized leaders in the hospital

– Collect baseline process and outcome data– Create team charter

2nd-Tier : Implementation of Early Screening Tools and Triggers

Screens and triggers developedto ID Severe Sepsis


to ID Severe Sepsis patients in the ED, ICU, and

on patient care units

8

Severe Sepsis: Defining a Disease Continuum

SepsisSIRSInfection Severe Sepsis

SIRS with a

presumed or confirmed

Sepsiswith 1 sign of organ

dysfunction, hypoperfusion or

hypotension.

Examples:• Cardiovascular

Adult CriteriaA clinical response arising from a nonspecific insult, including ≥ 2

of the following:

Temperature:> 38°C or < 36°Cconfirmed infectious process

(refractory hypotension)• Renal• Respiratory• Hepatic• Hematologic• CNS• Unexplained metabolic acidosis

Heart Rate: > 90 beats/minRespiration:> 20/minWBC count: > 12,000/mm3,

or < 4,000/mm3,or > 10% immature neutrophils

SIRS = Systemic Inflammatory Response SyndromeBone et al. Chest.1992;101:1644-1654.

Shock

Signs & Symptoms of Sepsis

Pl t l t Platelets Bands Skin perfusion Urine outputSkin mottlingPoor capillary refill

31

ChillsAlteration in LOCTachypneaUnexplained metabolicacidosisHeart rate

HyperglycemiaPurpura/petechia

Altered blood pressure

Levy M, et al. Crit Care Med 2003;31:1250-6.

9


SepsisSIRSInfection orTrauma

Severe Sepsis

SIRSwith a

presumed or confirmedconfirmed infectious process



SepsisSIRSInfection orTrauma

Severe Sepsis

.

Examples:

• Cardiovascular (refractory hypotension)

Sepsiswith 1 sign of organ

dysfunction, hypoperfusion or hypotension

• Renal• Respiratory• Hepatic• Hematologic• CNS• Unexplained metabolic acidosis


Shock

10

Identifying Acute Organ Dysfunction as a Marker of Severe Sepsis

TachycardiaSBP<90mmHgIncreasing O2

i

RespiratoryRespiratoryCardiovascularCardiovascular

MAP < 70mmHg (despite fluid)Need for Vasopressors

requirementsPaO2/FiO2 250 with other organ dysfunction/lung not site of infection

UO <0.5 ml/kg per hr(despite fluid)

RenalRenal

NeurologicNeurologic

Change in LOC

Unexplained metabolic acidosis•Lactate > 1.5 times upper normal

Platelets <80,000/mm3

Decline in platelet count of 50% over 3 days

MetabolicMetabolicHematologicHematologic

Change in LOC

Deterioration of Cardiovascular Function on Day 1 was Associated with Increased Mortality in Placebo Patients

Change in Vasopressor Dose on Day 1*†

58%y P<0.0070

54%58%

37%

20%

% M

orta

lity 01

40

50

60

20

30

20

* 28-day mortality for standard therapy patients enrolled in PROWESS and a Phase II study of an investigational anti-sepsis drug.† Vasopressor requirement at study entry through day 1. Based on the Sequential Organ Failure Assessment (SOFA) score, low dose was

defined as dopamine 6-15 µg/kg/min, epinephrine 0.1 µg/kg/min, or norepinephrine 0.1 µg/kg/min. High dose was defined as dopamine > 15 µg/kg/min, epinephrine > 0.1 µg/kg/min, or norepinephrine >0.1 µg/kg/min.

Levy, M., Macias, W., Vincent, J., et al. Early changes in organ function predict eventual survival in severe sepsis. Crit Care Med. 2005; 33:1-8.

No Vasopressor No Vasopressor to Low Dose

No Vasopressor to High Dose

CV SOFA Increased by 1

n=294 n=41 n=36 n=46

0

11

Renal Dysfunction (Mortality by Change in Serum Creatinine) in Placebo Patients

Severe sepsis mortality predictors (Baseline to Day 1)Population-based outcomes observed in severe sepsis patientsIn PROWESS, patients with chronic kidney failure on dialysis were excluded. The following was observed in patients with acute kidney dysfunction at baseline (renal SOFA = 2)†‡

20

30

40

50

60

70CMH Trend TestP<0.0001

19%

35%

61%

21

† Renal SOFA Score = 2 equivalent to creatinine range 2.0 - 3.4 mg/dL.‡ APACHE (Acute Physiology And Chronic Health Evaluation). For more information

on using the APACHE II scoring system, please see http://www.sfar.org/scores2/scores2.html.

Levy, M., Macias, W., Vincent, J., et al. Early changes in organ function predict eventual survival in severe sepsis. Crit Care Med. 2005; 33:1-8.Data on file, Eli Lilly and Company: XIG20060922a.

0

10

1.2 TO 1.9 mg/dLTO

< 1.2 mg/dL

1.2 TO 1.9 mg/dLTO

1.2 TO 1.9 mg/dL

1.2 TO 1.9 mg/dLTO

> 1.9 mg/dL

N=129 N=109 N=38

12

Homeostasis Is Unbalanced in Severe Sepsis

FIBRINOLYSISFIBRINOLYSISCOAGULATIONCOAGULATIONINFLAMMATIONINFLAMMATION

Homeostasis

Carvalho AC, Freeman NJ. J Crit Illness 1994;9:51-75.Kidokoro A, et al. Shock 1996;5:223-8.Vervloet MG, et al. Semin Thromb Hemost 1998;24:33-44.

Inflammation, Coagulation and Impaired Fibrinolysis In Severe Sepsis

Endothelium COAGULATION CASCADE

Monocyte

IL-6IL-1TNF-

TAFI

PAI-1

Suppressedfibrinolysis

Factor VIIIaTissue Factor

Factor Va

THROMBIN

Reprinted with permission from the National Initiative in Sepsis Education (NISE).

