Postmarketing experience with Neutrolin® (taurolidine, heparin, calcium citrate) catheter lock solution in hemodialysis patients | Health & Environmental Research Online (HERO)

HERO ID

6267349

Reference Type

Journal Article

Title

Postmarketing experience with Neutrolin® (taurolidine, heparin, calcium citrate) catheter lock solution in hemodialysis patients

Author(s)

Castanheira, M; Pfaffle, AE; Polsky, B; Reidenberg, BE; Shelip, A; Stalleicken, D; Wanner, C

Year

2018

Is Peer Reviewed?

Yes

Journal

European Journal of Clinical Microbiology and Infectious Diseases
ISSN: 0934-9723
EISSN: 1435-4373

Issue

4

Abstract

Catheter-related bloodstream infections (CRBSI) are major complications for patients with life-threatening conditions requiring chronic vascular catheterization. The wide range of etiologic microbes and the ongoing development of resistance to antimicrobials with specific mechanisms of action make this an appropriate target for applying a nonspecific antimicrobial therapeutic. Taurolidine hydrolyzes into two antimicrobial moieties, formaldehyde and methylene glycol, which react with microbial surfaces. Neutrolin® (taurolidine, heparin, calcium citrate) was recently introduced in Germany as an antimicrobial catheter lock solution. This postmarketing experience collected data on 201 patients at 20 centers from January 2014 through September 2016. Likely CRBSI was observed in 13 episodes in 47,118 days (0.2759 per 1000 days [0.1468, 0.4718]). Thrombosed catheter was observed in seven catheters in 47,118 days (0.1486 per 1000 days [0.0595, 0.3061]). No adverse drug reactions that led to the discontinuation of Neutrolin® use were reported. Two patients experienced occasional transient dysgeusia. Neutrolin®, when used in conjunction with guideline-based catheter care, showed reduction in the rate of both CRBSI and catheter thrombosis relative to recent historical controls.

Keywords

Anti-Bacterial Agents/administration & dosage/adverse; effects/therapeutic use; Calcium Citrate/administration & dosage/adverse effects/therapeutic; Catheter-Related Infections/drug therapy/epidemiology/prevention & control; Central Venous Catheters; Drug Combinations; Germany/epidemiology; Heparin/administration & dosage/adverse effects/therapeutic use; Product Surveillance, Postmarketing; Renal Dialysis; Taurine/administration & dosage/adverse effects/analogs & derivatives/therapeutic use; Thiadiazines/administration & dosage/adverse effects/therapeutic use; Thrombosis/drug therapy/epidemiology/prevention & control; 1EQV5MLY3D; 8OBZ1M4V3V; 9005-49-6; MLM29U2X85