Central Line Associated Blood Stream Infection (CLABSI) William Parker, PharmD, BCPS, CGP, CPh

Transcription

1 Central Line Associated Blood Stream Infection (CLABSI) William Parker, PharmD, BCPS, CGP, CPh

2 Learning Objectives for Pharmacists Define Central Line Associated Blood Stream Infections (CLABSIs) and differentiate between the definition of Catheter Related Blood Stream Infections (CRBSIs) Classify different types of central lines Describe appropriate utilization of the various types of central lines Analyze appropriate treatment strategies for CLABSIs and discuss their role in an acute care setting Determine optimal treatment strategies for CLABSIs when given a patient case

3 Learning Objectives for Pharmacy Technicians Define Central Line Associated Blood Stream Infections (CLABSIs) Discuss the various risk factors of CLABSIs Demonstrate appropriate aseptic technique Distinguish the various BUD s associated with low, medium and high risk compounds and elaborate on the importance of utilizing compounded sterile products within this timeframe Assess whether aseptic technique and USP797 guidelines were followed when given a patient case

4 Patient Case #1 RL is a 71yo WM who was admitted to the Intensive Care Unit of an acute care facility with abdominal pain, diarrhea, steatorrhea, weight loss, fatigue and dehydration. RL was diagnosed with short bowel syndrome secondary to a recent hospital stay where approximately 2/3 of the small bowel was removed due to an exacerbation of Crohn s Disease. RL s past medical history includes Type I DM and Crohn s disease. A long term Central Venous Catheter was placed and RL was started on therapy with Total Parenteral Nutrition. RL was on day 8 of therapy with TPN when he developed fever, tachycardia and hypotension. Subsequently, the catheter tip was cultured in addition to a peripheral blood culture. On day 2 MRSA is growing from both the catheter and peripheral blood culture and RL is given a definitive diagnosis of a CLABSI. Which of the following is the BEST way to treat this Central Line Associated Blood Stream Infection? A. Keep the catheter plus 2 weeks therapy with Cefazolin 2gm q8h IV B. Remove the catheter plus 2 weeks of antibiotic therapy with Vancomycin C. Keep the catheter plus 6 weeks therapy with Cefazolin 2gm q8h IV D. Remove the catheter plus 4 weeks of antibiotic therapy with Vancomycin

5 Patient Case #2 JC is a 28yo Pharmacy Technician who is working full time in an Acute Care Hospital. A label prints from the IV label printer and reads Clinimix 5/ mL with the following ingredients:, Sodium Chloride 80mEq Potassium Chloride 60mEq, Calcium Gluconate 1gm, Magnesium Sulfate 8.12 meq, Multivitamins 10mL, Trace Elements 1mL. JC proceeds to the Anteroom (ISO 8) where he brings the Clinimix bag and all other ingredients into the Anteroom, making sure not to cross the line of demarcation. He dons his bouffant, then shoe covers and then his mask. Then he washes his hands up to the forearms, dons a sterile gown and then puts on standard gloves. Sterile isopropyl alcohol is then used to disinfect the gloved hands. Afterwards, sterile isopropyl alcohol and sterile lint free cloths are used to wipe clean all of the medications before transportation into the Clean Room (ISO 7). After completion of the compound JC assigns a Beyond Use Date of 48 hours to the compound. Which statement below BEST describes how JC s performance and compliance with USP797 could be improved? A. Wipe down the medications after bringing them into the ISO 7 environment AND assigning a BUD of 30 hours B. Donning his shoe covers before his bouffant and assigning a BUD of 7 days C. Wipe down the medications after bringing them into the ISO 7 environment AND assigning a BUD of 24 hours D. Donning his shoe covers before his bouffant and assigning a BUD of 24 hours

6 Definitions Catheter Related Blood Stream Infection (CRBSI) Blood Stream Infection caused by an intravascular catheter vs Central Line Associated Blood Stream Infection (CLABSI) Blood Stream Infection caused by a central intravascular catheter

7 What is a central line?

8 Intravascular Devices 1 Type Peripheral venous catheter Peripheral arterial catheter Midline catheter Short-term CVC Pulmonary artery catheter Pressure-monitoring system Peripherally inserted central catheter Long-term CVC Totally implantable device Comment Usually inserted into the veins of the forearm or the hand; the most commonly used short-term intravascular device For short-term use; commonly used to monitor hemodynamic status and to determine blood gas levels of critically ill patients; risk of bloodstream infection may approach that of CVCs Peripheral catheter (size, cm) is inserted via the antecubital fossa into the proximal basilic or cephalic veins, but it does not enter central veins; it is associated with lower rates of infection, compared with CVCs Most commonly used CVC; accounts for the majority of all catheterrelated bloodstream infections Inserted through a teflon introducer and typically remains in place for an average duration of only 3 days Used in conjunction with arterial catheter; associated with both epidemic and endemic nosocomial bloodstream infections Provides an alternative to subclavian or jugular vein catheterization; is inserted via the peripheral vein into the superior vena cava, usually by way of cephalic and basilar veins; similar risk of infection as CVCs in patients hospitalized in intensive care units Surgically implanted CVC (e.g., Hickman, Broviac, or Groshong catheter) with the tunneled portion exiting the skin and a dacron cuff just inside the exit site; used to provide vascular access to patients who require prolonged chemotherapy, home-infusion therapy, or hemodialysis A subcutaneous port or reservoir with self-sealing septum is tunneled beneath the skin and is accessed by a needle through intact skin; associated with low rates of infection

9 Definitions Catheter Related Blood Stream Infection (CRBSI) 1 Bacteremia or fungemia in a patient who has an intravascular device and >1 positive blood culture result obtained from the peripheral vein with clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for bloodstream infection (with the exception of the catheter) Additionally, one of the following MUST be present A positive result of semiquantitative (>15 cfu per catheter segment) Quantitative (>10 2 cfu per catheter segment) catheter culture, whereby the same organism (species) is isolated from a catheter segment and a peripheral blood culture Simultaneous quantitative cultures of blood with a ratio of >3:1 cfu/ml of blood (catheter vs. peripheral blood) Differential time to positivity (growth in a culture of blood obtained through a catheter hub is detected by an automated blood culture system at least 2 h earlier than a culture of simultaneously drawn peripheral blood of equal volume)

10 Definitions Catheter Related Blood Stream Infection (CRBSI) 2 Clinical Definition Requires specific laboratory testing that more thoroughly identifies the catheter as the source of the BSI Not used for surveillance purposes due to the complicated definition and diagnosis Due to the clinical needs of the patient, the catheter is not always pulled Microbiological methods required to meet the definition are often not readily available More strict definition vs Central Line Associated Blood Stream Infection (CLABSI)

11 Definitions Central Line Associated Blood Stream Infection (CLABSI) 2 A laboratory-confirmed bloodstream infection (LCBI) where central line (CL) or umbilical catheter (UC) was in place for >2 calendar days on the date of event, with day of device placement being Day 1 Additionally, the line was also in place on the date of event or the day before A Central Line is defined as an intravascular catheter that terminates at or close to the heart or in one of the great vessels which is used for infusion, withdrawal of blood, or hemodynamic monitoring Great Vessels 3 : Aorta, Pulmonary artery, Superior vena cava, Inferior vena cava, Brachiocephalic veins, Internal jugular veins, Subclavian veins, External iliac veins, Common iliac veins, Femoral veins, umbilical artery/vein

12 Definitions Central Line Associated Blood Stream Infection (CLABSI) 2 Surveillance Definition Established by the CDC/NHSN for surveillance purposes in an effort to improve patient safety Useful due to a more simplified definition and diagnosis in order to aid in reporting, tracking and trending events More lenient definition vs Catheter Related Blood Stream Infection (CRBSI)

