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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Manitoba

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: University of Manitoba

Dates:
Date Received: July 4, 2011
Date Started: August 2011
Date Completion:
Last Updated: December 3, 2015
Last Verified: December 2015