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

NCT07716371 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2026-07-21

No results posted yet for this 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.

Conditions

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

Interventions

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.

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.

Sponsors & Collaborators

  • Second Affiliated Hospital of Xi'an Jiaotong University

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-10-01
Completion
2029-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07716371 on ClinicalTrials.gov