13 Determining CLABSIs Example #1 Patient has a central line inserted on June 1. On June 3, the central line is still in place and the patient s blood is collected for culture. The culture is positive for S. aureus. This IS a CLABSI because the central line was in place for >2 calendar days (June 1, 2, and 3), and still in place, on the date of event (June 3) 3

14 Determining CLABSIs Example #2 Patient has a central line inserted on June 1. On June 3, the central line is removed and on June 4 the patient s blood is collected for culture. The culture is positive for S. aureus. This IS a CLABSI because the central line was in place for >2 calendar days (June 1, 2, and 3), and was in place the day before the date of event (June 4) 3

15 Determining CLABSIs Example #3 Patient has a central line inserted on June 1. On June 3, the central line is removed. On June 5 patient spikes a fever of 38.3 C and the patient s blood is collected for culture. The culture is positive for S. aureus. This meets CRBSI criteria but it is NOT a CLABSI because the Date of Event (June 5) did not occur on the day the central line was discontinued (June 3) nor the next day (June 4) 3

16 Epidemiology Over 150 million intravascular devices are purchased each year 1 Over 80,000 CVC related blood stream infections per year 1 Considered a hospital acquired infection (HAI) 2 CRBSIs independently increase hospital length of stay and hospital cost (7k 29k per episode) 4

17 Independent Risk Factors 1,2 Intravascular Catheterization Central Lines carry a higher risk Duration of catheterization Density of skin flora at catheterization site Total Parenteral Nutrition Prolonged use of broad-spectrum antibiotics Hematologic malignancy Receipt of bone marrow or solid-organ transplant Femoral catheterization Colonization due to Candida species at multiple sites

18 Pathophysiology 1,5 Short-term Skin Flora move along the external surface of the catheter and proceed to colonize the tip and then infect the blood stream causing a CLABSIs Long-term Catheter lumen is the major source of microbes causing CLABSIs

19 Goals of Therapy Decrease Morbidity Decrease Mortality Decrease healthcare costs associated with CRBSI/CLABSI

20 General Treatment Approach Adapted from fig. 1 CID 2009:49:1-45

21 Catheter Management Options Remove Catheter 1 Replace Catheter Previous catheter is removed and replaced with a new catheter in new location In most cases, catheter removal is considered an essential component Guide-Wire exchange Previous catheter is removed and replaced with new catheter in same location Used when infection is only suspected and other IV sites are limited Minimizes mechanical complications Salvage Catheter 1 Antibiotic Lock Therapy Supra-therapeutic concentration of antibiotic that dwells in catheter lumen when not in use Acceptable uses Long term catheters that cannot be removed No systemic complications( hemodynamic instability, tissue hypoperfusion, septic thrombosis) Signs of local infections Unacceptable uses Complicated infections S. aureus or fungal infections If repeat cultures remain positive after 72 hours, the catheter should be replaced

22 Empiric Therapy 1 Gram Positives Cover MRSA in ALL patients 1 st line agent: Vancomycin 2 nd line agent: Daptomycin Consider if MICs > 2 mcg/ml Gram Negatives Cover only in patients at risk Critically ill, sepsis, neutropenic, femoral catheter Consider double coverage if critically ill or colonization with MDRO based on local antibiogram Candida Cover only in patients at risk Sepsis with TPN, bone marrow or solid organ transplantation, hematologic malignancy, or prolonged use of broad spectrum antibiotics 1 st line agent: Echinocandin 2 nd line agent: Fluconazole 1 st Line if No azole exposure in the previous 3 months and Health care settings where the risk of Candida krusei/glabrata infection is very low

23 Response to Blood Cultures Adapted from fig. 1 CID 2009:49:1-45

24 Coagulase-Negative Staphylococci (CoNS) 1 Short term CVC: The patient may be observed without systemic antibiotics if catheter is removed and additional blood cultures are obtained after catheter removal OR remove catheter and treat with systemic antibiotics for 5-7 days OR May retain catheter and treat with systemic antibiotics and antibiotics lock therapy for days Long term CVC: Retain catheter and treat with systemic antibiotics and antibiotics lock therapy for day OR May remove catheter if there is clinical deterioration or persisting/relapsing bacteremia and treat as complicated infection **Staphylococcus lugdunensis should be managed based on S. aureus recommendations

