An interventional study of 30 % ethanol / 4% sodium citrate catheter locking solution and Heparin 1000 u / ml in Catheter Related Infection and Bacteremia, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-04.
Sponsored by University of Manitoba · Not applicable, Interventional, and Prevention
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.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 40 is below the median of 120 across 4,201 interventional studies indexed under Infections.
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Exclusion Criteria:
For patients randomized to the 30% ethanol /4 % sodium citrate group, the lock solution will be provided in pre-filled syringes for single use only. After each dialysis session, the locking solution will be instilled into both catheter lumens, the lumens clamped and caps tightly secured to the hubs. Any remaining 30% ethanol/4% sodium citrate solution in each syringe will be discarded. The locking solution will be withdrawn from the catheter lumens before the next dialysis session.
Other: 30 % ethanol / 4% sodium citrate catheter locking solution
For patients randomized to the heparin group, the heparin will be provided in 10 ml glass vials. Two, 3 ml syringes will be used to draw up the required volume of heparin to fill each lumen. A separate syringe will be used to fill each catheter lumen. The necessary volume should match the lumen volume with no overfill. The locking solution will be instilled into both catheter lumens, the lumens clamped and caps tightly secured to the hubs. The locking solution will be withdrawn from the catheter lumens before the next dialysis session.
Drug: Heparin 1000 u / ml
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.
Also known as: Citra Lok Plus
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.
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
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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University of Manitoba