Estimating Blood [Lactate] Non-Invasively

March 19, 2024 updated by: Virend Somers, MD, PhD, Mayo Clinic

Validation of a Non-Invasive Instrument to Estimate Blood Lactate

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood [lactate] during incremental exercise
Time Frame: 1 day
Measured via venous blood and the LabClasp
1 day
Blood [lactate] measurements in ICU patients
Time Frame: 1 day
Measured via venous blood and the LabClasp
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Virend Somers, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21-000318

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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