25 Staphylococcus aureus 1 Short term CVC: Remove catheter and treat with systemic antibiotics for at least 14 days Long term CVC: Remove catheter and treat with systemic antibiotics for 4-6 weeks OR May treat with at least 14 days in low risk patients Low risk patients must meet ALL of the following: Non diabetic, not immunosuppressed, no prosthetic intravascular device, no evidence of complicated infections, catheter is removed, fever and bacteremia resolve within 72h after appropriate antibiotics Requires a TEE 5-7 days after bacteremia onset to rule out endocarditis

26 Enterococcus 1 Short term CVC: Remove catheter and treat with systemic antibiotics for 7-14 days Long term CVC: Retain catheter and treat with systemic antibiotics and antibiotics lock therapy for 7-14 days OR May remove catheter if there is clinical deterioration or persisting/relapsing bacteremia and treat as complicated infection

27 Gram Negative bacilli 1 Short term CVC: Remove catheter and treat with systemic antibiotics for 7-14 days Long term CVC: Remove catheter and treat with systemic antibiotics for 7-14 days OR May retain catheter and treat with systemic antibiotics and antibiotics lock therapy for days If no response, remove catheter and rule out endocarditis and thrombophlebitis

28 Candida spp. 1 Short term CVC: Remove catheter and treat with antifungal for 14 days after 1 st negative blood culture Long term CVC: Remove catheter and treat with antifungal for 14 days after 1 st negative blood culture

29 Complicated Infections 1 Infections associated with: Suppurative thrombophlebitis Endocarditis Osteomyelitis Possible septic metastases Hematogenous seeding Treatment Remove catheter and treat with systemic antibiotics for 4-6 weeks OR Remove catheter and treat osteomyelitis with systemic antibiotics for 6-8 weeks

30 Systemic Pharmacotherapy Pathogen Drug of Choice Alternative Tx CoNS Oxacillin 2g IV q4h Vancomycin S. aureus Oxacillin 2g IV q4h Cefazolin 2g IV q8h or Vancomycin MRSA Vancomycin Daptomycin 8-10 mg/kg IV q24h Enterococcus faecalis Ampicillin 2g IV q4h Vancomycin Enterococcus faecium Linezolid 600 mg IV q12h Daptomycin 8-12 mg/kg IV q24h +/- Gentamicin for critically ill patients Gram (-) bacilli Based on sensitivities Candida Echinocandin Or Fluconazole Echinocandin Or Fluconazole

31 USP797 Aseptic Technique 7 Before entering the compounding area: Presents in a clean appropriate attire and manner Wears no cosmetics or jewelry (watches, rings, earrings, etc. piercing jewelry included) upon entry into ante area Has no evidence of rash, fever, active respiratory infection, fever, sunburn, conjunctivitis, weeping sores Brings no food or drinks into or stored in the ante-areas or buffer areas Is aware of the line of demarcation separating clean and dirty sides and observes required activities (for LAFW)

32 USP797 Aseptic Technique 7 Prior to compounding (Ante Room): Dons shoe covers or designated clean-area shoes one at a time, placing the covered or designated shoe on clean side of the line of demarcation, as appropriate Dons beard cover if necessary Dons head cover assuring that all hair is covered Dons face mask to cover bridge of nose down to include chin (for LAFW) Performs hand hygiene procedure by wetting hands and forearms and washing using soap and warm water for at least 30 seconds in ante area Dries hands and forearms using lint-free towel or hand dryer in ante area Selects the appropriate sized gown examining for any holes, tears, or other defects in ante area Dons gown and ensures full closure in ante area Disinfects hands again using a waterless alcohol-based surgical hand scrub with persistent activity and allows hands to dry thoroughly before donning sterile gloves

