Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters
11 de junio de 2026 actualizado por: Guerkan SENGOELGE, Medical University of Vienna
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Gürkan Sengölge, Assoc. Prof
- Número de teléfono: +43 1 40400 43890
- Correo electrónico: guerkan.sengoelge@meduniwien.ac.at
Ubicaciones de estudio
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Vienna, Austria
- Medical University of Vienna
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Contacto:
- Gürkan Sengölge, Assoc. Prof.
- Número de teléfono: +43 1 40400-43890
- Correo electrónico: guerkan.sengoelge@meduniwien.ac.at
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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.
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Catheter dysfunction
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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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.
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From enrollment to the end of treatment at 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Need for reversal of catheter lines
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Rescue with high dose urokinase (50.000 IU per lumen)
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Total number of catheter-related infections
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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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.
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From enrollment to the end of treatment at 6 months
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Catheter-related infections free survival
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Episodes of antibiotic therapy
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Hospitalization days for catheter-related infectious event
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Hospitalization for all-cause infectious event
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Catheter removal due to infectious and mechanical complication
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Exit-site or tunnel infection
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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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
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From enrollment to the end of treatment at 6 months
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Catheter renewal
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Determine whether Endexo® catheters demonstrate biofilm formation
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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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.
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From enrollment to the end of treatment at 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de agosto de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
11 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de junio de 2026
Publicado por primera vez (Actual)
18 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de junio de 2026
Última verificación
1 de marzo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Insuficiencia renal
- Condiciones Patológicas, Signos y Síntomas
- Insuficiencia Renal Crónica
Otros números de identificación del estudio
- 1987/2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .