Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters

ConditionsHaemodialysis Haemodialysis Complication Vascular Access Vascular Access Complication ESRD (End Stage Renal Disease)Dialysis Access Dysfunction Dialysis Catheter Dialysis Catheter Infections

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMedical University of Vienna

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged greater than 18 years

Written informed consent

Requirement for hemodialysis using a tunneled dialysis catheter

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA)
Device
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.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Insertion of a tunneled hemodialysis catheter with Endexo® technology for haemodialysis treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

Catheter dysfunction

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.

Time frame