33 USP797 Aseptic Technique 7 Immediately prior to compounding (Clean room): Dons appropriate sized sterile gloves ensuring that there is a tight fit with no excess glove material at the fingertips (in Buffer area for LAFW) Sterile Gloves are used for compounding For CAI s, sterile gloves are the gloves in contact with the products Examines gloves ensuring that there are no defects, holes, or tears While engaging in sterile compounding activities, routinely disinfects sterile gloves with sterile 70% IPA prior to work in the direct compounding area (DCA) and after touching items or surfaces that may contaminate gloves

34 USP797 Aseptic Technique 7 Compounding: Clean ISO Class 5 device surfaces with an appropriate agent(s) Disinfectant is allowed to dry prior to using for compounding Cleaning materials are made of non-shedding material and dedicated for use in the compounding area Clean components/vials with an appropriate agent prior to placing into ISO Class 5 work area Introduces only essential materials in a proper arrangement in the ISO Class 5 work area Does not interrupt, impede, or divert flow of first-air to critical sites

35 USP797 Aseptic Technique 7 Compounding continued: Ensures IV bags with overwrap, syringes, needles, and tubing remain in their individual packaging and are only opened in ISO Class 5 work area Performs manipulations only in the appropriate DCA of the ISO Class 5 device Does not expose critical sites to contact contamination or worse than ISO Class 5 air Disinfects stoppers, injection ports, and ampule necks by wiping with STERILE 70% IPA and allows sufficient time to dry Affixes needles to syringes without contact contamination Disinfects sterile gloves routinely by wiping with sterile 70% IPA during prolonged compounding manipulations

36 USP797 Beyond Use Dating7

37 Patient Case #1 RL is a 71yo WM who was admitted to the Intensive Care Unit of an acute care facility with abdominal pain, diarrhea, steatorrhea, weight loss, fatigue and dehydration. RL was diagnosed with short bowel syndrome secondary to a recent hospital stay where approximately 2/3 of the small bowel was removed due to an exacerbation of Crohn s Disease. RL s past medical history includes Type I DM and Crohn s disease. A long term Central Venous Catheter was placed and RL was started on therapy with Total Parenteral Nutrition. RL was on day 8 of therapy with TPN when he developed fever, tachycardia and hypotension. Subsequently, the catheter tip was cultured in addition to a peripheral blood culture. On day 2 MRSA is growing from both the catheter and peripheral blood culture and RL is given a definitive diagnosis of a CLABSI. Which of the following is the BEST way to treat this Central Line Associated Blood Stream Infection? A. Keep the catheter plus 2 weeks therapy with Cefazolin 2gm q8h IV B. Remove the catheter plus 2 weeks of antibiotic therapy with Vancomycin C. Keep the catheter plus 6 weeks therapy with Cefazolin 2gm q8h IV D. Remove the catheter plus 4 weeks of antibiotic therapy with Vancomycin

38 Patient Case #1 RL is a 71yo WM who was admitted to the Intensive Care Unit of an acute care facility with abdominal pain, diarrhea, steatorrhea, weight loss, fatigue and dehydration. RL was diagnosed with short bowel syndrome secondary to a recent hospital stay where approximately 2/3 of the small bowel was removed due to an exacerbation of Crohn s Disease. RL s past medical history includes Type I DM and Crohn s disease. A long term Central Venous Catheter was placed and RL was started on therapy with Total Parenteral Nutrition. RL was on day 8 of therapy with TPN when he developed fever, tachycardia and hypotension. Subsequently, the catheter tip was cultured in addition to a peripheral blood culture. On day 2 MRSA is growing from both the catheter and peripheral blood culture and RL is given a definitive diagnosis of a CLABSI. Which of the following is the BEST way to treat this Central Line Associated Blood Stream Infection? A. Keep the catheter plus 2 weeks therapy with Cefazolin 2gm q8h IV B. Remove the catheter plus 2 weeks of antibiotic therapy with Vancomycin C. Keep the catheter plus 6 weeks therapy with Cefazolin 2gm q8h IV D. Remove the catheter plus 4 weeks of antibiotic therapy with Vancomycin

