Trial · NCT07893223
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Accuracy of Device-measured vancomycin ISF concentration vs. paired serum concentration | Up 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. |
| Primary | Accuracy of Device-measured biomarker (creatinine, C-reactive protein, lactate) ISF concentration vs. paired serum concentration | Up to 5 days | Determination of accuracy between Device-reported biomarker values and paired serum immunoassay results. |
| Primary | Relationship between ISF analyte concentrations and clinical outcomes | Through 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). |
| Primary | General performance characterisation of the Device | Up to 5 days | Paired precision between simultaneously worn devices; device accuracy throughout wear duration; electrochemical sensor quality metrics. |
| Secondary | Device performance across patient subgroups | Up to 5 days | Exploratory analysis of Peak Plasma Concentration (Cmax) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies). |
| Secondary | Device performance across patient subgroups | Up to 5 days | Exploratory analysis of Time to Peak Concentration (Tmax) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies). |
| Secondary | Device performance across patient subgroups | Up to 5 days | Exploratory analysis of Minimum Blood Plasma Concentration (Cmin) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies). |
| Secondary | Device performance across patient subgroups | Up to 5 days | Exploratory analysis of Area Under the Curve (AUC0-24) by demographic and clinical subgroup (age, sex, ethnicity, BMI, medical conditions/pathologies). |
| Secondary | Stability and precision of the Device over time, compared to standard laboratory assays | Up to 5 days | Assessment of device reporting accuracy compared to reported values from standard laboratory assays across wear duration, including after 48-hour device replacement. |
| Secondary | Incidence of Adverse Events | From first device application to 30 days post study completion | Frequency, severity and seriousness of adverse reactions associated with the Device; descriptive summary of application-site photographs. |
| Secondary | Accuracy of Device-reported trend toward Acute Kidney Injury (AKI) | Up to 5 days | Determination 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07893223/registered