Parenteral nutrition (PN) is a life-sustaining therapy required in patients who do not have a
functioning gastrointestinal tract. This can be either second to surgical removal, or
malfunction (such as in malabsorptive conditions and dysmotility). The intravenous provision
of nutrition requires central venous access where a hyperosmolar nutrient solution can be
infused. A variety of central venous catheters (CVCs) can be used, including peripherally
inserted central catheters (PICC), tunneled catheters and implanted ports. The most common
complication, and most frequent cause of hospitalization in patients on home PN is
bloodstream infection.
There are several new devices or solutions that are being developed to be used as primary
prophylaxis for CRBSI. These include catheters with antibacterial and/or anti-biofilm
properties and different catheter lock solutions. Antibiotic lock solutions have been used
for salvage of central venous catheters in confirmed CRBSI. However, it is not recommended as
a primary prophylaxis due to the creation of resistant organisms. According to the United
States Center for Disease Control (CDC), antibiotics 'should be used only to manage
infection.' However, one antimicrobial solution, taurolidine, has not been found to promote
the emergence of resistant bacterial strains and it has been used successfully as a lock
solution to prevent CRBSI. Although an antibiotic may have anti-biofilm properties in high
concentrations but it does not have anticoagulant properties. Ethanol lock solutions (varying
concentrations, but usually 70%) have also been used successfully to reduce CRBSI, however,
there have been adverse events when they are used in polyurethane lines and it does not
inherently have anticoagulant properties. Historically, citrate lock solution has also been
used to maintain catheter patency, but in a meta-analysis, there was no difference between
heparin and citrate lock with regards to catheter thrombosis or catheter related bloodstream
infection.
Although its use has been evaluated in hemodialysis catheters, there are no known studies
examining the use of a tetra-sodium EDTA catheter lock solution in central venous catheters
of patients on home PN. Although both hemodialysis and home PN require central venous
catheters, there are many differences inherent to the different usages. First, the types of
catheters that are used can differ. There is more variety in the types of catheters used for
home PN. Second, most patients undergo hemodialysis on a fixed schedule, three times per week
for 4 to 8 hours each time, and, for the majority of patients, this is done in-center, with
the assistance of a nurse. On the other hand, home PN is usually administered five or more
days per week, at home, over 12 or more hours. It can be either administered with the
assistance of a home care nurse or by the patient and/or their family/partner. Furthermore,
the substance infused through the catheter is different. Specifically, amino acids and fat
emulsions are usually only infused in home PN, although electrolytes and fluids can be
infused in both.
Kitelock™, 4% tetrasodium EDTA catheter lock solution is the sole product of SterileCare Inc,
a private medical devices and equipment company registered federally in Canada, and based in
Markham, Ontario. Kitelock™ is licensed as a medical device, class 2 (license #96962, issue
date 2016-05-10), by Health Canada.
The aim of this study is to perform cost- and ease-of-use analyses in patients on home
parenteral nutrition.