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Sepsis in the Rural Setting: Early Recognition and Management Mike Broyles, BSPharm, PD, PharmD Director of Pharmacy and Laboratory Services Five Rivers.

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Presentation on theme: "Sepsis in the Rural Setting: Early Recognition and Management Mike Broyles, BSPharm, PD, PharmD Director of Pharmacy and Laboratory Services Five Rivers."— Presentation transcript:

1 Sepsis in the Rural Setting: Early Recognition and Management Mike Broyles, BSPharm, PD, PharmD Director of Pharmacy and Laboratory Services Five Rivers Medical Center Pocahontas, AR

2 No Disclosures

3 Objectives Understand the definitions and differing clinical presentations of SIRS, Sepsis, Severe Sepsis and Septic shock as defined by SCCM/ACCP Discuss the role of biomarkers, clinical presentation, and other laboratory tests used in the evaluation of patients with suspected Sepsis Recognize how procalcitonin, other biomarkers, and clinical exam can assist in early recognition, risk stratification, and management of patients with suspected and confirmed Sepsis

4 Outline Seriousness of sepsis Difficulties with the diagnosis of sepsis Procalcitonin (PCT) Biomarker Kinetics Comparison to other biomarkers Application of PCT into sepsis management

5 Strikes more than 750,000 people each year in the United States Mortality remains greater than 30% (1 person every 2.5 minutes) Mortality rate has not improved in the last 20 years Newborn, pediatric, adults, aged Morbidity Surgical sepsis rate is increasing Clinical diagnosis remains challenging Severe sepsis is costly and life- threatening

6 Determinants of mortality from sepsis Early intervention is critical Appropriate antibiotic therapy within one hour of hypotension Resuscitation / re-establish perfusion within six hours

7 Duration of hypotension before initiation of appropriate ABX therapy is the critical determinant of survival in septic shock

8 Why do we struggle with the diagnosis of sepsis?

9 Relationship of SIRS, Sepsis, and Infection

10 SIRS Criteria: Two or more of the following Temperature > 100.4F (38C) or < 96.8F (36C) Heart rate > 90 beats/minute Respiratory rate > 20 breaths/minute or PaCO 2 < 32 mm Hg WBC o > 12,000/mm 3 o < 4000/mm 3 o > 10% immature (band) forms

11 Tachycardia – 718 possibilities Tachypnea - 371 possibilities Increased/Decreased Temperature – 1380 possibilities Increased/Decreased WBC – 350 possibilities Making the Diagnosis www.diagnosispro.com 541 possible diagnoses with 2 or more of the criteria

12 Sepsis: ACCP/SCCM Definitions Sepsis is SIRS plus a known or suspected infection. Severe Sepsis is sepsis associated with organ dysfunction, hypoperfusion, or hypotension. Septic Shock is sepsis-induced hypotension despite adequate fluid resuscitation along with the presence of perfusion abnormalities. May include Lactic acidosis Oliguria An Acute alteration in mental status Others… Bone RC, et al. Chest 1992 Jun;101(6):1644-55. SIRSSepsis Severe Sepsis Septic Shock

13 100% 0% Pretest situation: only clinical assessment is available Assessment of individual features and addition of PCT Post-test situation: Individually adjusted risk assessment Probability of a Sepsis Diagnosis 40% PCT 2.0 PCT 0.3 > 90% < 10% Michael Meisner; Procalcitonin-Biochemistry and Clinical Diagnosis

14 What is Procalcitonin and its role in sepsis management?

15 Procalcitonin PCT is an immunologically active protein PCT is induced in systemic inflammatory reactions Bacterial infections induce PCT PCT induction is generally in direction proportion to the bacterial insult to the body Viral infections, autoimmune diseases, transplant rejections, and allergic reactions generally do not induce PCT PCT is therefore an “indirect marker” of a bacterial infection: PCT a measurement of the body’s inflammatory response to the bacteria

