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SepsisNCT07716371

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

An observational study of Sepsis and Severe Sepsis With Septic Shock, run by Second Affiliated Hospital of Xi'an Jiaotong University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
High-Concentration Sweat Lactate Wearable Monitoring Device and Commercial Sweat Collection Device (HELA)
Type of treatment
Medical device
How many people
86 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 1 Oct 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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.

Read the 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.

Being tested
High-Concentration Sweat Lactate Wearable Monitoring Device, Commercial Sweat Collection Device (HELA)
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Concentration Sweat Lactate Wearable Monitoring DeviceDevice

    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.

  • Commercial Sweat Collection Device (HELA)Device

    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.

Study groups in NCT07716371
Study groupRoleWhat they receive
Wearable Device Monitoring GroupNot described
Receives: Device: High-Concentration Sweat Lactate Wearable Monitoring Device
Sweat Collection GroupNot described
Receives: Device: Commercial Sweat Collection Device (HELA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sweat Lactate Concentration

    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.

    Measured: At the time of enrollment, concurrent with clinical blood lactate testing (within the ICU stay, up to approximately 12 months of enrollment period)

Secondary outcomes (2)
  1. Correlation Between Sweat Lactate Concentration Measured by the Wearable Device and Blood Lactate Concentration Measured by Standard Clinical Testing

    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.

    Measured: Throughout the device-monitoring period during ICU stay (up to 12 months)

  2. Number of Participants With Device-Related Skin Adverse Events

    Number of participants experiencing skin irritation, discomfort, or other adverse events at the sensor application site, assessed through clinical observation during device use.

    Measured: Throughout the device-monitoring period during ICU stay (up to 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Oct 2028 (estimated)
  4. Study completion1 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07716371
Sponsor's protocol ID
XJTUSAH-WB-001
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
21 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Severe Sepsis With Septic Shock, run by Second Affiliated Hospital of Xi'an Jiaotong University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kai Qu (+8613609117104, qukai001@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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