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NCT Number: NCT01394458

Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution: 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.

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Key information

Conditions

Catheter Related Infection Bacteremia Bacterial Infections Bacterial Infections and Mycoses Catheter-Related Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

30 % ethanol / 4% sodium citrate catheter locking solution

Other

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

Heparin 1000 u / ml

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • MED XL Inc
  • Winnipeg Regional Health Authority

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 14, 2011
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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