Catheter Infections, End-stage Renal Disease
Conditions
Keywords
Catheter, Dysfunctions, Blood Stream Infections, Haemodialysis, Taurolidine, Tunneled
Brief summary
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.
Interventions
DEVICE4% citrate lock solution regimen
(CitraFlow™ 4%, MedXL, Montreal, Canada) will be injected in each of the 2 lumens of the tunneled catheters after each dialysis session (2ml/lumen, 3x/week).
DEVICETauroLock lock solution regimen
After the first two dialysis sessions of the week (before the short intervals) 2 ml of TauroLock™-Hep500 containing 1% (cyclo)-taurolidine, 4% citrate and 500 IU/mL heparin will be injected into each of the two lumens of the tunneled catheter. After the third dialysis of the week, thus before the long interval, 2 ml of TauroLock™-U25.000 which contains 1% (cyclo)-taurolidine, 4% citrate and 25.000 IU urokinase will be applied into each lumen.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged greater than 18 years. * Written informed consent. * Requirement for haemodialysis using a tunneled dialysis catheter.
Exclusion criteria
* Children aged less than 18 years. * Positive blood culture in previous seven days before catheter insertion. * Heparin induced thrombocytopenia and any contraindication for anticoagulation (recent or planned surgery, thrombocytopenia \< 70G/l, bleeding disorder).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Catheter Related Blood Stream Infections (CRBSI) | from insertion of the tunneled catheter through study completion, an average of 1 year | Catheter related blood stream infections are defined as infections in patients with tunneled dialysis catheters with a recognized pathogen cultured from blood cultures with no other source of infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Catheter Dysfunctions (inadequate blood flow during dialysis, necessity of catheter rescue with alteplase) | from insertion of the tunneled catheter through study completion, an average of 1 year | catheter function/dysfunction will be assessed during each dialysis session. Parameters to assess catheter dysfunctions numerically are: 1. blood flow during dialysis - inadequate blood flow is defined as blood flow \< 200ml/min or \>30% less than the average of the previous 10 dialysis sessions 2. necessity of catheter rescue with alteplase |
Countries
Austria
Outcome results
None listed