End-stage Renal Disease Clinical Trial
Official title:
Prospective Trial for Comparison of a TauroLock™ Based Regimen to 4% Citrate as Lock Solution in Tunneled Haemodialysis Catheters for the Prevention of Bacteraemia and Dysfunction
Catheter infections and dysfunctions are a major cause of morbidity and mortality in
haemodialysis patients. According to the US Renal Data System, infection is the second
leading cause of death in dialysis patients and the leading cause of catheter removal and
morbidity in patients with end-stage renal disease.
There is evidence that catheter lock solutions containing taurolidine reduce the risk of
catheter related infections and improve catheter patency. Lock solutions have a local, but
no systemic effect. In this study a taurolidine based lock regimen (TauroLock™-Hep500,
Tauropharm, Waldbüttelbrunn, Germany, 2x/week and TauroLock™-U25.000, Tauropharm,
Waldbüttelbrunn, Germany, 1x/ week) will be compared to 4% citrate (CitraFlow™ 4%, MedXL,
Montreal, Canada, 3x/week) as standard lock solution.
The objective of this study is to evaluate if a TauroLock™ based regimen to lock tunneled
haemodialysis catheters has reducing effects on catheter related blood stream infections and
catheter dysfunctions.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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