This study is not yet accepting patients

Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid

a study on Biomarkers Acute Kidney Injury Sepsis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

The goal of this observational study is to understand whether a wearable sensor (the Nutromics Sensor Device) can accurately measure drug and biomarker levels in the fluid just under the skin (interstitial fluid), instead of needing repeated blood draws, in adults admitted to hospital who are being treated with the antibiotic vancomycin or who are being monitored for signs of sepsis. The main questions it aims to answer are:

  • How closely do interstitial fluid levels of vancomycin match levels measured in the blood at the same time?
  • How closely do interstitial fluid levels of creatinine, C-reactive protein, and lactate (biomarkers linked to kidney function, inflammation, and infection severity) match levels measured in the blood?
  • Can the device pick up on early biomarker trends that signal a patient may be developing acute kidney injury?
  • How well does the device work overall, and does it perform consistently across different patients (by age, sex, ethnicity, body size, and health conditions) and over time?
  • Is the device safe to wear?

There is no comparison group receiving a different treatment. This study looks at how well the device's readings line up with standard blood tests, not about testing a new treatment.

Participants will:

  • Wear up to two small sensor patches on their upper arm during their hospital stay (up to 5 days), with each patch replaced every 48 hours
  • Have blood samples taken as part of their routine care so results can be compared
  • Have their medical records reviewed 30 days after finishing the study to check on their health outcomes

Official Title

Vancomycin Exposure, Nephrotoxicity, and Sepsis Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid

Keywords

Biomarkers, Acute Kidney Injury, Sepsis, Vancomycin, Wearable Electronic Devices, Interstitial Fluid, Extracellular Fluid

Eligibility

You can join if…

Open to people ages 18 years and up

  • Capable of providing informed consent OR has a Medical Treatment Decision Maker who can provide informed consent per the informed consent form (ICF).
  • Aged 18 years at time of enrolment.
  • Prescribed vancomycin treatment for intravenous administration (Cohort 1 only); vancomycin treatment duration expected to be ≥48 hours from time of enrolment.
  • Has a central or arterial catheter and/or a large-bore cannula, or is willing to have intermittent peripheral blood sampling.

You CAN'T join if...

  • Currently receiving an investigational drug or device that, in the Investigator's opinion, may affect participation in this trial.
  • History of allergic reactions to metals, plastics and adhesives which, in the opinion of the Study Investigators, would increase the risk of allergic reaction associated with the Device.
  • Dermatological (or other) condition, or fragile skin, which in the opinion of the Investigators would prevent application of the Nutromics Sensor Device.
  • Severe oedema or local swelling at the intended application site that would likely impair ISF sampling.
  • Immediate life-threatening instability where study procedures would interfere with urgent care (participant may be screened once stable).
  • Pregnant, lactating, planning to become pregnant, breastfeed, or donate ova.

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • Kaiser Permanente
    Oakland California 94611 United States
  • Stanford
    Stanford California 94305 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Nutromics
ID
NCT07893223
Study Type
Observational
Participants
Expecting 200 study participants
Last Updated