Neutrophil

IL-6

Inflammatory Responseto Infection

Thrombotic Responseto Infection

Fibrinolytic Responseto Infection

Fibrin

Fibrin clotTissue Factor

13

The Role Of Endogenous Activated Protein C In Severe Sepsis

Endothelium Activated Protein CCOAGULATION CASCADE

Monocyte

IL-6

Inactivation

Inactivation

Inactivation

Activated Protein CPAI-1

SuppressedfibrinolysisActivated

Protein CInhi

bitio

nFactor VIIIa

Tissue Factor

Factor Va

THROMBIN

Organisms

Adapted from Bernard GR, et al. N Engl J Med. 2001;344:699-709

Neutrophil

IL-6

Inhi

bitio

n

Activated Protein C

Fibrin

Fibrin clotTissue Factor

Inflammatory Responseto Infection

Thrombotic Responseto Infection

Fibrinolytic Responseto Infection

MICROCIRCULATION: SUBLINGUAL BLOOD FLOW

Healthy Volunteer• BP: 120/80 mm Hg

• SaO2: 98%

Septic Shock Patient

Resuscitated with fluids

1. www.opsimaging.net. Accessed April 2004. 2. Spronk PE, et al. Lancet. 2002;360:1395-1396.

Resuscitated with fluids and dopamine– HR: 82 BPM

– BP: 90/35 mmHg

– SaO2: 98%

– CVP: 25 mmHg

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OXYGEN SUPPLY/DEMAND OXYGEN SUPPLY/DEMAND DYNAMICSDYNAMICS

ScvO2CVP, CO, CI,

SV, SVI

Cornerstones of Multidisciplinary Management of Severe Sepsis/MODS

P tiP ti•• PreventionPrevention

•• Screening and Early IdentificationScreening and Early Identification

•• Early Intervention: Source control, Blood cultures Early Intervention: Source control, Blood cultures and broad spectrum antibioticsand broad spectrum antibiotics

•• Resuscitation BundleResuscitation Bundle

•• Management BundleManagement Bundle

15

2nd-Tier : Implementation of Early Screening Tools and Triggers

Screens and triggers developedto ID Severe Sepsis


to ID Severe Sepsis patients in the ED, ICU, and

on patient care units

EARLY MANAGEMENT

Early Recognition Early Recognition & Source Control& Source Control

ICU/Additional ICU/Additional E l A tibi tiE l A tibi ti

Prompt/Aggressive Prompt/Aggressive ResuscitationResuscitation

EvidenceEvidence

Based TherapiesBased Therapies

Early AntibioticsEarly Antibiotics

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Early Recognition: A Screening Process

• TIME IS TISSUE!! – If you identify patients early then you can

intervene and prevent further tissue damage

• To screen effectively, it must be part of the nurses’ daily routine

• Must define a process for what to do with the results of the screen

If you don’t screen you will miss patients that could have benefited from the interventions

Make it Process Dependent

• Weave into fabric of currentWeave into fabric of current practice

• Assess for daily

• Identify strategies for initiation of therapy response once patient is identified

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Incorporate Screening and Early Identification Throughout the Hospital

• Emergency Departmentg y p

• ICUs

• Patient Care Units

• Rapid Response Team

18

ER Screen

Screening: Barriers/Strategies

• Barriers– Time for nurses to do it (perception vs. reality)

– Screening is not sensitive only for severe sepsis

– Positive screen is not a diagnosis of severe sepsis

• Strategies– Must assign responsibility and enforce accountability

P f di li– Perform audits to measure compliance and identify problems

– Round on unit and ask nurses how it is going and discuss issues

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Screening

•• Lesson Learned: Bedside nurse must do Lesson Learned: Bedside nurse must do screeningscreeningscreeningscreening

•• Education/Simulation/EducationEducation/Simulation/Education-- Every 6 monthsEvery 6 months

-- Build into orientationBuild into orientation

-- Must be part of their documentation structureMust be part of their documentation structure

-- PracticePractice--PracticePractice--PracticePracticePracticePractice PracticePractice PracticePractice

The END RESULT—anytime patient has 2 or more SIRS—will think that this patient might have sepsis and can screen at that time

Clinical Scenario II: Early identification and intervention

• 88 year old 51 6kg white female admit from• 88 year old, 51.6kg,white, female admit from ED; resided in ECF

• History: CAD, COPD, dementia, Alzheimer disease, depression, SVT

• Chief Complaint: rib pain, chest congestion and SOBand SOB

• Awake, alert and oriented, slight combative (history of combative behavior)

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Clinical Scenario II: Early Identification and Intervention

• Initial VS:– Temp: 101.6 Fp– RR: 31– HR: 109, atrial fib with occasional SVT– B/P: 79/51– 2L of O2, O2 sat of 96%

• Does this patient screen positive for severe sepsis?

21

Chain of Command

• When to use it?

• Who is it?

• How to implement the chain of command?

EARLY MANAGEMENT

Early Recognition & Early Recognition & Source ControlSource Control

ICU/Additional ICU/Additional

Early AntibioticsEarly Antibiotics

Prompt/Aggressive Prompt/Aggressive EvidenceEvidence

Based TherapiesBased Therapies

p ggp ggResuscitationResuscitation

22


Management Bundle(To be accomplished as soon as possible over first 24 hours):

Low-dose steroids administered for septic shock in accordance with a

Resuscitation Bundle(To be accomplished as soon as possible over first 6 hours):


Blood cultures obtained prior to antibiotics d i i t d (1C) standardized ICU policy. (Given to

patients who respond poorly to fluids or vasopressors) (2C)



Tidal volume 6 ml/kg (1B) Inspiratory

administered. (1C)





Apply vasopressors for hypotension not responding to initial fluid resuscitation to g ( ) p y

plateau pressures < 30 cmH2O for mechanically ventilated patients. (1C)





if ScvO2 not > 70% blood or dobutamine (2C)Adapted from the revised guidelines: CCM 2008;36:296-327.

