Wearable Sweat Sensor for High-Concentration Lactate Monitoring in Critically Ill Patients

July 20, 2026 updated by: Second Affiliated Hospital of Xi'an Jiaotong University

Development and Preliminary Clinical Validation of a Wearable Sweat Sensor for High-Concentration Lactate Monitoring in Critically Ill Patients: A Prospective Cohort Study

Blood lactate level is closely associated with the prognosis of patients with sepsis and septic shock. Clinical guidelines explicitly recommend blood lactate monitoring in septic patients and lactate-guided fluid resuscitation when lactate levels are elevated. Dynamic monitoring of serum lactate changes and calculation of lactate clearance can more accurately reflect the dynamic changes in tissue oxygen supply and consumption, and can be used to evaluate tissue perfusion and oxygen metabolism. However, most existing wearable sweat sensors have a detection range of only 0-20 mmol/L, which is suitable only for monitoring during exercise under normal physiological conditions and cannot meet the clinical monitoring needs of patients with hyperlactatemia. In addition, current wearable sweat lactate sensors suffer from poor reproducibility and are easily affected by environmental factors and complex sweat composition, which represent major obstacles to clinical translation. Therefore, this project aims to develop a wearable sweat sensor for high-concentration lactate monitoring and to conduct preliminary clinical validation in critically ill patients, by simultaneously measuring blood and sweat lactate concentrations and establishing their correlation, with the goal of achieving non-invasive and convenient disease monitoring through sweat biomarker detection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Detailed Description

Over the past decade, the wearable electronics industry has seen exponential growth in demand for continuous health monitoring technologies. From smartwatches to electronic skin, wearable devices have expanded their focus beyond biophysical signals to include biochemical signals such as small-molecule substances and macromolecular proteins in sweat. However, wearable sweat sensing technology still faces significant challenges, including discomfort and skin irritation caused by sweat-inducing materials, effective sweat extraction and collection capability, continuity and reliability of sweat sensing data, sensor calibration, and understanding of sweat analysis methods to discover clinically valuable new biomarkers. Therefore, how to translate wearable sweat monitoring devices into stable, continuous clinical use-matching the needs of health monitoring, disease diagnosis, and precision medicine-remains a research hotspot and challenge.

Lactate is abundant in sweat and is a hallmark product of anaerobic metabolism. Abnormal lactate levels are associated with multiple diseases. As an important marker of tissue perfusion, blood lactate level is closely associated with the prognosis of patients with severe sepsis and septic shock. Clinical guidelines explicitly recommend blood lactate monitoring in septic patients and lactate-guided fluid resuscitation when lactate levels are elevated. Dynamic monitoring of serum lactate changes and calculation of lactate clearance can more accurately reflect dynamic changes in tissue oxygen supply and consumption, and evaluate tissue perfusion and oxygen metabolism. Studies have shown that a lactate clearance rate ≥10% within 6 hours of resuscitation may predict lower mortality in septic patients. Clinical research has also shown that serum lactate concentration can be used to guide clinical treatment decisions, serving as both a therapeutic target and a prognostic indicator. However, most existing wearable sweat sensors have a detection limit of only 0-20 mmol/L, suitable only for exercise monitoring under normal physiological conditions, and cannot meet the clinical need for monitoring hyperlactatemia patients, whose lactate levels can reach up to 100 mmol/L. In addition, current wearable sweat lactate sensors suffer from poor reproducibility and are easily affected by environmental factors and complex sweat composition, posing major obstacles to clinical translation.

Based on this, the investigators have designed an intelligent wearable device for high-concentration sweat lactate monitoring, which includes a lactate detection electrode, a pH detection electrode, a temperature detection electrode, a sweat-stimulating electrode, a microfluidic sweat collection device, a hydrogel patch for inducing sweating, a flexible integrated circuit, and an intelligent display system. This wearable sweat lactate sensor achieves a detection range of up to 100 mmol/L, with a sensitivity of 89 nA/(cm²·mM) and a response time of 150 seconds, and achieves non-exercise-induced sweating through electrical stimulation. In addition, given the sensitivity of the lactate oxidase sensor to temperature and pH, corresponding temperature and pH sensors have been designed for calibration purposes.

