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

NCT07716371 | Not Yet Recruiting

• 1 other identifier: XJTUSAH-WB-001
• Study Type: observational
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sepsis; Severe Sepsis With Septic Shock; Severe Sepsis Without Septic Shock

Outcome Measures

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.

  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)

• Correlation Between Sweat Lactate Concentration Measured by the Wearable Device and Blood Lactate Concentration Measured by Standard Clinical Testing

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

• Number of Participants With Device-Related Skin Adverse Events

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

Study Arms (2)

Wearable Device Monitoring Group

Device: High-Concentration Sweat Lactate Wearable Monitoring Device

Sweat Collection Group

Device: Commercial Sweat Collection Device (HELA)

Interventions

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.

Sweat Collection Group

High-Concentration Sweat Lactate Wearable Monitoring Device 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.

Wearable Device Monitoring Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kai Qu

CONTACT

+8613609117104; qukai001@xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: July 21, 2026

Record last verified: 2026-07