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

Primary Purpose

Catheter Related Infection, Bacteremia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
30 % ethanol / 4% sodium citrate catheter locking solution
Heparin 1000 u / ml
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter Related Infection focused on measuring catheter related infection, bacteremia, hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

30 % ethanol/ 4 % sodium citrate group

Heparin 1000 U/ml

Arm 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 The locking solution will be withdrawn from the catheter lumens before the next dialysis session.

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.

Outcomes

Primary Outcome Measures

Documentation of Serious Adverse Events (SAE) with the use of a 30% ethanol / 4% sodium citrate catheter locking solution.
This outcome will monitor the safety of the ethanol/sodium citrate catheter locking solution.

Secondary Outcome Measures

Rate of catheter-related infections per 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
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 catheter dysfunction / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
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 alteplase use / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
Need for alteplase use to manage dysfunctional catheters will be documented.

Full Information

First Posted
July 4, 2011
Last Updated
December 3, 2015
Sponsor
University of Manitoba
Collaborators
MED XL Inc, Winnipeg Regional Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01394458
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
MED XL Inc, Winnipeg Regional Health Authority

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Related Infection, Bacteremia
Keywords
catheter related infection, bacteremia, hemodialysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
30 % ethanol/ 4 % sodium citrate group
Arm Type
Experimental
Arm 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.
Arm Title
Heparin 1000 U/ml
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
30 % ethanol / 4% sodium citrate catheter locking solution
Other Intervention Name(s)
Citra Lok Plus
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Heparin 1000 u / ml
Intervention Description
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.
Primary Outcome Measure Information:
Title
Documentation of Serious Adverse Events (SAE) with the use of a 30% ethanol / 4% sodium citrate catheter locking solution.
Description
This outcome will monitor the safety of the ethanol/sodium citrate catheter locking solution.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rate of catheter-related infections per 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
Description
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.
Time Frame
6 months
Title
Rate of catheter dysfunction / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
Description
Catheter function, defined as blood flow <300 ml/min for 50% of each dialysis session over two consecutive sessions, will be monitored prospectively.
Time Frame
6 months
Title
Rate of alteplase use / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
Description
Need for alteplase use to manage dysfunctional catheters will be documented.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lavern Vercaigne, Pharm.D.
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Miller, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26660041
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.
Results Reference
derived

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

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