Clinical trial NCT01394458: Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution: A Pilot Study
Official title: Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution to Prevent Hemodialysis Catheter-Related Infections: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Related Infection
Bacteremia
Keywords: catheter related infection
bacteremia
hemodialysis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: MED XL Inc
name: Winnipeg Regional Health Authority
First posted: 2011-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Documentation of Serious Adverse Events (SAE) with the use of a 30% ethanol / 4% sodium citrate catheter locking solution.
timeFrame: 6 months
Secondary outcomes:
measure: Rate of catheter-related infections per 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
timeFrame: 6 months
measure: Rate of catheter dysfunction / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
timeFrame: 6 months
measure: Rate of alteplase use / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
timeFrame: 6 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Lavern Vercaigne, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Lisa Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vercaigne LM, Allan DR, Armstrong SW, Zacharias JM, Miller LM. An ethanol/sodium citrate locking solution compared to heparin to prevent hemodialysis catheter-related infections: a randomized pilot study. J Vasc Access. 2016 Jan-Feb;17(1):55-62. doi: 10.5301/jva.5000486. Epub 2015 Dec 7.