23

Serum Lactate is associated with mortality in severe sepsis independent of organ failure and shock

Objective:

– Test whether the association between initial serum lactate level and mortality in patients presenting tolactate level and mortality in patients presenting to the ED with severe sepsis is independent of organ dysfunction and shock

Design:

– Retrospective, single center cohort study

– Academic teaching hospital

Patients:

– 830 adults admitted with severe sepsis in the ED

– Stratified lactate into 3 groups: low (<2), intermediate (2-3.9) and high (> or equal to 4)

Mikkelsen, Mark et al CCM 2009 Vol 37 No 5

Serum Lactate is associated with mortality in severe sepsis independent of organ failure and shock

Results:• Intermediate and high

serum lactate significantly associated with mortality regardless of the presence of shock or other organ dysfunction

• A single serum lactate seems to risk-stratify patients independent of organ dysfunction or hemodynamic instability

Mikkelsen, Mark et al CCM 2009 Vol 37 No 5

24

• Start intravenous antibiotic therapy within the first hour of recognition of severe sepsis after

Antibiotic Therapy

obtaining appropriate cultures (1D) for Septic shock (1B)

• Board spectrum: include one or more agents active against likely bacterial/fungal pathogens, & with good penetration into presumed source (1B)( )

• Reassess regimen daily to optimize efficacy, prevent resistance, avoid toxicity & minimize costs. (1C) Kreger BE. Am J Med 1980;68:344-355.

Ibrahim EH. Chest 2000;118:146-155.Hatala R. Ann Intern Med 1996;124-717-725.

Dellinger, et. al. Crit Care Med 2008, 36: 296-327.

Mortality as a Function of Adequacyof Empiric Antimicrobial Therapy

Inadequate TherapyP<0.001

Inadequate Therapy

Adequate Therapy60

50

40

30

P<0.001

All causes Infection-related

20

10

0

Kollef MH, et al. Chest 1999;115:462-74.

25

Initiation of Inappropriate Antimicrobial Therapy Results in a Fivefold Reduction of Survival in Human Septic Shock

• Objective: determine the impact of the initiation j pof inappropriate antimicrobial therapy on survival to hospital discharge of patients with septic shock

• Retrospective review of 5,715 patients from 22 different hospitals in Canada, US and Saudi pArabia

• Data collected from 1996-2005

Kumar A. et al.ChestChest, 2009; 136; 1237, 2009; 136; 1237--12481248

Initiation of Inappropriate Antimicrobial Therapy Result in a 5-Fold Reduction of Survival in Human Septic Shock

• 5,715 patients in septic shock in threeseptic shock in three countries

• 55% of cases were from community acquired infection

• Decrease in survival with inappropriate initial antibiotics was fivefold

Kumar A. et al.ChestChest, 2009; 136; 1237, 2009; 136; 1237--12481248

26

Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in

human septic shock

• 2,154 septic shock patientspatients

• Effective antimicrobial administration within the 1st hour of documented hypotension was associated with increased survival in patients with septic shockseptic shock.

• Each hour of delay over the next 6 hours was associated with an average decrease in survival of 7.6% (range 3.6-9.9%)

CCM 2006 Vol. 34 No.6

Antibiotic Challenges

Appropriate selection – determined based upon pp p pconsensus guidelines and pathogen sensitivity at your institution

Timing issues How? Delivery time challenges of antibiotics

Possible solutions

27

ProtocolizedProtocolized resuscitation should begin as soon as resuscitation should begin as soon as sepsis ind ced tiss esepsis ind ced tiss e h poperf sionh poperf sion is recogni edis recogni ed

Initial Resuscitation (1C)

sepsis induced tissue sepsis induced tissue hypoperfusionhypoperfusion is recognizedis recognizedoror

Elevated Serum lactate identifies tissue Elevated Serum lactate identifies tissue hypoperfusionhypoperfusion in patients at risk who are not in patients at risk who are not hypotensivehypotensive

Initial fluid challenges be started at Initial fluid challenges be started at >> 1000 1000 mLmL or or 300300--500 500 mLmL of colloid over 30 minutes (1of colloid over 30 minutes (1C)

Rivers E. N Engl J Med 2001;345:1368-77.Dellinger, et. al. Crit Care Med 2008, 36:296-327.

-

Early Goal Directed Therapy

E l G l Di t d

Methodology: 263 severe sepsis patients

• Early Goal-Directed Therapy (EGDT)– Continuous ScvO2

monitoring & tx with fluids, blood, inotropes &/or vasoactives to maintain:ScvO2 >70% SaO2 >

• Standard Therapy

– CVP > 8-12

– MAP > 65

– UO > .5ml/kg/hr

ScvO2 >70%, SaO2 >93%, Hct > 30%, CI/VO2CVP > 8-12MAP > 65UO > .5ml/kg/hr

Rivers et. al. N Engl J Med. 2001;345;19:1368-1377.

28

49.2%

6028-day Mortality

Early Goal-Directed Therapy Results

NNT = 7-849.2%

33.3%

10

20

30

40

50 P = 0.01*

0

10

Standard Therapyn=133

EGDTn=130

*Key difference was in sudden CV collapse, not MODS

Rivers E. N Engl J Med 2001;345:1368-77.

Evidence of Early Goal Directed Therapy

• First 6 hours of EGDT:

– 1500cc more fluid

– 64% received blood products vs. 18.5%

– 13.7% received inotropes vs. 0.8%p

– No difference in vasopressor use or mechanical ventilation

Rivers et. al. N Engl J Med. 2001;345;19:1368-1377.

29

Early Goal-Directed Therapy:SSC Recommendations

• Goals of therapy within first 6 hours are: (1C)

• Central Venous Pressure 8 - 12 mmHg

• Mean arterial pressure 65 mmHg

• Urine output 0.5 mL/kg/hr

• ScvO2 70%; if not achieved with fluid it ti d i fi t 6 h (2C)resuscitation during first 6 hours (2C)

- Transfuse PRBC to hematocrit >30% and/or

- Administer dobutamine (max 20 mcg/kg/min) to goal

Dellinger RP, et al. Crit Care Med. 2008;36:296-327.

