Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA).
- Кому может быть актуально
- Состояния в реестре: Haemodialysis, Haemodialysis Complication, Vascular Access, Vascular Access Complication. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австрия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Вмешательства
- Устройство 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.
Первичные конечные точки
- Catheter dysfunction [Срок оценки: From enrollment to the end of treatment at 6 months]
Вторичные конечные точки (11)
- Need for reversal of catheter lines [Срок оценки: From enrollment to the end of treatment at 6 months]
- Rescue with high dose urokinase (50.000 IU per lumen) [Срок оценки: From enrollment to the end of treatment at 6 months]
- Total number of catheter-related infections [Срок оценки: From enrollment to the end of treatment at 6 months]
- Catheter-related infections free survival [Срок оценки: From enrollment to the end of treatment at 6 months]
- Episodes of antibiotic therapy [Срок оценки: From enrollment to the end of treatment at 6 months]
- Hospitalization days for catheter-related infectious event [Срок оценки: From enrollment to the end of treatment at 6 months]
- Hospitalization for all-cause infectious event [Срок оценки: From enrollment to the end of treatment at 6 months]
- Catheter removal due to infectious and mechanical complication [Срок оценки: From enrollment to the end of treatment at 6 months]
- Exit-site or tunnel infection [Срок оценки: From enrollment to the end of treatment at 6 months]
- Catheter renewal [Срок оценки: From enrollment to the end of treatment at 6 months]
- Determine whether Endexo® catheters demonstrate biofilm formation [Срок оценки: From enrollment to the end of treatment at 6 months]
Критерии участия
Критерии включения
- Adult patients aged greater than 18 years
- Written informed consent
- Requirement for hemodialysis using a tunneled dialysis catheter
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Австрия · 1 центр
- Medical University of Vienna — Vienna
Публикации
- 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
- 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
- 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
- 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
Идентификаторы
NCT: NCT07655544 · 1987/2025