Integration of Wearable Sensor Devices Into a Single System to Predict the Onset of Sepsis
Starting soon · Not applicable
Conditions studied: Sepsis
In brief
The purpose of this clinical investigation is to evaluate the integration of data from the CPC12S telemonitoring device, the CPC temperature/humidity sensor, and the IDRO sweat lactate sensor into a single system for the prediction of sepsis onset in ICU patients at risk of developing sepsis. Patients will be monitored for up to 48 hours, and the collected physiological and biomarker data will be used to support the development of artificial intelligence and machine learning models for sepsis prediction.
Key facts
- Study ID
- NCT07595848
- Run by
- Check Point R & D Ltd
- People needed
- 360
- Starts
- 2026-07-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-05-19
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients aged 18 years or older.
- Patients admitted to the intensive care unit who are at risk of developing sepsis.
- Patients with one or more relevant risk factors for sepsis, including pre-existing medical conditions, invasive medical devices, recent procedures or conditions, active infections, clinical risk factors, or prolonged ICU/hospital stay.
- Signed informed consent.Exclusion Criteria:
- Inability or unwillingness to provide informed consent or comply with study requirements.
- ICU stay shorter than 6 hours.
- Damaged tattoos, bare skin, recent scar tissue, inflammation, infection, skin barrier alteration, serous or bloody discharge, or metal plates/nails at the area where the Macroduct Advanced system and IDRO device will be placed.
- Patients admitted to the ICU with already diagnosed sepsis.
- Patients participating in other clinical studies.
- Moribund patients or patients with very short life expectancy.
- Patients with do-not-resuscitate status at admission.
- Patients with implanted devices such as an implanted defibrillator, implanted neurostimulator, implanted pacemaker, or implanted ECG monitor.
- Patients in whom short-term interference between the Macroduct device and clinical monitoring cannot be accepted.
- Patients with a history of epilepsy or seizures.
- Pregnant patients or patients who may be pregnant.
- Patients with previous adverse reactions to electrotherapy.
- Patients who present adverse reactions during the first sampling with the Macroduct device.
- Patients for whom the procedure is contraindicated for medical reasons according to the physician's decision.
- Patients with known sensitivity or allergy to pilocarpine nitrate, or any medical contraindication to pilocarpine administration.
- Patients in environments with flammable anesthetics or oxygen-enriched environments.
Full record on ClinicalTrials.gov
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