Occult Tissue Hypoxia

• Tissue hypoxia is often occult, reaches an advanced and lethal stage before its presence isadvanced and lethal stage before its presence is known and resuscitation is attempted.

• Vital signs are inadequate for detecting global tissue hypoxia and not adequate as a resuscitation end point.

• Up to 50% of patients resuscitated from shock h ti d l b l ti h imay have continued global tissue hypoxia

(elevated lactate and decreased ScvO2) despite normalized vital signs and central venous pressure.

Source: Rady and Rivers, Am J Emerg Med 1996; Rivers et al. Curr Opin Crit Care 2001

30

Multicenter Study of Central Venous Oxygen Saturation as a Predictor of Mortality in Patients With Sepsis

• Objective: – Primary: an abnormal (both low and high) ScvO2 isPrimary: an abnormal (both low and high) ScvO2 is

associated with increased mortality in emergency department (ED) patients with septic shock.

– Secondary : determine whether the initial ScvO2 or the maximum ScvO2achieved was associated with mortality.

• 619 patients from 4 hospitals; prospectively ll t d d tcollected data

Pope; et al j.annemergmed.2009

Multicenter Study of Central Venous Oxygen Saturation (ScvO2)as a Predictor of Mortality in Patients With Sepsis

Maximum ScvO2 in 6 hours relates to mortality

Considering the maximum ScvO2 achieved in the ED, thepresence of both hypoxia and hyperoxia was associated with a

Pope; et al j.annemergmed.2009

was associated with ahigher mortality rate compared with that of the normoxia group

31

This meta-analysis evaluates the treatment effect of using a quantitative resuscitation strategy in the treatment of patientswith sepsis.

Using pooled data from nine studies that randomizeda total of 1001 subjects, we found the magnitude of the decrease in mortality (OR 0.50 with the upper limit 95% CI 0.69) was profound when the resuscitation strategy was implemented early.

CCM, October 2008

32

Peer Review Publications

BeforeBefore 11041104 AfterAfter 11751175

Rivers, 2001

Abstracts and Publications

Abstracts

Publications

1 of every 6 Patients

0.0 2.5 5.0 7.5 10.0

Number Need To Treat

4125 Before4125 Before 3328 After3328 After

33

Septic Shock Clinical Pathway

Vasopressors

• Recommend that MAP be maintain > 65 mmhg (1C)

• Ideally adequate fluid resuscitation should be achieved before asopressors and inotropes are sed b t sebefore vasopressors and inotropes are used, but use early in septic shock may need to occur. When it does the goal should be to try and wean with continuing fluid resuscitation.

• Norepinephrine or dopamine as first choice. (1C)

• Epinephrine, phenylephrine or vasopression should not ( C)be used as the initial vasopressor. (2C) Vasopresion may

be added to norepinephrine at 0.03 units/min.

• Suggest that epinephrine be the first chosen alternative. (2B)

• Low dose dopamine not be used for renal perfusion. (1A)Dellinger RP, et al. Crit Care Med. 2008;36:296-327

34

Vasopressin vs Norepinephrine Infusion in Septic Shock

VASST Study• Design: Multicenter randomized double-Design: Multicenter, randomized, double

blinded• Population: 778 patients with septic shock and

were receiving a minimum of 5mcq/min of norephinephrine (or equivalent) for 6 hours (excluded pts with underlying heart disease)

Methods:Received either low dose vasopressin• Methods:Received either low dose vasopressin (0.01-0.03U per minutes) or norepinephrine in addition to open-label vasopressors

• End point: 28 day mortality

Russell et al NEJM, 2008; Vol. 58, No 9

VASST Study Results

• No significant difference in 28 day or 90 day mortality between the two groups

A ti t h h d l ti h k(– Among patients who had less severe septic shock(on norepinephrine between 5-15 mcq/min) there was a trend toward improved mortality with vasopressin (hypothesis generating)

• No significant difference in rates of organ dsyfunction between the two groups

• No significant difference in overall rates of serious adverseNo significant difference in overall rates of serious adverse events between the two groups– Trend toward higher rate of cardiac arrest in

norepinephrine group– Trend toward higher rate of digital ischemia in the

vasopressin group

35

3rd-Tier: Implementation of Evidence-Based Sepsis Bundles


Implementation of the Sepsis Bundle with protocol & order sets




Management Bundle(To be accomplished as soon as possible and scored over first 24 hours):

Low-dose steroids administered for ti h k i d ith

Resuscitation Bundle(To be accomplished as soon as possible and scored over first 6 hours):


Blood cultures obtained prior to antibiotics d i i t d (1C) septic shock in accordance with a

standardized ICU policy. (Given to patients who respond poorly to fluids or vasopressors) (2C)



administered. (1C)





Apply vasopressors for hypotension not responding to initial fluid resuscitation to

Bleeding is the most common adverse effect associated with Xigris therapy.See Important Safety Information in this presentation.

Tidal volume 6 ml/kg (1B) Inspiratory plateau pressures < 30 cmH2O for mechanically ventilated patients. (1C)





if ScvO2 not > 70% blood or dobutamine (2C)

Adapted from the revised guidelines: CCM 2008;36:296-327.

