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

NCT01394458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-12-04

No results posted yet for this study

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.

Conditions

  • Catheter Related Infection
  • Bacteremia

Interventions

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.

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.

Sponsors & Collaborators

  • MED XL Inc

    collaborator UNKNOWN

  • Winnipeg Regional Health Authority

    collaborator OTHER

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Lavern Vercaigne, Pharm.D. · University of Manitoba

  • Lisa Miller, MD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01394458 on ClinicalTrials.gov