This study is a prospective cohort study to be conducted in the surgical intensive care unit (ICU). Critically ill patients with blood lactate concentration >1.5 mmol/L will be enrolled and divided into two groups: (1) a sweat collection group, in which sweat will be collected using a commercial sweat collection device (HELA) for laboratory (ELISA) analysis; and (2) a wearable device monitoring group, in which patients will wear the investigator-designed wireless wearable sweat sensor for real-time monitoring. Clinical data, including medical history, imaging, and laboratory results, will be collected concurrently. The correlation between sweat and blood lactate concentrations, as well as the accuracy and safety of the wearable device, will be evaluated using Pearson correlation analysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients admitted to the surgical intensive care unit (ICU) of the First Affiliated Hospital of Xi'an Jiaotong University with blood lactate concentration greater than 1.5 mmol/L, indicating hyperlactatemia associated with conditions such as sepsis or septic shock. Eligible patients will be assigned to either a sweat collection group or a wearable device monitoring group for concurrent measurement of blood and sweat lactate concentrations.

Description

Inclusion Criteria:

  • Admitted to the surgical intensive care unit (ICU)
  • Blood lactate concentration > 1.5 mmol/L
  • Age ≥ 16 years
  • Willing to voluntarily donate samples and provide signed informed consent

Exclusion Criteria:

  • Pregnant women
  • Pre-existing hematologic disease prior to infection
  • Long-term use of immunosuppressive agents or presence of immunodeficiency
  • Skin too dry to allow adequate sweat collection

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Wearable Device Monitoring Group
Device: High-Concentration Sweat Lactate Wearable Monitoring Device
A flexible wireless wearable device integrating a lactate detection electrode, pH detection electrode, temperature detection electrode, sweat-stimulating electrode, microfluidic sweat collection module, sweat-inducing hydrogel patch, and flexible integrated circuit with an intelligent display system. The device induces localized non-exercise sweating via electrical stimulation and enables real-time detection of sweat lactate concentration up to 100 mmol/L.
Sweat Collection Group
Device: Commercial Sweat Collection Device (HELA)
A commercially available sweat collection device (HELA) used to collect sweat samples from critically ill patients at the time of routine blood draws for clinical lactate testing. Collected sweat samples are subsequently analyzed for lactate concentration using ELISA in the laboratory.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sweat Lactate Concentration
Time Frame: At the time of enrollment, concurrent with clinical blood lactate testing (within the ICU stay, up to approximately 12 months of enrollment period)
Sweat lactate concentration will be measured in critically ill patients with blood lactate concentration >1.5 mmol/L, either via laboratory (ELISA) analysis of sweat samples collected using a commercial sweat collection device, or via real-time detection using the investigator-designed wearable sweat sensor. The correlation between sweat and blood lactate concentrations will be analyzed using Pearson correlation to establish the sweat lactate concentration range corresponding to hyperlactatemia.
At the time of enrollment, concurrent with clinical blood lactate testing (within the ICU stay, up to approximately 12 months of enrollment period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation Between Sweat Lactate Concentration Measured by the Wearable Device and Blood Lactate Concentration Measured by Standard Clinical Testing
Time Frame: Throughout the device-monitoring period during ICU stay (up to 12 months)
Sweat lactate concentration (mmol/L) obtained from the wearable device will be compared with corresponding blood lactate concentration (mmol/L) obtained through standard clinical laboratory testing, using correlation analysis (e.g., Pearson or Spearman correlation coefficient) and Bland-Altman agreement analysis.
Throughout the device-monitoring period during ICU stay (up to 12 months)
Number of Participants With Device-Related Skin Adverse Events
Time Frame: Throughout the device-monitoring period during ICU stay (up to 12 months)
Number of participants experiencing skin irritation, discomfort, or other adverse events at the sensor application site, assessed through clinical observation during device use.
Throughout the device-monitoring period during ICU stay (up to 12 months)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital of Xi'an Jiaotong University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJTUSAH-WB-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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