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

Universitair Ziekenhuis Brussel8 sites in 1 country68 target enrollmentMay 2015

ConditionsPatency Infection

InterventionsTaurolidine Urokinase Taurolidine Heparin

DrugsTaurolidine Urokinase Taurolidine Heparin

Overview

Phase: Phase 3
Intervention: Taurolidine Urokinase
Conditions: Patency
Sponsor: Universitair Ziekenhuis Brussel
Enrollment: 68
Locations: 8
Primary Endpoint: Requirement of Urokinase
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

May 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universitair Ziekenhuis Brussel

Responsible Party

Principal Investigator

Bonkain Florence

Bonkain Florence, MD, UZ Brussel

Universitair Ziekenhuis Brussel

Eligibility Criteria

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)