Patency, Infection
Conditions
Keywords
Prevention, Thrombosis, Hemodialysis, Vascular access device
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.
Interventions
DRUGTaurolidine Urokinase
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Requirement of Urokinase | 6 months | Requirement of Urokinase for thrombotic malfunction of dialyse catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Removal of dialysis catheter | 6 months | Removal of dialysis catheter for thrombosis and for bacteremia |
Other
| Measure | Time frame |
|---|---|
| Comparison of the monthly cost of both procedures | 6 months |
Countries
Belgium
Outcome results
None listed