Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2026-01-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Whole-body exercise in healthy adults (Aim 1)
Subjects will have blood \[lactate\] measurement obtained with the LabClasp device while completing an exercise stress test on a treadmill or bicycle.
LabClasp
Non-invasive device that estimates blood \[lactate\] from interstitial fluid via a proprietary algorithm. The device is placed between the first and second knuckle of a finger and gently applies slight pressure to extract interstitial fluid from the skin. Sensors within the device quickly estimate blood \[lactate\] and return a value to the subject via an accompanying tablet within 20 seconds.
ICU patients susceptible to developing sepsis (Aim 2)
Subjects will have blood \[lactate\] measurement obtained with the LabClasp device as frequently as required for clinical purposes
LabClasp
Non-invasive device that estimates blood \[lactate\] from interstitial fluid via a proprietary algorithm. The device is placed between the first and second knuckle of a finger and gently applies slight pressure to extract interstitial fluid from the skin. Sensors within the device quickly estimate blood \[lactate\] and return a value to the subject via an accompanying tablet within 20 seconds.
Interventions
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LabClasp
Non-invasive device that estimates blood \[lactate\] from interstitial fluid via a proprietary algorithm. The device is placed between the first and second knuckle of a finger and gently applies slight pressure to extract interstitial fluid from the skin. Sensors within the device quickly estimate blood \[lactate\] and return a value to the subject via an accompanying tablet within 20 seconds.
Eligibility Criteria
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Inclusion Criteria
* Adults 18 years of age and older.
* Nonsmokers.
* No recent hospitalization (\< 60 days).
* Ability to perform high-intensity exercise.
* Subjects must be able to provide written consent to be included in the research study.
* Adults 18 years of age and older.
* Nonsmokers.
* Current ICU patient.
* Have regular blood samples taken for \[lactate\] measurements.
* Have one or more risk factors for sepsis.
Exclusion Criteria
* History of HIV with antiretroviral treatment.
* Smokers.
* Pregnancy.
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Virend Somers, MD, PhD
Principal Investigator
Principal Investigators
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Virend Somers
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Other Identifiers
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21-000318
Identifier Type: -
Identifier Source: org_study_id
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