Estimating Blood [Lactate] Non-Invasively

Mayo Clinic

Status: Not yet enrolling

Conditions: Healthy

Treatments: Device: LabClasp

Study type: Interventional

Funder types: Other

Identifiers

NCT05036122

21-000318

Details and patient eligibility

About

The purpose of this study is to validate the LabClasp's ability to estimate blood [lactate].

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - Aim 1:

• Subjects must be able to provide written consent.
• Adults 18 years of age and older.
• Nonsmokers.
• No recent hospitalization (< 60 days).
• Ability to perform high-intensity exercise.

Inclusion Criteria - Aim 2:

• 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 - Aims 1 and 2:

• History of, or active malignancy.
• History of HIV with antiretroviral treatment.
• Smokers.
• Pregnancy.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Whole-body exercise in healthy adults (Aim 1)

Experimental group

Description:

Subjects will have blood \[lactate\] measurement obtained with the LabClasp device while completing an exercise stress test on a treadmill or bicycle.

Treatment:

Device: LabClasp

ICU patients susceptible to developing sepsis (Aim 2)

Experimental group

Description:

Subjects will have blood \[lactate\] measurement obtained with the LabClasp device as frequently as required for clinical purposes

Treatment:

Device: LabClasp