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

NCT07655544 | Not Yet Recruiting FDA Device

• 1 other identifier: 1987/2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (11)

• 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 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

Study Arms (1)

Insertion of a tunneled hemodialysis catheter with Endexo® technology for haemodialysis treatment

ACTIVE COMPARATOR

Study participants will be recruited among those patients with the need of insertion of a tunneled catheter to perform hemodialysis who attend the recruitment site (Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis) for routine care. A tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be implanted. As a standard catheter lock solution 4% citrate (applied in each of the 2 lumens after each dialysis session) will be used. Care of the tunneled catheter in the study sites will be followed established standards including dressing changes, exit site care and hygiene. After each hemodialysis session the exit site will be inspected and covered with 2.0% chlorhexidine dressing (Tegaderm CHG, 3M, Neuss, Germany). Chronic haemodialyisis treatment will be held in a regular setting based on the patient's dialysis requirements.

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

Interventions

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.

Insertion of a tunneled hemodialysis catheter with Endexo® technology for haemodialysis treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged greater than 18 years
• Written informed consent
• Requirement for hemodialysis using a tunneled dialysis catheter

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gürkan Sengölge, Assoc. Prof

CONTACT

+43 1 40400 43890; guerkan.sengoelge@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv.-Doz. Dr. med.univ.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-03

Locations

AU (1)