Surviving Sepsis Campaign Updates

Transcription

1 Surviving Sepsis Campaign Updates Emily Kauffman, DO, MPH OSU Wexner Medical Center

2 DISCLOSURE STATEMENT It is the policy of the American Osteopathic Association (AOA) and Ohio University Heritage College of Osteopathic Medicine (OU-HCOM) to insure balance, independence, objectivity, and scientific rigor in all its individually sponsored or jointly sponsored educational programs. All participants in any continuing education program are expected to disclose to the program audience any real of apparent conflict(s) of interest that may have a direct bearing on the subject matter of the continuing education program. This pertains to relationships with pharmaceutical companies, biomedical device manufacturers, or other corporations whose products or services are related to the subject matter of the presentation topic. The intent of this policy is not to prevent a speaker with a potential conflict of interest from making a presentation. It is merely intended that any potential conflict should be identified openly so that the listeners may form their own judgments about the presentation with the full disclosure of the facts. It remains for the audience to determine whether the speaker s outside interests may reflect a possible bias in either the exposition or the conclusions presented.

3 OBJECTIVES 1). Clarification on current sepsis terminology as it applies to current research, including the use of the quick Sequential Organ Failure Assessment (qsofa) for rapid bedside assessment 2). Updates in the approach to initial resuscitation, antibiotic selection and source control 3). Adjunctive measures to assist with ongoing inpatient management and perceived challenges

4 Why Sepsis? Life threatening dysfunction affecting more that 1 million patients/year in the US Observational study of 29,470 patients worldwide diagnosed with sepsis noted a clinically significant decrease in odds of hospital mortality (OR, 0.96; 95%CI, ; p<.001) while participating in the Surviving Sepsis Campaign initiative 1 Cause of death for 1 in 4 people worldwide In 2011, accounted for more than $20 billion (5.2%) of total US hospital costs 2 Similar to polytrauma, acute myocardial infarction, or stroke; initial management improves outcomes

5 Surviving Sepsis Campaign Launched in 2002 European Society of Intensive Care Medicine (ESICM) and Society of Critical Care Medicine (SCCM) Original guidelines published in 2004, revised in 2008, 2012, and most recent (2016) updates released on January 18 th, 2017 in Critical Care Medicine 1 55 international experts representing 25 international organizations 93 recommendations, 32 strong, 39 weak, and 18 best practice statements 4

6 Surviving Sepsis Campaign Goals Building awareness of sepsis Improving diagnosis and recognition Defining and increasing the use of appropriate treatment and care Educating health care professionals Improving post-intensive care unit care Developing guidelines of care Implementing performance improvement program 1

7 Sepsis-3 (3 rd International Consensus Definitions for Sepsis and Septic Shock) 2 Released February 23, 2016 in JAMA Task force of 19 different specialists, established January 2014 Goal to differentiate sepsis from uncomplicated infection, acknowledging the complex pathophysiology behind organ dysfunction Need to update definitions (originated in 1991), and provide scoring systems for organ dysfunction (Sequential Organ Failure Assessment (SOFA) and (qsofa)) Eliminating the terms severe sepsis and SIRS Too many terms (severe sepsis, sepsis syndrome, septicemia) leading to confusion in ICD-10 coding

8 SIRS (Systemic Inflammatory Response Syndrome) 2 or more of: Temp>38 C or <36 C Pulse >90 bpm RR >20/min or P a CO 2 < 32mmHg WBC>12,000/mm 3 or <4,000/mm 3, or >10% immature bands

9 Sequential Organ Failure Assessment (SOFA) Scoring system used primarily by critical care physicians in place since 1996 Better documentation of organ dysfunction Sepsis-3 group introduced the quick SOFA (qsofa) to allow for rapid bedside assessment of patients at risk of clinical deterioration, predicts organ dysfunction, and in-hospital mortality qsofa may be less robust than SOFA in the ICU setting; however it may be obtained rapidly and repeatedly without lab testing 2 qsofa has been proposed to replace SIRS (Sepsis-3) 5

10 SOFA 6 categories Score 0 to 4 per category, with total score of 24 2 or more is a positive score 2 notes increasing severity of organ failure JAMA. 2016; 315(8): doi: /jama

