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NCT Number: NCT07655544

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

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.

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Key information

Conditions

Haemodialysis Chronic Disease Dialysis Access Dysfunction Dialysis Catheter Dialysis Catheter Infections Disease Attributes ESRD (End Stage Renal Disease) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Haemodialysis Complication Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Access Vascular Access Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Catheter dysfunction

    Time frame: 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 outcomes

  1. Need for reversal of catheter lines

    Time frame: From enrollment to the end of treatment at 6 months

  2. Rescue with high dose urokinase (50.000 IU per lumen)

    Time frame: From enrollment to the end of treatment at 6 months

  3. Total number of catheter-related infections

    Time frame: 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.

  4. Catheter-related infections free survival

    Time frame: From enrollment to the end of treatment at 6 months

  5. Episodes of antibiotic therapy

    Time frame: From enrollment to the end of treatment at 6 months

  6. Hospitalization days for catheter-related infectious event

    Time frame: From enrollment to the end of treatment at 6 months

  7. Hospitalization for all-cause infectious event

    Time frame: From enrollment to the end of treatment at 6 months

  8. Catheter removal due to infectious and mechanical complication

    Time frame: From enrollment to the end of treatment at 6 months

  9. Exit-site or tunnel infection

    Time frame: 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

  10. Catheter renewal

    Time frame: From enrollment to the end of treatment at 6 months

  11. Determine whether Endexo® catheters demonstrate biofilm formation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gürkan Sengölge, Assoc. Prof

CONTACT

[email protected]

+43 1 40400 43890

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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