16 Calcitonin: Source of production in healthy people Müller B. et al., JCEM 2001 In relevant bacterial infection, PCT is produced and released into circulation from the entire body Highly specific induction – Produced all tissue Healthy Sepsis PCT: Source of Production in Septic Patients

17 PCT Kinetics Rapid kinetics: detectable 3 hours after infection has begun, with a peak after 12 to 24 hours Peak values up to 1000 ng/ml Half-life: ~ to 24 hours 17 Brunkhort FM et al., Intens. Care Med (1998) 24: 888-892 Time (Hours) Plasma Concentration 1 2612244872 PCT

18 In critically ill patients, PCT levels elevate in correlation to the severity of bacterial infection Integrating PCT in sepsis management can lead to improved patient outcomes PCT values correlate directly with severity of bacterial load

19 PCT as a response to bacterial challenge Elevated or rising PCT values Systemic response to bacterial infection o Progressing infection o Immune system is overwhelmed Risk of significant disease progression Low PCT values in presence of clinical presentation Self-limiting infection Non-bacterial etiology Early phase of infection

20 Primary inflammation syndrome following trauma: multiple trauma, extensive burns, major surgery (abdominal and transplant) Severe pancreatitis or severe liver damage (1) Prolonged circulatory failure: IE severe multiple organ dysfunction syndrome (MODS) (1.4) Medullary C-cell cancers of the thyroid, pulmonary small- cell carcinoma and bronchial carcinoma Newborn < 48hr - increased PCT values (physiological peak) Procalcitonin release in the absence of infection

21 Newborns less than 48 hours PCT measurements Age (hours) PCT (ng/ml) 0 – 6 hours≤ 2 6 – 12 hours≤ 8 12 – 18 hours≤15 18 – 30 hours≤ 21 30 – 36 hours≤ 15 36 – 42 hours≤ 8 42 – 48 hours≤ 2 Chiesa et al., Council & Institute of Ped (1998) 45: 89-97

22 C-Reactive Protein (CRP) Acute Phase Reactant synthesized by the liver Secretion triggered by cytokine (IL-6, IL-1, TNF-α) Produced in response to acute & chronic inflammation Bacterial, Viral, Fungal Rheumatic Inflammatory diseases Malignancy Tissue Injury, Necrosis Steroid Treatment Liver Failure Obesity Advantages: o Rises in 4 to 6 hours Disadvantages: o Non-specific o No correlation to SOFA Scores, o Slow Kinetics (peak 36-50h) Vingishi et al., J Clin Invest. 1993 Apr ; 91(4): 1351-7 Pepys et al., J of Clin Invest. 2003g 1807 col 2 para 2, pg 1808 col 1 para 1 Standage et al., Expert Rev Anti Infect Ther. 2011 Jan 9(1): 71-79

23 Interleukin-6 (IL-6 ) Pro-inflammatory cytokine (messenger protein) Blood, monocytes, and endothelial cells Advantage o Quick rise – one hour o Decreases rapidly Disadvantage o Any inflammatory process can increase IL-6 o Affected in immune-compromised patients o Sample must be cooled and spun immediately o Containers must be free of endotoxins since IL-6 can be formed by decomposed leukocytes in the blood sample Vingishi et al., J Clin Invest. 1993 Apr ; 91(4): 1351-7 Pepys et al., J of Clin Invest. 2003g 1807 col 2 para 2, pg 1808 col 1 para 1 Standage et al., Expert Rev Anti Infect Ther. 2011 Jan 9(1): 71-79

24 Lactate Lactate (lactic acid) is produced due to inadequate tissue perfusion – a defining parameter of late sepsis. Advantage Rapid turn-around Readily available Reliable marker of perfusion and prognosis Disadvantage Late elevation in course of sepsis Non-specific Reduction of lactate is advocated as a target for therapeutic interventions (2C) Blomkalns AL www.emcreg.org 2007 Poeze M, et al. Crit Care Med 2005 Nov;33(11):2494-500 Muller B, et al. Crit Care Med 2000 Apr;28(4):977-83

