Concentrated sodium citrate catheter lock: "The best laid schemes o' mice an' men…"

Our laboratory's in vitro studies showed that sodium citrate at concentrations from 23% to 47% is antibacterial, and a non-randomized clinical trial showed that its use as a lock solution in dialysis catheters greatly decreased the incidence of CRBSI. The licensee placed 30 ml bottles of 47% sodium citrate in kits containing the Ash Split Cath, with clear instructions to dilute the solution and inject only the catheter volume as a catheter lock. Gross misuse of the solution by one physician led to a serious adverse outcome. FDA instructed the company to remove the product from the market and issued a warning not to use concentrated citrate off-label. Sodium citrate at 23%-30% is widely used in Europe, without major complications or side effects. However, our EPO patent was contested by a Dutch company and they eventually prevailed.