Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution: A Pilot Study

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Collaborators: MED XL Inc; Winnipeg Regional Health Authority
• Treatments: Calcium heparin; Citric Acid; Ethanol; Heparin; Pharmaceutical Solutions; Sodium Citrate

Criteria

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