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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Access; Vascular Access Complication; Dialysis Catheter Infections; Haemodialysis; Haemodialysis Complication; Dialysis Access Dysfunction; ESRD (End Stage Renal Disease); Dialysis Catheter
• Intervention / Treatment: Device: Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gürkan Sengölge, Assoc. Prof; Phone Number: +43 1 40400 43890; Email: guerkan.sengoelge@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria
    • Medical University of Vienna
    • Contact: Gürkan Sengölge, Assoc. Prof.; Phone Number: +43 1 40400-43890; Email: guerkan.sengoelge@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: Insertion of a tunneled hemodialysis catheter with Endexo® technology for haemodialysis treatment; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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
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	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	From enrollment to the end of treatment at 6 months
Catheter renewal		From enrollment to the end of treatment at 6 months
Determine whether Endexo® catheters demonstrate biofilm formation	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.	From enrollment to the end of treatment at 6 months

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Publications and helpful links

General 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.
• 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.
• 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.
• Butterly DW, Schwab SJ. Dialysis access infections. Curr Opin Nephrol Hypertens. 2000 Nov;9(6):631-5. doi: 10.1097/00041552-200011000-00007.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: 1987/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes