Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters
Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA)
Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA): In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population.
Study summary
There is evidence that central venous catheters made of the permanent and non-eluting integral polymer Endexo® are more resistant to intraluminal thrombosis. This has a direct reducing effect on catheter malfunctions. Indirectly, due to reduced handling of the dysfunctional catheter, this may lead to a diminished rate of catheter related infections. Since catheter malfunctions and infections represent leading complications in a dialysis population, dialysis catheters produced with Endexo® technology have the potential to have beneficial clinical effects. In addition to improving patient outcomes, this could also reduce overall costs. In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adult patients aged greater than 18 years
* Written informed consent
* Requirement for hemodialysis using a tunneled dialysis catheter
Exclusion Criteria:
* Children aged less than 18 years
* Uncontrolled infection; defined as positive blood culture in the past seven days before catheter insertion and/ or elevated C-reactive protein \[CRP \>5 mg/dl (normal \<0.5 mg/dl)\] at screening
Primary outcome measure(s)
Catheter dysfunction — From enrollment to the end of treatment at 6 months Catheter dysfunction will be defined as inadequate blood flow during dialysis (blood flow \< 200mL/min or \>30% less than the average of the previous 10 sessions) and if present before or during dialysis, patient repositioning or reversal of catheter lines will be performed. If not successful, Taurolock Urokinase with a final Urokinase of 50.000 IU will be instilled per lumen either with a 30-minute dwell time before dialysis or as CLS in the inter-dialytic time as rescue. If urokinase is not effective after repeated use the dialysis catheter will be removed.
Trial sites (1)
Facility
City
Region
Status
Medical University of Vienna
Vienna
Austria
More Medical University of Vienna trials in Austria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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