Smart sensors aim to outsmart sepsis in ICU patients
NCT ID NCT07595848
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will test whether combining data from wearable sensors—measuring temperature, humidity, and sweat lactate—can predict the onset of sepsis in ICU patients. Researchers will monitor 360 adults at risk of sepsis for up to 48 hours. The goal is to use this data to train artificial intelligence models that could one day give early warnings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CPC12S Telemonitoring System, CPC Temperature/Humidity Sensor, IDRO Sweat Lactate Sensor
- What this could lead to
- If successful, this could lead to a wearable system that alerts doctors to sepsis hours earlier, potentially saving lives in intensive care.
- What could go wrong
- This is an early-stage study focused on data collection and model development, not a proven tool. The sensors may not reliably predict sepsis in real-world settings.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 360 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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