Prevention of Dialysis Catheter Malfunction With Prophylactic Use of a Taurolidine Containing Urokinase

May 2, 2018 updated by: Bonkain Florence, Universitair Ziekenhuis Brussel

Prevention of Tunneled Cuffed Catheter Malfunction With Prophylactic Use of a Taurolidine Locking Solution Containing Urokinase : a Multicentric Randomized Controlled Trial

The objective of our study is to investigate whether the substitution of the standard locking solution with a locking solution containing taurolidine and urokinase weekly (Taurolock ™ U 25,000 - www.taurolock.com ) reduces the rate of catheter dysfunction in hemodialysis patients with a history of TCC dysfunction requiring urokinase therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 3

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

  • Belgium
      • Antwerpen, Belgium
        • UZ Antwerpen
      • Brussels, Belgium, 1050
        • Ixelles Hospital
      • Ghent, Belgium
        • Ghent Hospital
    • Brussels
      • Anderlecht, Brussels, Belgium, 1070
        • Bracops Hospital
      • Ixelles, Brussels, Belgium, 1050
        • Ixelles Hospital
      • Jette, Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel
      • Jette, Brussels, Belgium, 1090
        • Brugman Hospital
    • Hainaut
      • Charleroi, Hainaut, Belgium
        • CHU Charleroi
      • Tournai, Hainaut, Belgium, 7500
        • CHWAPI

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult, prevalent hemodialysis patients
  • Informed and consented
  • Hemodialysis 3x/week via a tunneled cuffed catheter
  • Urokinase administration at least two times during the previous 6 months (with more than a week between 2 administrations)
  • Adequate catheter function during the week before inclusion (defined by blood flow more than 250ml/min on each dialysis session and blood flow within 15% of the maximal blood flow after the last Urokinase administration)

Exclusion Criteria:

  • Presence of heparin-induced thrombocytopenia
  • Major hemorrhage or intracranial bleeding in the previous 3 months
  • Pericarditis
  • Intolerance to Taurolidine, citrate or to Urokinase
  • Active catheter-related infection
  • Catheter in the femoral vein

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Taurolidine Urokinase
Taurolock Urokinase is used weekly in this arm substituting the classic Taurolock HEP500
Drug: Taurolidine Urokinase
Other Names:
  • Taurolock Urokinase 25,000
Drug: Taurolidine Heparin
Other Names:
  • Taurolock HEP 500
Active Comparator: Taurolidine Heparin
Taurolock HEP 500 is used as locking solution after each dialysis session
Drug: Taurolidine Heparin
Other Names:
  • Taurolock HEP 500

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Requirement of Urokinase
Time Frame: 6 months
Requirement of Urokinase for thrombotic malfunction of dialyse catheter
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Removal of dialysis catheter
Time Frame: 6 months
Removal of dialysis catheter for thrombosis and for bacteremia
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Comparison of the monthly cost of both procedures
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Florence FB Bonkain, MD, Universitair Ziekenhuis Brussel

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

May 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

January 11, 2014

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TL-001

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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