Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters
11 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Gürkan Sengölge, Assoc. Prof
- Numéro de téléphone: +43 1 40400 43890
- E-mail: guerkan.sengoelge@meduniwien.ac.at
Lieux d'étude
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Vienna, L'Autriche
- Medical University of Vienna
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Contact:
- Gürkan Sengölge, Assoc. Prof.
- Numéro de téléphone: +43 1 40400-43890
- E-mail: guerkan.sengoelge@meduniwien.ac.at
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Catheter dysfunction
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Need for reversal of catheter lines
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
1 août 2027
Achèvement de l'étude (Estimé)
31 décembre 2027
Dates d'inscription aux études
Première soumission
11 juin 2026
Première soumission répondant aux critères de contrôle qualité
11 juin 2026
Première publication (Réel)
18 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 juin 2026
Dernière vérification
1 mars 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Processus pathologiques
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladie chronique
- Attributs de la maladie
- Insuffisance rénale
- Conditions pathologiques, signes et symptômes
- Insuffisance rénale chronique
Autres numéros d'identification d'étude
- 1987/2025
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .