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Trial · NCT07893223

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAccuracy of Device-measured vancomycin ISF concentration vs. paired serum concentrationUp to 5 Days
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.
PrimaryAccuracy of Device-measured biomarker (creatinine, C-reactive protein, lactate) ISF concentration vs. paired serum concentrationUp to 5 daysDetermination of accuracy between Device-reported biomarker values and paired serum immunoassay results.
PrimaryRelationship between ISF analyte concentrations and clinical outcomesThrough 30 days after study completion
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).
PrimaryGeneral performance characterisation of the DeviceUp to 5 daysPaired precision between simultaneously worn devices; device accuracy throughout wear duration; electrochemical sensor quality metrics.
SecondaryDevice performance across patient subgroupsUp to 5 daysExploratory analysis of Peak Plasma Concentration (Cmax) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies).
SecondaryDevice performance across patient subgroupsUp to 5 daysExploratory analysis of Time to Peak Concentration (Tmax) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies).
SecondaryDevice performance across patient subgroupsUp to 5 daysExploratory analysis of Minimum Blood Plasma Concentration (Cmin) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies).
SecondaryDevice performance across patient subgroupsUp to 5 daysExploratory analysis of Area Under the Curve (AUC0-24) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies).
SecondaryStability and precision of the Device over time, compared to standard laboratory assaysUp to 5 daysAssessment of device reporting accuracy compared to reported values from standard laboratory assays across wear duration, including after 48-hour device replacement.
SecondaryIncidence of Adverse EventsFrom first device application to 30 days post study completionFrequency, severity and seriousness of adverse reactions associated with the Device; descriptive summary of application-site photographs.
SecondaryAccuracy of Device-reported trend toward Acute Kidney Injury (AKI)Up to 5 daysDetermination of accuracy between Device-reported creatinine trend and serum creatinine; AKI assessed per KDIGO Clinical Practice Guideline for Acute Kidney Injury (2012).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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