Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution: A Pilot Study
NCT ID: NCT01394458
Last Updated: 2015-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2011-08-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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30 % ethanol/ 4 % sodium citrate group
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 The locking solution will be withdrawn from the catheter lumens before the next dialysis session.
30 % ethanol / 4% sodium citrate catheter locking solution
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.
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 The locking solution will be withdrawn from the catheter lumens before the next dialysis session.
Heparin 1000 u / ml
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.
Interventions
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30 % ethanol / 4% sodium citrate catheter locking solution
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.
Heparin 1000 u / ml
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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MED XL Inc
UNKNOWN
Winnipeg Regional Health Authority
OTHER
University of Manitoba
OTHER
Responsible Party
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Dr. Lavern M. Vercaigne
Professor, Faculty of Pharmacy
Principal Investigators
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Lavern Vercaigne, Pharm.D.
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Lisa Miller, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
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Health Sciences Centre
Winnipeg, Manitoba, Canada
Countries
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References
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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.
Other Identifiers
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Al452-0005
Identifier Type: -
Identifier Source: org_study_id