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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Non-systemic intraluminal application of 4% citrate lock solution (CitraFlow™ 4%, MedXL, Montreal, Canada) 3 times per week after dialysis. |
|
| Test | Experimental | TauroLock™ based lock solution regimen: Non-systemic intraluminal application of TauroLock™-Hep500, Tauropharm, Waldbüttelbrunn, Germany, 2x/week after dialysis (before short intervals) and TauroLock™-U25.000, Tauropharm, Waldbüttelbrunn, Germany, 1x/ week after dialysis (before long interval). TauroLock™-Hep500 contains 1% (cyclo)-taurolidine, 4% citrate and 500 IU/mL heparin. TauroLock™-U25.000 contains 1% (cyclo)-taurolidine, 4% citrate and 25.000 IU urokinase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4% citrate lock solution regimen | Device | (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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Catheter Related Blood Stream Infections (CRBSI) | 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. | from insertion of the tunneled catheter through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Catheter Dysfunctions (inadequate blood flow during dialysis, necessity of catheter rescue with alteplase) | catheter function/dysfunction will be assessed during each dialysis session. Parameters to assess catheter dysfunctions numerically are:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guerkan Sengoelge, MD | Medical University of Vienna, Department of Medicine III, Division of Nephrology and Dialysis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna | Vienna | State of Vienna | 1180 | Austria |
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| TauroLock lock solution regimen | Device | 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. |
|
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| from insertion of the tunneled catheter through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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