39 Patient Case #2 JC is a 28yo Pharmacy Technician who is working full time in an Acute Care Hospital. A label prints from the IV label printer and reads Clinimix 5/ mL with the following ingredients:, Sodium Chloride 80mEq Potassium Chloride 60mEq, Calcium Gluconate 1gm, Magnesium Sulfate 8.12 meq, Multivitamins 10mL, Trace Elements 1mL. JC proceeds to the Anteroom (ISO 8) where he brings the Clinimix bag and all other ingredients into the Anteroom, making sure not to cross the line of demarcation. He dons his bouffant, then shoe covers and then his mask. Then he washes his hands up to the forearms, dons a sterile gown and then puts on standard gloves. Sterile isopropyl alcohol is then used to disinfect the gloved hands. Afterwards, sterile isopropyl alcohol and sterile lint free cloths are used to wipe clean all of the medications before transportation into the Clean Room (ISO 7). After completion of the compound JC assigns a Beyond Use Date of 48 hours to the compound. Which statement below BEST describes how JC s performance and compliance with USP797 could be improved? A. Wipe down the medications after bringing them into the ISO 7 environment AND assigning a BUD of 30 hours B. Donning his shoe covers before his bouffant and assigning a BUD of 7 days C. Wipe down the medications after bringing them into the ISO 7 environment AND assigning a BUD of 24 hours D. Donning his shoe covers before his bouffant and assigning a BUD of 24 hours

40 Patient Case #2 JC is a 28yo Pharmacy Technician who is working full time in an Acute Care Hospital. A label prints from the IV label printer and reads Clinimix 5/ mL with the following ingredients:, Sodium Chloride 80mEq Potassium Chloride 60mEq, Calcium Gluconate 1gm, Magnesium Sulfate 8.12 meq, Multivitamins 10mL, Trace Elements 1mL. JC proceeds to the Anteroom (ISO 8) where he brings the Clinimix bag and all other ingredients into the Anteroom, making sure not to cross the line of demarcation. He dons his bouffant, then shoe covers and then his mask. Then he washes his hands up to the forearms, dons a sterile gown and then puts on standard gloves. Sterile isopropyl alcohol is then used to disinfect the gloved hands. Afterwards, sterile isopropyl alcohol and sterile lint free cloths are used to wipe clean all of the medications before transportation into the Clean Room (ISO 7). After completion of the compound JC assigns a Beyond Use Date of 48 hours to the compound. Which statement below BEST describes how JC s performance and compliance with USP797 could be improved? A. Wipe down the medications after bringing them into the ISO 7 environment AND assigning a BUD of 30 hours B. Donning his shoe covers before his bouffant and assigning a BUD of 7 days C. Wipe down the medications after bringing them into the ISO 7 environment AND assigning a BUD of 24 hours D. Donning his shoe covers before his bouffant and assigning a BUD of 24 hours

41 References 1. Clinical Practice Guidelines for the Diagnosis and Management of Intravascular Catheter- Related Infection: 2009 Update by the Infectious Diseases. Society of America. Leonard A. Mermel, et al. 2. CDC/NHSN Guidelines for the prevention of intravascular catheter related infections Naomi P. O'Grady, M.D.1, et al. 3. CDC/NHSN Bloodstream Infection Event (Central Line-Associated Bloodstream Infection and Non-central line-associated Bloodstream Infection). January Scott, Douglas II (2008). The Direct Medical Costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention. March Raad I, Costerton W, Sabharwal U, Sacilowski M, Anaissie E, Bodey, GP. Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and duration of placement. J Infect Dis 1993; 168: Pharmaceutical compounding sterile preparations (general information chapter 797). In: The United States Pharmacopeia, 36th rev., and the National Formulary, 31 ed. Rockville, MD: The United States Pharmacopeial Convention; 2013: