Bacteremia, Catheter Related Infection
Conditions
Keywords
catheter related infection, bacteremia, hemodialysis
Brief summary
Currently in Canada, either 4% sodium citrate or heparin 1,000-10,000 U/ml solutions are locked into hemodialysis catheters between dialysis sessions to prevent thrombosis. The use of an ethanol/sodium citrate locking solution may have advantages over either of these agents alone. The investigators hypothesize that the 30 % ethanol/4% sodium citrate catheter locking solution is safe and effective in the prevention of catheter-related infections and thrombosis.
Detailed description
The pilot study will utilize a prospective, randomized design. After meeting the inclusion/exclusion criteria and providing written informed consent, patients will be randomly assigned to a 30 % ethanol/ 4% sodium citrate locking solution or heparin 1000 U/ml. Patients will be enrolled from the Health Sciences Centre and the Sherbrook Dialysis Units in Winnipeg, Manitoba, Canada.
Interventions
OTHER30 % ethanol / 4% sodium citrate catheter locking solution
This solution is locked into the lumens of hemodialysis catheters between treatments to prevent infection and thrombosis. Before each dialysis session, the solution should be removed and discarded.
DRUGHeparin 1000 u / ml
In the control group, heparin 1000 u / ml will be locking into the hemodialysis catheters between treatments to prevent thrombosis. The heparin solution should be removed and discarded before each dialysis session.
Sponsors
MED XL Inc
Winnipeg Regional Health Authority
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Stage V chronic kidney disease preparing to start hemodialysis * Exchange of an existing catheter to a cuffed, tunneled catheter OR planned vascular access with a cuffed, tunneled catheter * CVC used for hemodialysis made of alcohol-resistant polymers ie. carbothane
Exclusion criteria
* Patients receiving catheters not made of alcohol resistant polymers * Critically ill patients in ICU setting * Patients with acute renal failure, who will likely not require prolonged vascular access ( ie. \> months) * Patients with maturing fistulas/graft creation within 2 months * Patients with planned antibiotic treatment courses lasting longer than 4 weeks from the date of new catheter insertion * Patients receiving a new cuffed, tunneled catheter over a guide wire, if a fibrin sheath angioplasty was not performed after removing the previous dysfunctional catheter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Documentation of Serious Adverse Events (SAE) with the use of a 30% ethanol / 4% sodium citrate catheter locking solution. | 6 months | This outcome will monitor the safety of the ethanol/sodium citrate catheter locking solution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of catheter-related infections per 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin. | 6 months | This outcome will primarily investigate efficacy of the ethanol/sodium citrate locking solution and help to describe effect size for the design of a larger more definitive study. |
| Rate of catheter dysfunction / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin. | 6 months | Catheter function, defined as blood flow \<300 ml/min for 50% of each dialysis session over two consecutive sessions, will be monitored prospectively. |
| Rate of alteplase use / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin. | 6 months | Need for alteplase use to manage dysfunctional catheters will be documented. |
Countries
Canada
Outcome results
None listed