Zuragen™ antiseptic catheter lock: A bridge too far?

Abstract

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.

• Authors: Stephen R Ash
• Journal: Artificial organs (Artif Organs) Vol. 46 Issue 9 Pg. 1937-1941 (Sep 2022) ISSN: 1525-1594 [Electronic] United States
• PMID: 35866981 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2022 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.

Chemical References

• Anti-Infective Agents, Local
• Anticoagulants

Topics

• Anti-Infective Agents, Local (therapeutic use)
• Anticoagulants
• Catheter-Related Infections (etiology, prevention & control)
• Catheterization, Central Venous (adverse effects)
• Central Venous Catheters (adverse effects)
• Humans
• Renal Dialysis (adverse effects)