An observational study in Biomarkers, Acute Kidney Injury and Sepsis, sponsored by Nutromics. Not yet recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Nutromics · Observational
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:
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:
1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.
This study's planned enrollment of 200 is above the median of 156 across 795 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →This is the only study on the registry with Nutromics as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Hospitalized participants in the US.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Hospitalised participants receiving vancomycin (Vancomycin monitoring)
Hospitalised participants not receiving vancomycin (Biomarker Monitoring)
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 5 days
Device performance across patient subgroups
Exploratory analysis of Peak Plasma Concentration (Cmax) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to 5 days
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
Of 350 observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 41. This study's planned 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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