Continuous monitoring of Intensive Care Unit (ICU) patients’ vancomycin levels in interstitial fluid: a pilot feasibility study of a new device

Part 1: Adults in ICU prescribed vancomycin will be invited to participate in the study. Participants can be enrolled if their guardian provides consent prior to applying the device. These participants will be approached at a later stage to obtain consent to continue to participate in the study. Consenting participants will have the device applied to the skin (e.g. upper arm) as soon as feasible upon commencing the course of vancomycin. This device will remain in place for 24 hours. A second device will be applied to the skin (e.g. upper arm) 11-12 hours after application of the first device. The second device will remain in place for 12 hours. Both devices are the same Nutromics Sensor Device, meaning, two of the same Nutromics Sensor Device will be applied, one for 24 hours and the other for 12 hours. Photographs will be taken pre and post Device application to assess for adverse events. This process will be repeated on a second occasion. Participants with Intermittent Vancomycin Dosing Regimens: Blood samples (4 mL) will be collected during a dosing interval. Blood samples for the measurement of plasma vancomycin concentration will be collected prior to the administration of the vancomycin infusion in each 24 hour observation period, at the end of the infusion and then at 1, 2, 3, 4, 6, 8 and 10-hours post-the end of each infusion. In addition, any vancomycin concentrations obtained as part of standard care will be recorded. Inflammatory markers (e.g. CRP) will also be tested at the 1 and 10 hour time points for each 24 hour observation period. This blood sampling schedule will be repeated on a second occasion in conjunction with the application of the devices. Participants with Continuous Vancomycin Dosing Regimens: Blood samples (4 mL) will be collected during a continuous infusion. Blood samples for the measurement of plasma vancomycin concentration will be collected 2 hours after the syringe/infusion swap and 2 hours prior to the next syringe/infusion swap. In addition, any vancomycin concentrations obtained as part of standard care will be recorded. Inflammatory markers (e.g. CRP) will also be tested at these time points for each 24-hour observation period. This blood sampling schedule will be repeated on a second occasion in conjunction with the application of the devices. The first Nutromics Sensor Device applied to the patient in the 24 hour observational period will remain on the upper arm of the patient for 24 hours, and the second Device applied 12 hours into the period of observation will remain applied for 12 hours. The Devices are single use, to be applied by a healthcare professional, and have been shown to be relatively painless and have no impact on mobility. Participating in this study will have no impact on their prescribed care or vancomycin therapy. Part 2: After having provided written informed consent an in-depth survey will be conducted with healthcare professionals, including prescribers, nurses and pharmacists, involved in using the device (Part 1) to better understand feasibility, potential utility and impact on practice. Survey questions will focus on current practice and their role in using the device during Part 1. Participants will be asked to comment on the process (feasibility) of integrating the device into routine critical care medicine and any suggestions for improvements.