BiomarkersVENTURENCT07893223
Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
An observational study of Biomarkers and Acute Kidney Injury, run by Nutromics at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biomarkers, Acute Kidney Injury, Sepsis
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2026to Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized participants in the US.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Northwell Health
New Hyde Park, New York, 11040
Columbia University
New York, New York, 10032
Kaiser Permanente
Oakland, California, 94611
University of California, San Francisco
San Francisco, California, 94143
Stanford
Stanford, California, 94305
About this study
Official title: Vancomycin Exposure, Nephrotoxicity, and Sepsis Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
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?
Read more
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
- Conditions
- Biomarkers, Acute Kidney Injury, Sepsis
- Keywords
- Vancomycin, Wearable Electronic Devices, Biomarkers, Interstitial Fluid, Extracellular Fluid
- Medical subject headings
- Acute Kidney Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Hospitalised participants receiving vancomycin (Vancomycin monitoring) | |
| Cohort 2 | Hospitalised participants not receiving vancomycin (Biomarker Monitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Device-measured vancomycin ISF concentration vs. paired serum concentration
Comparison of vancomycin concentration-time profiles and pharmacokinetic parameters (Cmax, Tmax, Cmin, AUC0-24) derived from interstitial fluid (Sensor Device) against paired serum vancomycin immunoassay results.
Measured: Up to 5 Days
Accuracy of Device-measured biomarker (creatinine, C-reactive protein, lactate) ISF concentration vs. paired serum concentration
Determination of accuracy between Device-reported biomarker values and paired serum immunoassay results.
Measured: Up to 5 days
Relationship between ISF analyte concentrations and clinical outcomes
Descriptive summary of association between ISF concentration profiles (vancomycin, creatinine, C-reactive protein, lactate) and 30-day clinical outcomes (discharge/readmission, morbidity, mortality, treatment-emergent adverse events).
Measured: Through 30 days after study completion
General performance characterisation of the Device
Paired precision between simultaneously worn devices; device accuracy throughout wear duration; electrochemical sensor quality metrics.
Measured: Up to 5 days
Secondary outcomes (7)
Device performance across patient subgroups
Exploratory analysis of Peak Plasma Concentration (Cmax) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies).
Measured: Up to 5 days
Device performance across patient subgroups
Exploratory analysis of Time to Peak Concentration (Tmax) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies).
Measured: Up to 5 days
Device performance across patient subgroups
Exploratory analysis of Minimum Blood Plasma Concentration (Cmin) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies).
Measured: Up to 5 days
Device performance across patient subgroups
Exploratory analysis of Area Under the Curve (AUC0-24) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies).
Measured: Up to 5 days
Stability and precision of the Device over time, compared to standard laboratory assays
Assessment of device reporting accuracy compared to reported values from standard laboratory assays across wear duration, including after 48-hour device replacement.
Measured: Up to 5 days
Incidence of Adverse Events
Frequency, severity and seriousness of adverse reactions associated with the Device; descriptive summary of application-site photographs.
Measured: From first device application to 30 days post study completion
Accuracy of Device-reported trend toward Acute Kidney Injury (AKI)
Determination of accuracy between Device-reported creatinine trend and serum creatinine; AKI assessed per KDIGO Clinical Practice Guideline for Acute Kidney Injury (2012).
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutromics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893223
- Sponsor's protocol ID
- NTM-US-2026/013
- Acronym
- VENTURE
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided