TIP-003 - PILOT STUDY ON VANCOMYCIN ADMINISTRATION VIA DIALYSATE IN PATIENTS RECEIVING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT)

D. Quickfall¹, J. Koyner¹; ¹University of Chicago, Chicago, IL, United States.

Background: Sepsis, a major cause of intensive care unit (ICU) mortality, often leads to renal failure, with up to 20% of patients requiring continuous renal replacement therapy (CRRT). Altered pharmacokinetics and CRRT drug clearance make optimizing vancomycin dosing challenging. This study explores the feasibility of a novel vancomycin administration route through dialysis fluid, aimed at achieving rapid therapeutic levels while minimizing exposure to toxic levels and requiring fewer dosage adjustments compared to intravenous administration.

Methods: This single-center, proof-of-concept study includes ICU patients receiving CRRT via continuous veno-venous hemodialysis (CVVHD) and vancomycin. Instead of the conventional intravenous route, vancomycin will be administered via the dialysate, allowing diffusion into the bloodstream. The primary endpoint is achieving stable therapeutic vancomycin levels (20-25 mg/L) with three consecutive levels taken at 12-hour intervals from the time of first drug administration. Secondary endpoints include the time from first administration to the first therapeutic level and the frequency of supratherapeutic levels (>25 mg/L). Enrollment will target any patients on/starting CRRT receiving vancomycin. Patients with established infections requiring vancomycin as standard care or patients receiving non-CVVHD modalities of dialysis are excluded. IRB approval is complete and patient enrollment is set to begin on October 1, 2024.

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Design: This study introduces a novel route of drug delivery through the dialysate, which is typically used for clearance of solutes, not for drug administration. By leveraging the concentration gradient in the dialysis fluid, this approach minimizes and potentially eliminates the risk of vancomycin toxicity, as therapeutic levels should be achieved without the risk of toxicity. It also ensures stable vancomycin levels during CRRT interruptions. This method has the potential to transform vancomycin dosing in critically ill patients, offering a safer and more efficient alternative to traditional dosing strategies.