36

Tier III: Implementation of Sepsis BundlesMilestones and Checklist

• Develop easy to use order sets (ED and ICU should be th ) i d b b dlthe same), organized by bundle

• Identify resistance and barriers to bundle implementation and develop solutions

• Identify tools to assist bedside staff to implement bundles (algorithm, pathway, checklist, pocket cards ect)

• Identify equipment needs and make capital requestsy

• Develop triggers/processes to alert staff when time to move from resuscitation to management bundle

• Define educational plan for all staff:

• Develop implementation plan

Septic Shock Clinical Pathway

37

Tier III: Sepsis Bundle ImplementationMilestones and Checklist

• ED is actively participating and have completed the following:ED is actively participating and have completed the following:

– Defined who will place central line when pt has lactate>4 or still hypotensive after initial fluid bolus

– Nurses in ED are competent in monitoring CVP and ScvO2

– There is sufficient nursing staff to handle the acuity and i t it f th ti t i th EDintensity of these patients in the ED

– Define process for ED to ICU handoff

– If ED LOS is longer than 6 hrs, need to be able to implement the management bundle

Clinical Scenario II: Early identification and Intervention

• 88 year old, 51.6kg,white, female admit from ED; resided in ECF


• Chief Complaint: rib pain, chest congestion and SOB

• Awake, alert and oriented, slight combativeAwake, alert and oriented, slight combative (history of combative behavior)

The Rest of the Story

38

Clinical Scenario II : Early Identification and Intervention-ER

• Labs:WBC: 11 5– WBC: 11.5

– Hgb: 15.8– Hct: 47.4– BUN: 28 Creatinine:1.6– Glucose:158– BNP:78 (moderate CHF); troponin:0.03– Lactic acid: 4.6Lactic acid: 4.6– U/A: positive for bacteria– ScvO2: 49.1%– Blood cultures X 2 drawn

Clinical Scenario II : Early Identification and Intervention-ER

• CXR: RLL consolidation

• Additional Interventions:– Broad spectrum antibiotics given within 3 hours of

presentation– Lactic acid >4mmol/L so CVP inserted– Fluid resuscitation continued – Foley inserted

• Received total of 3 Liters of NS during 3 hour ED stay

• ED diagnosis: Severe sepsis, Pneumonia , UTI, CHF

• Transferred to MICU

39

M B dlManagement Bundle Components

• Recombinant human Activated Protein C [Drotrecogin alfa (activated)] is recommended in

Recombinant human Activated Protein C (2B)

[Drotrecogin alfa (activated)] is recommended in patients at a high risk of death (APACHE II score 25, or Sepsis-induced multiple organ failure) if there are no contraindications.

• Within 30 days of surgery with the above indications (2C)

• Drotrecogin alfa (activated) is not indicated in adultDrotrecogin alfa (activated) is not indicated in adult patients with severe sepsis and lower risk of death. (1A)

• Relative contraindications/warnings should be consider

Dellinger, et. al. Crit Care Med 2008, 36: 296-327

40

PROWESS 28-Day Mortality –High Risk of Death Patients*

Drotrecogin Alfa (Activated) In Severe Sepsis: PROWESS Results

29% d ti i

44%

31%30%

40%

50%

60%

Absolute Risk Reduction

= 13%

Mo

rtal

ity

Rat

e

reduction in relative risk of death with Xigris†

*as defined by APACHE II 250%

10%

20%

Placebo Drotrecogin alfa

(activated)

M

Safety Profile

Low incidence of serious bleeding events*

Rate of serious bleeding events during infusion in high-risk patients:patients:

PROWESS: 2.2% (9 of 414) in drotrecogin alfa (activated) patients vs 0.7% (3 of 403) in standard therapy patients

Rate of ICH in high-risk patients during infusion: PROWESS: 0.2% (1 of 414) in drotrecogin alfa (activated) patients

Associated with severe thrombocytopenia (platelet count < 30,000/mm3)†

Not associated with other adverse events*Serious bleeding events were defined as any intracranial hemorrhage, any life-threatening bleeding, any bleeding event requiring the administration of ≥3 units of packed red blood cells per day for 2 consecutive days, or any bleeding event assessed as a serious adverse event.

†At the time of enrollment in the PROWESS study, the patient had a platelet count above 30,000/mm3. The patient’s platelet count fell to less than 30,000/mm3 after drotrecogin alfa (activated) therapy was initiated.

Data on file, Eli Lilly and Company

41

CONTRAINDICATIONS

Important Safety InformationImportant Safety Information

Drotrecogin alfa (activated) increases the risk of bleeding. Drotrecogin alfa (activated) is contraindicated in patients with the following clinical situations in which bleeding could be associated with a high risk of death or significant morbidity

– Active internal bleeding– Recent (within 3 months) hemorrhagic stroke– Recent (within 2 months) intracranial or intraspinal

surgery, or severe head trauma– Trauma with an increased risk of life-threatening

bleeding

morbidity.

– Presence of an epidural catheter– Intracranial neoplasm or mass lesion or evidence of

cerebral herniation

Drotrecogin alfa (activated) is contraindicated in patients with known Drotrecogin alfa (activated) is contraindicated in patients with known hypersensitivity to drotrecogin alfa (activated) or any component of this hypersensitivity to drotrecogin alfa (activated) or any component of this product.product.

Low Tidal Volume Ventilation: SSC Recommendations

• Target tidal volumes to < 6 mL/kg (predicted body weight) in patients with ALI/ARDS (1B)

Initial upper limit goal for plateau pressures in a• Initial upper limit goal for plateau pressures in a passively inflated patient be < 30 cm H2O (1C)

• Hypercapnia can be tolerated in patients with ALI/ARDS if required to minimize plateau pressures and tidal volumes (1C)

• Recommend that positive end expiratory pressure be set as to avoid extensive lung collapse at end-be set as to avoid extensive lung collapse at endexpiration (1C)

• Suggest prone positioning in ARDS patients requiring potentially injurious levels of FiO2 or plateau pressures in facilities that have experience with the practice (2C)

Dellinger RP, et al. Crit Care Med. 2008;36;296-327.

42

Corticosteroids In Septic Shock:SSC Recommendations (2C)

• Intravenous corticosteroids should only be given to adult septic shock patients after it has been confirmed that their blood pressure is poorly responsive to fluid resuscitation and vasopressor therapy

• Suggest that the ACTH stimulation test should not be used to identify the subset of adult with septic shock who should receive hydrocortisone. (2B)

We suggest that patients with septic shock should not• We suggest that patients with septic shock should not receive dexamethasone if hydrocortisone is available. (2B)– Administer intravenous hydrocortisone <300 mg daily (1A)

– ludrocortisone is optional if hydrocortisone is used (2C)


Hydrocortisone Therapy for Patients with Septic Shock

• Design: Multicenter, randomized, double-blind placebo-controlled trialblind, placebo controlled trial

• Population: 499 patients with septic shock—BP<90 systolic despite adequate fluid replacement or vasopressors for at least one hour (onset of shock within previous 72 hrs)

• Method: 2 groups: one group received 50mg h d ti 6 h f 5 d thhydrocortisone every 6 hrs for 5 days, then tapered; other group received a placebo.

