Download Central Line Associated Blood Stream Infection (CLABSI)

Central Line Associated Blood Stream
Infection (CLABSI)
William Parker, PharmD, BCPS, CGP, CPh
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
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
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.
B.
C.
D.
Keep the catheter plus 2 weeks therapy with Cefazolin 2gm q8h IV
Remove the catheter plus 2 weeks of antibiotic therapy with Vancomycin
Keep the catheter plus 6 weeks therapy with Cefazolin 2gm q8h IV
Remove the catheter plus 4 weeks of antibiotic therapy with Vancomycin
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 5/20 - 2000mL 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.
B.
C.
D.
Wipe down the medications after bringing them into the ISO 7 environment AND
assigning a BUD of 30 hours
Donning his shoe covers before his bouffant and assigning a BUD of 7 days
Wipe down the medications after bringing them into the ISO 7 environment AND
assigning a BUD of 24 hours
Donning his shoe covers before his bouffant and assigning a BUD of 24 hours
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
What is a central line?
Intravascular Devices1
Type
Comment
Peripheral venous catheter
Usually inserted into the veins of the forearm or the hand; the
most commonly used short-term intravascular device
Peripheral arterial catheter
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
Midline catheter
Peripheral catheter (size, 7.6–20.3 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
Short-term CVC
Most commonly used CVC; accounts for the majority of all catheterrelated bloodstream infections
Pulmonary artery catheter
Pressure-monitoring system
Peripherally inserted central catheter
Long-term CVC
Totally implantable device
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
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 (>102 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)
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)
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 Vessels3:
– 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
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)
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
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
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
Epidemiology
• Over 150 million intravascular devices are
purchased each year1
• Over 80,000 CVC related blood stream
infections per year1
• Considered a hospital acquired infection
(HAI)2
• CRBSIs independently increase hospital length
of stay and hospital cost (7k – 29k per
episode)4
Independent Risk Factors1,2
• 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
Pathophysiology1,5
• 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
Goals of Therapy
• Decrease Morbidity
• Decrease Mortality
• Decrease healthcare costs associated with
CRBSI/CLABSI
General Treatment Approach
Adapted from fig. 1 CID 2009:49:1-45
Catheter Management Options
• Remove Catheter1
– 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 Catheter1
– 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
Empiric Therapy1
•
Gram Positives
– Cover MRSA in ALL patients
•
•
•
1st line agent: Vancomycin
2nd 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
– 1st line agent: Echinocandin
– 2nd line agent: Fluconazole
•
1st 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
Response to Blood Cultures
Adapted from fig. 1 CID 2009:49:1-45
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 10-14 days
• Long term CVC:
– Retain catheter and treat with systemic antibiotics and antibiotics lock therapy
for 10-14 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
Staphylococcus aureus1
• 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
Enterococcus1
• 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
Gram Negative bacilli1
• 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 10-14 days
• If no response, remove catheter and rule out endocarditis
and thrombophlebitis
Candida spp.1
• Short term CVC:
– Remove catheter and treat with antifungal for 14
days after 1st negative blood culture
• Long term CVC:
– Remove catheter and treat with antifungal for 14
days after 1st negative blood culture
Complicated Infections1
• 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
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
USP797 Aseptic Technique7
• 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)
USP797 Aseptic Technique7
• 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
USP797 Aseptic Technique7
• 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
USP797 Aseptic Technique7
• 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
USP797 Aseptic Technique7
• 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
USP797 Beyond Use Dating7
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.
B.
C.
D.
Keep the catheter plus 2 weeks therapy with Cefazolin 2gm q8h IV
Remove the catheter plus 2 weeks of antibiotic therapy with Vancomycin
Keep the catheter plus 6 weeks therapy with Cefazolin 2gm q8h IV
Remove the catheter plus 4 weeks of antibiotic therapy with Vancomycin
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.
B.
C.
D.
Keep the catheter plus 2 weeks therapy with Cefazolin 2gm q8h IV
Remove the catheter plus 2 weeks of antibiotic therapy with Vancomycin
Keep the catheter plus 6 weeks therapy with Cefazolin 2gm q8h IV
Remove the catheter plus 4 weeks of antibiotic therapy with Vancomycin
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 5/20 - 2000mL 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.
B.
C.
D.
Wipe down the medications after bringing them into the ISO 7 environment AND
assigning a BUD of 30 hours
Donning his shoe covers before his bouffant and assigning a BUD of 7 days
Wipe down the medications after bringing them into the ISO 7 environment AND
assigning a BUD of 24 hours
Donning his shoe covers before his bouffant and assigning a BUD of 24 hours
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 5/20 - 2000mL 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.
B.
C.
D.
Wipe down the medications after bringing them into the ISO 7 environment AND
assigning a BUD of 30 hours
Donning his shoe covers before his bouffant and assigning a BUD of 7 days
Wipe down the medications after bringing them into the ISO 7 environment AND
assigning a BUD of 24 hours
Donning his shoe covers before his bouffant and assigning a BUD of 24 hours
References
1.
2.
3.
4.
5.
6.
Clinical Practice Guidelines for the Diagnosis and Management of Intravascular CatheterRelated Infection: 2009 Update by the Infectious Diseases. Society of America. Leonard A.
Mermel, et al.
CDC/NHSN – Guidelines for the prevention of intravascular catheter related infections.
2011. Naomi P. O'Grady, M.D.1, et al.
CDC/NHSN – Bloodstream Infection Event (Central Line-Associated Bloodstream Infection
and Non-central line-associated Bloodstream Infection). January 2016.
Scott, Douglas II (2008). The Direct Medical Costs of Healthcare-Associated Infections in
U.S. Hospitals and the Benefits of Prevention. March 2009.
http://www.cdc.gov/hai/pdfs/hai/scott_costpaper.pdf
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; 168:400–7.
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: 361–98.