Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA).
- Who it may be relevant to
- Registry conditions: Haemodialysis, Haemodialysis Complication, Vascular Access, Vascular Access Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters (Silicone or Polyurethane): A Pilot Study
Overview
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
- Device 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.
Primary outcome measures
- Catheter dysfunction [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (11)
- Need for reversal of catheter lines [Time frame: From enrollment to the end of treatment at 6 months]
- Rescue with high dose urokinase (50.000 IU per lumen) [Time frame: From enrollment to the end of treatment at 6 months]
- Total number of catheter-related infections [Time frame: From enrollment to the end of treatment at 6 months]
- Catheter-related infections free survival [Time frame: From enrollment to the end of treatment at 6 months]
- Episodes of antibiotic therapy [Time frame: From enrollment to the end of treatment at 6 months]
- Hospitalization days for catheter-related infectious event [Time frame: From enrollment to the end of treatment at 6 months]
- Hospitalization for all-cause infectious event [Time frame: From enrollment to the end of treatment at 6 months]
- Catheter removal due to infectious and mechanical complication [Time frame: From enrollment to the end of treatment at 6 months]
- Exit-site or tunnel infection [Time frame: From enrollment to the end of treatment at 6 months]
- Catheter renewal [Time frame: From enrollment to the end of treatment at 6 months]
- Determine whether Endexo® catheters demonstrate biofilm formation [Time frame: From enrollment to the end of treatment at 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Austria · 1 center
- Medical University of Vienna — Vienna
Publications
- Winnicki W, Herkner H, Lorenz M, Handisurya A, Kikic Z, Bielesz B, Schairer B, Reiter T, Eskandary F, Sunder-Plassmann G, Sengoelge G. Taurolidine-based catheter lock regimen significantly reduces overall costs, infection, and dysfunction rates of tunneled hemodialysis catheters. Kidney Int. 2018 Mar;93(3):753-760. doi: 10.1016/j.kint.2017.06.026. Epub 2017 Sep 8. PMID 28890326
- Kleidon T, Ullman AJ, Zhang L, Mihala G, Chaseling B, Schoutrop J, Rickard CM. How Does Your PICCOMPARE? A Pilot Randomized Controlled Trial Comparing Various PICC Materials in Pediatrics. J Hosp Med. 2018 Aug 1;13(8):517-525. doi: 10.12788/jhm.2911. Epub 2018 Feb 8. PMID 29649341
- El Khudari H, Ozen M, Kowalczyk B, Bassuner J, Almehmi A. Hemodialysis Catheters: Update on Types, Outcomes, Designs and Complications. Semin Intervent Radiol. 2022 Feb 18;39(1):90-102. doi: 10.1055/s-0042-1742346. eCollection 2022 Feb. PMID 35210738
- Butterly DW, Schwab SJ. Dialysis access infections. Curr Opin Nephrol Hypertens. 2000 Nov;9(6):631-5. doi: 10.1097/00041552-200011000-00007. PMID 11128425
Identifiers
NCT: NCT07655544 · 1987/2025