25 Diagnostic accuracy of PCT compared to other biomarkers used in sepsis

26 BP142/8290/5898/60 “BE”: UTI Case: Lactate Specificity ABXCeftriaxoneZosyn-TobramycinVancomycin

27 Case Presentations Application of PCT use for Sepsis and Antibiotic Management

28 HW CC/Hx/Presentation 73 Y/O female CC: dysuria, mental status changes, fever, nausea/vomiting S/P laparoscopic cholecystectomy: 4 days post procedural complication r/o Temp 103.4 RR 19 BP 86/52 HR 95 WBC 28.4 w/4 bands SrCr 1.6 w/ BUN 38 Mini-cath UA Nitrite positive 4+ bacteria Medications Amlodipine 10mg daily Benazepril 20mg daily Propranolol LA 160mg daily HCTZ 25mg daily Aspirin 81 mg daily Furosemide 40mg prn daily for leg edema Oxybutynin 5mg bid Alprazolam 0.5mg tid Dicyclomine 10mg prn tid for irritable bowel Meloxicam 15mg daily Zolpidem 5mg hs

29 HW ED Treatment Plan: Dx of Sepsis due to UTI Admit to ICU Meropenem Tobramycin Cystalloids and dopamine

30 HW Hospitalist orders PCT in ICU after admission PCT 0.25 ng/ml Fluid bolus and continued rehydration DC dopamine DC merpenem DC tobramycin Start piperacillin/tazobactam Moved to Med-Surg Cx: Proteus mirabilis sensitive to 1 st generation cephalosporins and resistant to quinolones (day2) Changed to cephalexin

31 HW Clinical Perles Patient met SIRS criteria SIRS criteria complicated by medications? SIRS criteria clouded by volume depletion? Baseline PCT Process to ensure PCT draw Establish a process - Order sets Considerations Assumed sepsis prompting aggressive response ICU admission? Vasopressor?

32 Labs/X-Ray/Plan Temp 99.2 Pulse 80-90 WBC 13.1 SrCr 2.1 PCT 21 Plain Film US: Subcutaneous edema suggesting cellulitis, but no localized collections MRI: Myositis involving vastus lateralis muscle with overlying cellulitis. Most likely etiologies from infection or trauma Surgery consult Antibiotics CC/Hx/Presentation 48 Y/O male Occupation: Lineman CC: Worsening right thigh and knee pain Five scratches on leg, 2 -3 cm in length from thorns/briars Pain is not proportional to visual presentation Started 24 hours ago Complains area is “pulsing” Patient states: “Some swelling in last 18 hours”WR

33 WR ED orders Clindamycin 300 IV once Doxycycline 100 mg IV once Initial Admission orders Clindamycin 300 mg IV every 6 hours Doxycycline 100 mg IV every 12 hours

34 WR Revised admission orders DC Doxycycline Clindamycin 800 mg IV every 8 hours Piperacillin/tazobactam 3.375 grams IV every 6 hours

35 WR

36 WR – MRI Leg

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38 WR Clinical Perles: Continued Procalcitonin escalation despite suspected adequate Abx Clinical presentation mismatch to seriousness of illness A significant elevation in PCT is always a cause for concern Resistant organism Abscess Need for surgical intervention Other source/site of infection

39 ST Medications Glargine insulin 32 units daily Regular insulin Sliding Scale Sitagliptin 100mg daily Lisinopril 20mg bid Furosemide 20mg bid Carvedilol 25mg bid Gabapentin 400mg tid Pregabalin 150mg bid Alprazolam 0.5mg prn tid “Aleve” 440mg prn bid on “most days” Hydrocodone/Acet 5mg/325mg prn q 4h for pain CC/Hx/Presentation 66 Y/O female CC: pain, tenderness, and fever with recurrent cellulitis of left great toe and shin just superior to ankle Second day of recurrent infection that had “resolved” two weeks ago Adult onset insulin dependent diabetic Neuropathy in legs/feet Mild CHF HTN