• End Point: 28 day mortality

Sprung, NEJM,2008; Vol 358 No 2

43

Hydrocortisone Therapy for Patients with Septic Shock--Results

• No significant difference between 2 study groups in rate of death at 28 days (no matter if responded or y ( pnot to corticotropin)

• Duration of time to reversal of shock was significantly shorter among all pts receiving hydrocortisone (3.3 days vs 5.8 days; p<0.001)

• Pts in this study who has a SBP of< 90mmHg at 1 day after fluid and vasopressor resuscitation had mortality of 56% if received placebo and mortality ofmortality of 56% if received placebo and mortality of 44.9 if received hydrocortisone (difference of 11.4%)—similar to Annane et al results.

• In hydrocortisone group there was an increased incidence of superinfections, including new episodes of septic shock

Sprung, NEJM,2008; Vol 358 No 2

Glucose Control: SSC Recommendations

• Initial stabilization of patients with severe sepsis and hyperglycemia who are admitted to the ICU receive IVhyperglycemia who are admitted to the ICU receive IV insulin therapy to reduce blood glucose levels. (1B)

• Use of a validated protocol and target glucose levels to < 150 mg/dL range. (2C)

• All patients receiving IV insulin should receive a glucose calorie source and blood glucose values should be initially assesses every 1-2 hrs then q 4should be initially assesses every 1 2 hrs, then q 4 hours after stabilization. (1C)

• Low glucose levels obtained by Point of Care testing should be interpreted with caution (1B)


44

Intensive versus Conventional Glucose Controlin Critically Ill Patients

Methodology:– Randomized, controlled, prospectiveRandomized, controlled, prospective– 42 hospitals in Australia, New Zealand and Canada– 6,104 patients– Inclusion criteria: expected ICU stay > 3days; adult

in medical or surgical ICU– Exclusion: admission to ICU > 24 hrs prior toExclusion: admission to ICU 24 hrs prior to

assessment, imminent death or expected to eat within 24 hrs

– Primary endpoint is death from any cause within 90 days

The NICE-SUGAR Study InvestigatorsNEJM 3-09 Vol. 360 No.13


Intensive Glucose Control

Conventional Glucose ControlControl

• n=3054• Target blood glucose: 81-

108mg/dl• Insulin gtt titrated using

study treatment algorithm• Avg BG: 115 +/- 18

Control• N=3050• Target blood glucose: <180• Insulin gtt started if BG >180,

then turned off if glucose < 144

• Insulin gtt titrated using study t t t l ith• Avg insulin dose: 50.2

units/day• Avg # days on insulin: 4.2• % with hypoglycemic

event (BG,40mg/dl): 6.8%

treatment algorithm• Avg BG: 144 +/- 23• Avg insulin dose: 16.9 u/day• Avg # days on insulin: 4.3• % with hypoglycemic event

(BG,40mg/dl): 0.5%NICE-SUGAR Investigators, N Engl J Med;2009:1283-97.

45


Results:•• Mortality rate: 27 5% inMortality rate: 27 5% in•• Mortality rate: 27.5% in Mortality rate: 27.5% in

Intensive control group Intensive control group vsvs 24.9% in 24.9% in Conventional control Conventional control group (p=0.02)group (p=0.02)

•• Baseline Baseline characteristics for bothcharacteristics for bothcharacteristics for both characteristics for both groups similar, except groups similar, except Intensive control group Intensive control group had more pts with had more pts with severe sepsis and on severe sepsis and on corticosteroidscorticosteroids

NICE-SUGAR Investigators, N Engl J Med;2009:1283-9

The NICE-SUGAR Study: Results (cont)

Subgroups:Subgroups: Patients with corticosteroids or trauma showed trend of doing better with intensive glucose control vs conventionalcontrol vs conventional

NICE-SUGAR Investigators, N Engl J Med;2009:1283-97.

46


Limitations• Use of subjective criterion (expected LOS in ICU) for

inclusion• Lack of blinding• Glucose levels in Intensive group substantially

above target range• Significant number of patients in which study

was discontinued prematurely—data stillwas discontinued prematurely data still included

• Was the study treatment algorithm flawed—resulting in more hypoglycemia?

NICE-SUGAR Investigators, N Engl J Med;2009:1283-97


Questions:• Why no difference in LOS or organ dysfunction in y g y

intensive group with higher mortality?• Was the increased mortality simply related to

hypoglycemia? Need further exploration of the precise causes of death in pts

Post hoc analysis needs to be done to help answerPost hoc analysis needs to be done to help answer these questions

NICE-SUGAR Investigators, N Engl J Med;2009:1283-97.

47

Clinical Scenario II: Early identification and intervention

• 88 year old, 51.6kg,white, female admit from ED; resided in ECF


• Chief Complaint: rib pain, chest congestion and SOB

• Awake, alert and oriented, slight combativeAwake, alert and oriented, slight combative (history of combative behavior)

The Rest of the Story

Clinical Scenario II : Early Identification and Intervention--MICU

• Additional Interventions: Day 1– Continued fluid resuscitation—7 L

L d– Low dose vasopressor– Low dose steroids– Remained on 2 L nasal canula– Not eligible for Xigris (renal failure resolved and vasopressor

weaned off within 12hours after ICU admission)• Labs:

– ScvO2: 72 8 (after resuscitation)ScvO2: 72.8 (after resuscitation)– Lactic acid: 4 hours after ICU admission: 6.7

12 hours after ICU admission: 3.0

Bleeding is most common adverse effect associated with Xigris therapy, please see important safety information in this presentation

48

Clinical Scenario II : Early Identification and Intervention

• Day 2:

– Vasopressor weaned offp

– Lasix to assist with fluid mobilization

– Lactic acid: 3.0

• Day 3:

– Lactic acid: 1.2

– O2 sat 93% on room air

– Central line discontinued

• Transferred to intermediate care on Day 3

• Discharged from hospital on day 7

Measuring

Fourth Tier:Measuring Process and Outcomes Changes


Implementation of the Sepsis Bundle

Success



49

Tier IV: MeasurementMilestones and Checklist

• Define outcome and process data elements that• Define outcome and process data elements that will be collected

• Develop and implement a prospective data collection process

• Revise and update goals and action plan as neededneeded

• Execute implementation plan

ChallengesChallenges1.1. Finding the patientsFinding the patients

Overview

2.2. Physician BuyPhysician Buy--inin3.3. Reaching resuscitation goals in 6 hoursReaching resuscitation goals in 6 hours

Sustaining and Improving: StrategiesSustaining and Improving: Strategies◦◦ Focused Incremental GoalsFocused Incremental Goals◦◦ Real time feedback and educationReal time feedback and education◦◦ Creating sense of urgency: ‘Sepsis Alerts’ ‘CodeCreating sense of urgency: ‘Sepsis Alerts’ ‘Code◦◦ Creating sense of urgency: Sepsis Alerts Code Creating sense of urgency: Sepsis Alerts Code

SepsisSepsis◦◦ Prospective data collectionProspective data collection◦◦ Continuous Improvement strategies toolsContinuous Improvement strategies tools◦◦ Sharing storiesSharing stories

50

1. Finding the patients

Sepsis Management: Challenge #1

1. Finding the patients– Understand sepsis continuum

– Routine screening-and with condition change

– Redefine what a ‘shock patient’ looks like

• Lack of ScreeningN d t fi t i ED ICU d RRT

Challenge #1: Finding the patients

– Need to screen first in ED, ICU and RRT

– Then expand housewide—all units

– Rountine: upon admission, every shift and with change in patient conditions

– Provide clear next steps for positive severe– Provide clear next steps for positive severe sepsis screen

51

Redefining what a ‘septic shock’ patient looks like

Challenge #1: Finding the patients

Before NOW

Supine in bed Sitting up in bedSupine in bed Sitting up in bed

Ventilator Nasal canula

Fluids wide open IV boluses

Increasing vasopressors Weaning vasopressors

Minimally responsive Awake

“Don’t look sick enough to be in ICU or to have a central line”

Must correct this misperception

• Unit sepsis champions

• Sepsis coordinator

Strategies: Finding the Patient

Sepsis coordinator

• ED and ICU rounding

• RRT screen on every call

• Prospective patient log

• Discuss sepsis screen as part of Multidisciplinary Rounds

• Reports• Patients who screened positive

• Lactate

52

Unit Pt # Point of Entry

Date of Septic

Time of Septic

Data Obtained

Data Complete

Comments / Follow-up

Finding the Patients:Prospective Patient Log

Entry Septic Shock Dx

Septic ShockDx

Obtained Complete Follow-up

Strategies:

Sepsis Management: Challenges #2Physician Buy-in

Strategies:◦ Redefining what a ‘septic shock’ patient looks like◦ Physician Champions-ED and ICU Part of sepsis team Follow up with physician when bundles not followed

◦ ED and ICU rounding◦ Unit sepsis champions◦ Sepsis coordinator◦ Sepsis coordinator◦ Data--- Often and detailed Physician specific

◦ Administrative support

53

• Process measure data collection/analysis– Which component is it? Getting line in CVP MAP or

Must Understand why?

Which component is it? Getting line in, CVP, MAP or ScvO2?

• Talk with staff

• Use quality tools: eg fishbone

Severe Sepsis Bundle Implementation Results

54

Focused incremental goals

Challenges #3: Not Meeting Resuscitation Goals in 6 hrs

– First hour of care• Lactate, blood cultures, antibiotics and 20ml/kg fluid bolus

– Resuscitation goals within 6 hours• CVP greater than or equal to 8mmHg

• MAP greater than or equal to 65mmHg

• ScvO2 greater than or equal to 70 %

Work on resuscitation bundle then focus on management bundle

First Hour of Care

55

First Hour

Hours 2-6

• Independent checks

Sustaining and Improving:Strategies

Independent checks– Checklists, pathway

– Multidisciplinary rounds

• Real time feedback and on-going education– Unit rounds– Unit rounds

– Unit champions

– Staff meetings

– Orientation---RN and residents

– Quarterly with current staff

56

• Creating sense of urgency

Sustaining and Improving:Strategies

• Creating sense of urgency– ‘Code Sepsis’ or ‘Sepsis Alert’

– Staffing ratio for initial 6 hours of ICU or ED care

– Clock on the door

– Protocol Watch

• Patient log

Sustaining and Improving:Prospective Data Collection

• Time Zero:– Diagnosis of Severe Sepsis with hypoperfusion or

shock: patients with lactate > 4mmol/L OR continued hypotension after fluid bolus of minimum of 20ml/kg

• Database

D t i d l i• Data review and analysis

57

• Rapid cycle improvement

Sustaining and Improving:Continuous Improvement Strategies

p y p– Test small incremental improvements

• Link lactate draws with all blood cultures

• Nurse protocol when patient screens positive

• Standard antibiotics ready on the unit

• Use examples of hospital patients in case

Sustaining and Improving:Share Stories and Report Data

• Use examples of hospital patients in case studies for education of staff

• Data reviewed at sepsis team meetings

• Data-both process and outcome reviewed at:– Team meetings

D i– Department meetings

– Quality meetings

– Leadership meeting

– Hospital board meetings

58

Surviving Sepsis Campaign

• 252 hospitals in 18 countries

• Data from January 2005-March 2008• Data from January 2005-March 2008

• Observational; time series

• Baseline is first quarter data was collected

• Use of standardized screening toolUse of standardized screening tool

• Excluded site if less than 20 patients or less than 3 months of results

Surviving Sepsis CampaignResults

• Final Sample Size: 15,022 patients p , pfrom 166 sites (95% of total)

