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

Universitair Ziekenhuis Brussel

Status and phase: Completed; Phase 3

Conditions: Infection; Patency

Treatments: Drug: Taurolidine Urokinase; Drug: Taurolidine Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02036255

TL-001

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

Taurolidine Urokinase

Experimental group

Description:

Taurolock Urokinase is used weekly in this arm substituting the classic Taurolock HEP500

Treatment:

Drug: Taurolidine Heparin

Drug: Taurolidine Urokinase

Taurolidine Heparin

Active Comparator group

Description:

Taurolock HEP 500 is used as locking solution after each dialysis session

Treatment:

Drug: Taurolidine Heparin