Smart sensors aim to outsmart sepsis in ICU patients

NCT ID NCT07595848

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Recruiting now
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By invitation only
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
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When the status isn't known

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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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 100 years

Sex

Anyone

Healthy volunteers

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

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

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