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

December 3, 2015 updated by: Dr. Lavern M. Vercaigne, University of Manitoba

Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution to Prevent Hemodialysis Catheter-Related Infections: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Other Names:
  • Citra Lok Plus
Experimental: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Documentation of Serious Adverse Events (SAE) with the use of a 30% ethanol / 4% sodium citrate catheter locking solution.
Time Frame: 6 months
This outcome will monitor the safety of the ethanol/sodium citrate catheter locking solution.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of catheter-related infections per 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
Time Frame: 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.
6 months
Rate of catheter dysfunction / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
Time Frame: 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.
6 months
Rate of alteplase use / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.
Time Frame: 6 months
Need for alteplase use to manage dysfunctional catheters will be documented.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Winnipeg Regional Health Authority
MED XL Inc

Investigators

  • Principal Investigator: Lavern Vercaigne, Pharm.D., University of Manitoba
  • Principal Investigator: Lisa Miller, MD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 4, 2011

First Submitted That Met QC Criteria

July 13, 2011

First Posted (Estimate)

July 14, 2011

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Al452-0005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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