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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
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.
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.
Health Sciences Centre
Winnipeg, Manitoba, Canada
Documentation of Serious Adverse Events (SAE) with the use of a 30% ethanol / 4% sodium citrate catheter locking solution.
This outcome will monitor the safety of the ethanol/sodium citrate catheter locking solution.
Time frame: 6 months
Rate of catheter-related infections per 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
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.
Time frame: 6 months
Rate of catheter dysfunction / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
Catheter function, defined as blood flow \<300 ml/min for 50% of each dialysis session over two consecutive sessions, will be monitored prospectively.
Time frame: 6 months
Rate of alteplase use / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
Need for alteplase use to manage dysfunctional catheters will be documented.
Time frame: 6 months
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