11 Sequential (Sepsis-Related) Organ Failure Assessment Score (SOFA) SOFA (2 or more) PaO 2 /FiO 2 ( ) Platelets (<20 ->150) Bilirubin (1.2->12) MAP (<65mmHg) +/- pressors GCS (normal to <6) Creatinine, and UOP (normal to>5), <200 ml/hr Q (quick) SOFA (2 or more) Resp rate 22/min Altered Mental Status: GCS<15 SBP 100 mmhg Does not define sepsis, but 2 or more variables predict increased mortality (>10%) and prolonged ICU stays 6

12 qsofa Proposed bedside algorithm in JAMA article on Sepsis-3 JAMA. 2016; 315(8): doi: /jama

13 Controversy over qsofa Results have not been validated in a general population (ED, non-icu, inpatient setting) 7,8 In non-icu patients, SIRS and SOFA perform the same Predicts inpatient mortality, not immediate prognostics Less inclusive and concern for missing patients (less sensitivity) Delayed implementation due to ICD-10 Concern about confusion in educating non-academic centers 7

14 New Studies ED STUDY 8 (SIRS v SOFA v qsofa) Multicenter prospective cohort study of 879 patients in Europe from May- June 2016 in 30 ED s Overall in-hospital mortality was 8% 3% for patients with a qsofa <2 vs 24% with a score 2 qsofa performed better than SIRS, and severe sepsis in predicting inhospital mortality (AUROC curves) Matched sensitivity (70%) and specificity (79%) No added value with serum lactate ICU Study 9 (SIRS v SOFA v qsofa) Retrospective cohort analysis of 184,875 pts admitted to ICU s in Australia and New Zealand from SOFA score 2 greater prognostic accuracy for in-hospital mortality than SIRS or qsofa qsofa slightly better than SIRS 2 prior retrospective studies in 2016 from ED admissions to the ICU noted good prospective ability of qsofa to predict in-hospital mortality 8

15 Sepsis versus Septic Shock 2 Sepsis Life threatening organ dysfunction caused by a dysregulated host response to infection Organ dysfunction: 2 on SOFA, or qsofa for rapid bedside assessment Can be modified by pre-existing illness and chronic co-morbidities Same as severe sepsis Septic Shock Sepsis with profound circulatory, cellular, and metabolic abnormalities leading to greater mortality MAP 65 mmhg, requiring vasopressors, AND Serum lactate 2mmol/L despite adequate fluid resuscitation

16 Surviving Sepsis Updates 3 Initial Resuscitation Screening Diagnosis Antimicrobial therapy Source Control Fluids Vasopressors Steroids Blood products Immunoglobulins Anticoagulants/DVT prophylaxis Mechanical Ventilation Sedation Renal Replacement therapy Others: goals of care, nutrition, stress ulcer

17 Initial Resuscitation 30ml/kg crystalloid fluid bolus given in < 3 hours Subsequent fluids are determined dynamic variables such as bedside vitals (temp, BP, RR, P, UOP, possibly PaO 2, pulse pressure variability with leg raise) and guiding to normalize lactate, MAP 65 May use bedside cardiac ultrasound to assess shock status-if unclear Less emphasis on static variables: CVP, mixed venous oxygen saturation requiring CVP monitoring (weak recommendation) Changes based on PROCESS, PROMISE, and ARISE trials noting that early goal directed therapy (EGDT) versus usual care is not superior-so no resuscitation targets in place, removed static variables and replaced with dynamic measures 7

18 Screening and Diagnosis Recommendation for sepsis screening tools (qsofa), ongoing performance improvement Diagnosis: obtain appropriate cultures (blood, 2 sets: aerobic and anaerobic) before starting appropriate antibiotics (to be given within one hour); including other surveillance data as needed (UA, CXR, wound cx, line cx, body fluid, sputum, etc) If difficulties with IV access/venipuncture-antibiotics may still be given IM if needed with goal of < 1 hour

19 Antimicrobial Therapy Empiric broad-spectrum antibiotics (usually carbapenem, or extended range PCN/betalactamase inhibitor, or sometimes 3 rd generation cephalosporin) within one hour of recognition of sepsis Most common pathogens are gram negative, but likely will require 2 antibiotics targeted to site/organ of presumptive infection-tailoring to drug resistance, immunosuppression, local antibiograms and pseudomonas Ensure appropriate loading doses given increased volume of distribution in fluid resuscitation De-escalate as cultures return; typical treatment 7-10 days, with exceptions depending on type of infection Recommendation against combo therapy for neutropenic sepsis/bacteremia Procalcitonin-weak recommendation, best in pulmonary infections; may help stopping antibiotics when presentation is unclear

20 Source Control No specific changes More generic recommendations-stating any required source control intervention should be implemented as soon as medically and logistically practical after the diagnosis is made 3 If source is obvious, and able to be safely removed with alternative access obtained (temp lines: CVC, PICC, Foley)-then these sources may be removed; ideally within 6-12 hours after initial diagnosis

21 Fluids and Vasopressors Fluids Crystalloids (LR or NS) as initial fluid choice May use albumin for those patients that are requiring large amounts of IVF (weak recommendation) Vasopressors Norepinephrine is first line (strong) Vasopressin (up to 0.03 U/min) or epinephrine as second agent if needed (weak rec) Dopamine only for pts with low risk of tachyarrhythmias and bradycardia (weak) Dobutamine-persistent hypoperfusion, adequate fluid load, on vasopressors

22 Corticosteroids No significant changes Use only to treat septic shock unresponsive to IVF and vasopressors No more than 200 mg/day of IV hydrocortisone Taper once off vasopressors Avoid ACTH stim testing

23 Blood Products Consider transfusion of prbcs if Hb<7 g/dl (excluding MI, hemorrhage, severe hypoxemia) (strong) Avoid EPO no FFP (if no bleeding) Consider platelets if <10k (no bleeding), or 50k if active bleeding (weak)

24 Anticoagulation Anticoagulants Attempt to find an agent to reverse the DIC component of sepsis Xigris (recombinant activated protein C)-withdrawn (PROWESS-SHOCK trial) Looking into heparin, and thrombomodulin, but no recs Avoid antithrombin (bleeding risks) DVT/PE Prophylaxis Heparin or lovenox (LMWH), combined with mechanical if able Studies may show slight benefit of LMWH, however heparin was dosed BID, not TID

25 Mechanical Ventilation Low Tidal Volume 6mL/kg predicted body weight (based on ARDS data) Plateau pressure 30 cm H 2 O, HOB >30-45 aspiration precautions Consider CPAP mode as a recruitment maneuver; no formal recs on noninvasive ventilation Avoid PA catheters Daily spontaneous breathing trials (T-piece vs CPAP) and weaning protocols

26 Acute Respiratory Distress Syndrome (ARDS) Definition PaO 2 /FiO mild 200 moderate 100 severe Tips with ventilation Conservative fluids 4-6mL/kg PBW (tidal volume) Higher PEEP Proning if <150 Neuromuscular blockade 48 hours Plateau pressure 30 cm H 2 O

27 Other Topics Sedation: minimize as able (RASS, CAM-ICU scores) Glucose: treat if 2 measurements 180 mg/dl (target range mg/dL) Renal Replacement Therapy: CRRT or intermittent in sepsis with Acute Kidney Injury (AKI), hypervolemia, and/or oliguria (weak rec) Bicarbonate Therapy: avoid (if ph 7.15): tissue hypo-perfusion leads to lactic acidemia Stress Ulcer Prophylaxis: use H2 blocker or PPI in those at risk of GI bleeding Nutrition: early enteral feeding; post-pyloric feeding tube if needed Goals of Care: address early and often with families

28 Inpatient Management of Sepsis Challenges and Solutions

29 Challenges 10 Chronically ill patients making bedside diagnosis of sepsis more difficult qsofa may assist as can be used rapidly and repeatedly without labs CMS tracking adherence to sepsis bundles based on time (1, 3 and 6 hours) CMS tracking sepsis data since October 2015 Compliance with bundles is all or none High patient to provider ratio unlike the ED or ICU Delays exist in diagnosis, implementation and reassessment