40 ST clinical course Admission – AM Plain film Scheduled MRI WBC 12.8 PCT 0.6 SrCr 1.8 Piperacillin/Tazobactam Vancomycin

41 ST clinical course Day 1 - AM WBC 14.4 PCT 16 Lactate 2.1 SrCr 1.7 Replace Piperacillin/Tazobactam with Meropenem Day 1 - PM WBC 16.8 PCT 26 Lactate 2.1 Replaced Vancomycin with Linezolid

42 ST clinical course Day 2 - AM WBC 24.8 PCT 77 Lactate 4.4 SrCr 2.4 Worsened hemo-dynamically: increased LVP rate Added Tobramycin 7mg/kg Day 2 - PM PCT 64 Lactate 2.2

43 ST clinical course Day 3 - AM WBC 22.0 PCT 39 Lactate 1.9 Blood Cx: gram stain gram negative rods Day 3 - PM First blood Cx and sensitivity completed Escherichia coli: CRE

44 ST Blood Culture #1

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46 ST Clinical Perles Understanding PCT principles will allow effective monitoring and shorten time to intervene > requires through education efforts Reducing intervention time can preempt more serious disease progression PCT is effective in monitoring and managing antibiotic therapy

47 GM CC/Hx 83 Y/O female Nursing home resident CC: SOB Worsening over 4 days COPD (Gold Stage III) Recent pneumonia hospitalization CHF HTN Fibromyalgia GERD AAA Repair 2 stents in 2012 Spine surgery X4 Presentation Pulse Ox 82% RR 24 Prolonged expiration Rhonchi bilaterally A/P Chest film WBC 3.2 Platelets 99,000 PCT 0.06 Temp 102.4 BP 143/87 Pulse 77 BNP 489

48 GM Medications Ticagrelor 90mg bid Aspirin 81mg daily (was 325mg) Pregabalin 75mg bid Carvedilol 6.25mg bid Atorvastatin 40mg daily Amiodarone 100mg daily Enalapril 20mg bid Mirtazapine 15mg hs Furosemide 40mg daily (doubled last 4 days) Hydrocodone/APAP 10mg qid Duloxetine 60mg daily Ipratropium/Albuterol qid Albuterol prn q 2 hours “Prednisone taper” Assessment/Plan Pneumonia Infiltrates Productive cough Signs of infection/inflammation COPD exacerbation CHF exacerbation Cefepime Vancomycin Methylpresnisolone Furosemide Peripheral smear

49 GM Admission Cefepime 1gm q 8 hours Vancomycin dose adjusted Furosemide 40mg IV q 12 hours Methylprednisolone 60mg IV q 6 hours Day 1 AM All meds same except: DC Furosemide: BP 90/60’s & HR > 110

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52 GM Clinical Perles WBC may be a poor biomarker affected by immune state, diseases, and steroids When LOS permits, use PCT follow up algorithms to stop antibiotic therapy sooner Decrease ABX exposure Selection for resistance Adverse event reduction

53 Keys to Success: Early Recognition and Treatment Process in place to avoid loopholes and achieve consistency Protocol or Order Sets Appropriate biomarkers with clinical presentation o Sensitivity o Specificity Lactate should be used primarily for evaluation of resuscitation efforts Educate staff

54 Five Rivers Medical Center Outcomes Comparison: Control Vs. Procalcitonin Date range 3 years Case Mix: 40% coded to an ID related diagnosis Sepsis related LOS-50% Sepsis related drugs costs-50% ICU admissions due to sepsis-64% Antibiotic exposure – sepsis related-45% GI related ADR’s (all reported)-40% Clostridium difficile infections-54%

55 The most important indications for PCT levels Diagnosis of sepsis, severe sepsis, and septic shock Differential diagnosis of clinically relevant bacterial infections and sepsis Evaluation of the severity of a bacterial infection and systemic inflammatory reactions Monitoring of the course of treatment of patients with sepsis Evaluation of progression and control of antibiotic treatment Summary Michael Meisner; Procalcitonin-Biochemistry and Clinical Diagnosis

56 Questions


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