Dialysis Access Dysfunction, Dialysis Catheter, Dialysis Catheter Infections, ESRD (End Stage Renal Disease), Haemodialysis, Haemodialysis Complication, Vascular Access, Vascular Access Complication
Conditions
Brief 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.
Interventions
DEVICEInsertion 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.
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for reversal of catheter lines | From enrollment to the end of treatment at 6 months | — |
| Rescue with high dose urokinase (50.000 IU per lumen) | From enrollment to the end of treatment at 6 months | — |
| Total number of catheter-related infections | From enrollment to the end of treatment at 6 months | Catheter-related infections will be defined as positive bacterial blood culture drawn from the dialysis catheter in a symptomatic patient with fever or chills associated with dialysis and no apparent other source of infection. Blood cultures will be taken using aseptic technique from each lumen of the tunneled catheter and in addition from a peripheral vein whenever possible to determine the differential time to positivity. |
| Catheter-related infections free survival | From enrollment to the end of treatment at 6 months | — |
| Episodes of antibiotic therapy | From enrollment to the end of treatment at 6 months | — |
| Hospitalization days for catheter-related infectious event | From enrollment to the end of treatment at 6 months | — |
| Hospitalization for all-cause infectious event | From enrollment to the end of treatment at 6 months | — |
| Catheter removal due to infectious and mechanical complication | From enrollment to the end of treatment at 6 months | — |
| Exit-site or tunnel infection | From enrollment to the end of treatment at 6 months | Exit site infections will be defined as culturepositive inflammation localized to the exit site, not extending above the cuff. Tunnel infection is defined as culture-positive inflammation within the catheter tunnel internal to the cuff |
| Catheter renewal | From enrollment to the end of treatment at 6 months | — |
| Determine whether Endexo® catheters demonstrate biofilm formation | From enrollment to the end of treatment at 6 months | Explanted catheters (distal tip, intraluminal segments) will be sent to MoKi Analytics GmbH for assessment of biofilm formation using fluorescence in situ hybridization (FISH) according to validated SOPs. |
Countries
Austria
Contacts
CONTACTGürkan Sengölge, Assoc. Prof
Outcome results
None listed