Zuragen™ antiseptic catheter lock: A bridge too far?

Autor:	Stephen R, Ash
Rok vydání:	2022
Předmět:	Biomaterials Catheterization Central Venous Renal Dialysis Catheter-Related Infections Anti-Infective Agents Local Biomedical Engineering Anticoagulants Central Venous Catheters Humans Medicine (miscellaneous) Bioengineering General Medicine
Zdroj:	Artificial Organs. 46:1937-1941
ISSN:	1525-1594 0160-564X
DOI:	10.1111/aor.14360
Popis:	When sodium citrate is used as an anticoagulant catheter lock the best concentration is 7%, since this provides a density approximately the same as blood. Our laboratory found that the addition of methylene blue and parabens greatly augmented antibacterial properties. Ash Access sponsored a randomized clinical trial in 400 dialysis patients with tunneled CVC, and this showed a significant decrease in incidence of catheter-related bloodstream infection (CRBSI) defined by stringent criteria. The FDA decided that the study missed its primary endpoint, and that the product was mis-classified, so they did not give approval to market. The licensee decided not to appeal to the decision to the physician panel and ended support of the project. Rights to market the catheter lock eventually returned to Ash Access.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::601729549bda93245a5f72c87a33a392 https://doi.org/10.1111/aor.14360 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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