30 Solutions Rapid bedside assessment qsofa; initiate RN driven protocols (ED and floor) Code SMART (Sepsis Management Alert Response Team) Designating departmental sepsis champion Best Practice Advisories (BPA)/pop-up sepsis order sets 10

31 Sepsis Bundles New guidelines state antibiotics within one hour Updates to these bundles will be released later in hour and 6 hour measures essentially unchanged, however reassessment will rely on dynamic assessment (CVP, mixed venous oxygen saturation will likely be removed)

32 Reassessment of Volume Status and Tissue Perfusion Either Repeat focused exam (after initial fluid resuscitation) including vital signs, cardiopulmonary, capillary refill, pulse, and skin findings OR Two of the following: CVP (old) ScvO 2 (old) Bedside cardiac assessment (cardiac ultrasound), IVC assessment Dynamic assessment of fluid responsiveness with passive leg raise or fluid challenge

33 CMS and Coding CMS has been tracking sepsis data since October 2015 Difficulty in tracking data based on death certificates and administrative claims 11 Greater reporting through administrative claims versus death certificates Sepsis may be excluded entirely on certain death certificates Neither CMS or ICD-10 has adopted Sepsis-3 terminology (yet) 7,10 Recommended ICD-10 codes for sepsis: R65.20, septic shock R65.21 Other ICD-10: A41 other septicemia (with multiple subtypes based on organism) Sepsis=severe sepsis=sepsis-induced hypo-perfusion (too many terms)

34 Key Points on Sepsis Updates Infection Broad spectrum antibiotics within one hour after sepsis recognition (strong) Source control as soon as practical (best practice statement) Daily de-escalation of antibiotics (best practice) Resuscitation 30mL/kg crystalloid fluid bolus within 3 hours (strong) with subsequent fluids based on reassessment (best practice), using dynamic variables to assess response (weak) Target MAP 65 mmhg if requiring vasopressors, norepinephrine is first choice (strong) Ventilation in patients with sepsis-related ARDS Tidal volume 6mL/kg PBW, with plateau pressure of 30 cm H 2 O (strong) Formal improvement programs: sepsis screening programs in hospitals (best practice) 1,12

35 Future Guidelines from Surviving Sepsis Campaign Updated Sepsis bundles (2017) SSC Pediatric Guidelines-in the next 2 years SSC Ventilation in ARDS (2017) Sepsis in Resource Limited Nations (ongoing) 1,12

36 References 1. De Backer D, Dorman T. Surviving Sepsis guidelines: A continuous move toward better care of patients with sepsis. JAMA. doi: /jama Singer M, Deutschman CS, Seymour CW, et al. The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA. 2016; 315(8): Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonell M, Ferrer R, Kumar A, et al. Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: Critical Care Med. doi: /ccm Surviving Sepsis Campaign guidelines updated. (2017, January 25). Retrieved from 5. Prognostic value of sepsis criteria compared in the ED and ICU. (2017, January 25). Retrieved from 6. Antonelli M, DeBacker D, Dorman T, Kleinpell R et al. Surviving Sepsis Campaign responds to Sepsis , March Slesinger TL and Dubensky L. Sepsis-3, a new definition. Solutions, or new problems? (2016, July). Retrieved from 8. Freund Y, Lemachatti N, and Krastinova E. Prognostic accuracy of Sepsis-3 criteria for in-hospital mortality among patients with suspected infection presenting to the Emergency Department. JAMA. 2017; 317(3): Raith EP, Udy AA and Bailey M. Prognostic accuracy of the SOFA score, SIRS criteria, and qsofa score for in-hospital mortality among adults with suspected infection admitted to the Intensive Care Unit. JAMA. 2017;317(3): Gesensway D. The clock is ticking: are you struggling to meet the new sepsis measure? Today s Hospitalist Dec Epstein L, Dantes R, Magill S, and Fiore A. Varying estimates of sepsis mortality using death certificates and administrative codes-united States, MMWR Morb Mortal Wkly Rep. 2016;65: Howell MD and Davis AM. Management of sepsis and septic shock. JAMA. doi:10:1001/jama

37 THANK YOU!