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

Not Applicable

Completed

• Conditions: Catheter Related Infection; Bacteremia
• Interventions: Other: 30 % ethanol / 4% sodium citrate catheter locking solution; Drug: Heparin 1000 u / ml

• Registration Number: NCT01394458
• Lead Sponsor: University of Manitoba

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.

Study Timeline

• Study First Submitted: 2011-07-04
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Study Start: 2011-08
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 % ethanol/ 4 % sodium citrate group	30 % ethanol / 4% sodium citrate catheter locking solution	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.
Heparin 1000 U/ml	Heparin 1000 u / ml	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada