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

Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
Study ID
NCT07716371
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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 Details

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.

Key Dates

First listed
Jul 21, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2029

Study Design

Enrollment
86 participants (estimated)

Arms

  • Arm: Wearable Device Monitoring Group
  • Arm: Sweat Collection Group

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) ]

Central Contacts

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