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

University of Manitoba

Status: Completed

Conditions: Bacteremia; Catheter Related Infection

Treatments: Other: 30 % ethanol / 4% sodium citrate catheter locking solution; Drug: Heparin 1000 u / ml

Study type: Interventional

Funder types: Other

Identifiers

NCT01394458

Al452-0005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

30 % ethanol/ 4 % sodium citrate group

Experimental group

Description:

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.

Treatment:

Other: 30 % ethanol / 4% sodium citrate catheter locking solution

Heparin 1000 U/ml

Experimental group

Description:

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.

Treatment:

Drug: Heparin 1000 u / ml