Estimating Blood [Lactate] Non-Invasively

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05036122

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: LabClasp	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Validation of a Non-Invasive Instrument to Estimate Blood Lactate

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Experimental: 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	Device: 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.

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Experimental: 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

Device: LabClasp

Outcome Measures

Primary Outcome Measures

Blood [lactate] during incremental exercise [1 day]
Measured via venous blood and the LabClasp
Blood [lactate] measurements in ICU patients [1 day]
Measured via venous blood and the LabClasp

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Virend Somers, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Virend Somers, MD, PhD, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05036122

Other Study ID Numbers:

21-000318

First Posted:

Sep 5, 2021

Last Update Posted:

Jun 1, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Virend Somers, MD, PhD, Principal Investigator, Mayo Clinic

High intensity exercise

Stress Testing

Study Results

No Results Posted as of Jun 1, 2022