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Not yet recruitingNCT07716371Updated Jul 21, 2026

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

An observational study in Sepsis, Severe Sepsis With Septic Shock and Severe Sepsis Without Septic Shock, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
86
Ages
16 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Sepsis
  • Severe Sepsis With Septic Shock
  • Severe Sepsis Without Septic Shock

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03

In context

Sepsis

2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.

This study's planned enrollment of 86 is below the median of 150 across 1,162 observational studies indexed under Sepsis.

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Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University is the lead sponsor of 70 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Pre-existing hematologic disease prior to infection
  • Long-term use of agents or presence of immunodeficiency
  • Skin too dry to allow adequate sweat collection
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

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05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
86 participants (estimated)
Patient registry
No

Groups and cohorts

  • Wearable Device Monitoring Group

    Device: High-Concentration Sweat Lactate Wearable Monitoring Device

  • Sweat Collection Group

    Device: Commercial Sweat Collection Device (HELA)

Interventions

  • DeviceHigh-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.

  • DeviceCommercial 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.

06

What researchers measure

Primary outcomes

  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.

    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)

Secondary outcomes

  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.

    Time frame: 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.

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Oct 2028, 26 months later.

Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 26 months is below that.

Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2026
First posted
Jul 21, 2026
StartEst.
Aug 1, 2026
Primary completionEst.
Oct 1, 2028
CompletionEst.
Oct 1, 2029
Last update
Jul 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07716371
Lead sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Jul 21, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Oct 1, 2028 (estimated)
Completion
Oct 1, 2029 (estimated)
Last update
Jul 21, 2026

Study contacts

Kai Qu
Contact
qukai001@xjtu.edu.cn
+8613609117104

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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