–North America: 58%

–Europe: 31%

South America: 10%–South America: 10%

59

Surviving Sepsis CampaignResults

Entry Point Subjects Mortality (hosp)

ED 52% 27.6

ICU 12.8% 41.3

Ward 34 8% 46 8Ward 34.8% 46.8

Hospital mortality went from 37% to 30%7% ARR; 19% RRR; p< 0.007

Surviving Sepsis CampaignBundle Compliance

Bundle Baseline 2 yearBundle Baseline 2 year

Resuscitation 10.9 % 31.3 %

Management 18 % 36 %

Risk Adjusted Hospital Mortality decreased by 5.4%20 % improvement in compliance with bundles

60

A Prospective MultiA Prospective Multi--Center Collaborative StudyCenter Collaborative StudyBefore and After Implementation of anBefore and After Implementation of anBefore and After Implementation of anBefore and After Implementation of an

Early Sepsis InitiativeEarly Sepsis Initiative

The Multi-Center Severe Sepsis &The Multi-Center Severe Sepsis & Septic Shock Collaborative Group

Presented by Emanuel Rivers at the World Federation of Critical care Medicine, Florence Italy 08/09

The Multi-Center Severe Sepsis andSeptic Shock Collaborative Group

11 Medical Centers:11 Hospitals (6 Tertiary / 5 Community)

7 St t

Multi-center Severe Sepsis & Septic Shock Collaborative

7 States

Post-Sepsis QualityInitiative Group

(Treatment Group)

4000 Treatment Patients

Pre-Sepsis QualityInitiative Group

(Historical Control Group)

1600 Control Patients

Severe Sepsis

1000 Patients

Septic Shock

600 Patients

Septic Shock

3000 Patients

Severe Sepsis

1000 Patients

Presented by Emanuel Rivers at the World Federation of Critical care Medicine, Florence Italy 08/09

In this intention-to-treat evaluation, all patients including DNR were examined.

61

Demographics & Baseline Criteria

DemographicsPre-

implementationPost-

implementationP-value

Age (SD), yr 63.9 (16.6) 61.01 (17.3) 0.0001

Sex, % male 52.5% 55.5% 0.0422

Baseline (SD)( )

Heart rate, bpm 107 (25) 109 (26) 0.0405

Systolic BP, mm Hg 100 (29) 102 (29) 0.1657

Shock index (HR/systolic BP)

1.15 (0.40) 1.15 (0.42) 0.9442

62

Baseline Criteria

Baseline (SD)Pre-

implementationPost-

implementationP-value

p p

MAP, mm Hg 69.9 (20.41) 69.7 (20.20) 0.8141

CVP, mm Hg 10.6 (6.92) 10.9 (6.71) 0.5261

ScvO2, % 69.0 (16.04) 70.3 (13.44) 0.2725

Lactate, mmol/L 5.02 (4.68) 4.3 (3.58) 0.0001( ) ( )

Organ Dysfunction (SD) P-value

Baseline APACHE II score

21.1 (7.95) 23.4 (7.62) 0.0001

24-hour APACHE II score

24.2 (9.09) 19.5 (8.50) 0.0001

Results• There were 5467 total patients enrolled, 1446 pre-

and 4021 post-implementation.

The post implementation group had higher baseline• The post-implementation group had higher baseline APACHE II scores with a 8.45% higher predicted mortality.

• In-hospital mortality was 39.12% before implementation and 28.97% after implementation (P< 0.001) for an absolute risk reduction of 10.15% and a relative risk reduction of 26 0%a relative risk reduction of 26.0%.

• Post-implementation secondary outcomes included improved organ dysfunction and lactate clearance; less vasopressor use and mechanical ventilation; shorter hospital length of stay

63

Limitations

• This study was designed as an observational, unblinded, nonrandomized, uncontrolled study.

• Although each study center attempted to use consistent criteria for identifying patients with SS/SS in the pre- and post-implementation groups, variability in diagnosis and chart records over time may have led to heterogeneity between the pre-and post-implementation populations.

Conclusions

• Implementation of sepsis initiatives across various clinical and geographic settings is associated with significant reductions in mortality, organ dysfunction,significant reductions in mortality, organ dysfunction, and healthcare resource consumption.

• This multi-center real world adoption of early sepsis best practice externally validates previous studies and supports generalized application in the management of severe sepsis and septic shock patients.

• Continued emphasis should be placed on overcoming logistical, institutional, and professional barriers to implementation of sepsis initiatives.

64

Keys to Success

• Team in place with key stakeholders overseeing implementation• Project coordinator with lead clinical staff on each unit• Sepsis resource/coordinator rounds frequently on units• Strong physician leadership on team• Reminders to staff through use of bedside sepsis

tools/checklist• Empowerment of nursing staff to prevent errors• Administrative support to help manage barriers• Review data monthly to identify opportunities for

improvement• Support from state-wide collaborative/surviving sepsis

campaign

EDUCATION, PROCESS, MEASUREMENT & ACCOUNTABILITY

The Nurses Role• Early recognition of

patients with signs of sepsissepsis

• Early initiation of evidence based practice therapies appropriate for your area of practice (antibiotics, fluids/blood &(antibiotics, fluids/blood & pressors)

• Swift disposition to care areas where the rest of the bundle can be started.

65

Be Courageous

We all are responsible for the safety of our patients……Own the y pIssues

•“If not this, then what??”•“If not now, then when?”•“If not me, then who??”

Sit it Out or Dance

Documents

Overview - Kathleen Vollman [Compatibility Mode].pdf · diit d(1C) standardized ICU policy. (Given to patients who respond poorly to fluids or vasopressors) (2C) Drotrecogin alfa