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Can warming the body help sepsis patients who cannot make a fever?

NCT ID NCT07831057

NEW Symptom relief Sponsor: Matt Harmon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Sepsis patients without fever face a higher risk of dying, and researchers want to know if raising their body temperature helps. This trial assigns 50 sedated, intubated sepsis patients to receive external warming with the Arctic Sun 5000 device or standard care. The team measures changes in inflammatory proteins after 48 hours and tracks survival, organ failure, and ICU stay length.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
External warming with the Arctic Sun 5000 device
What this could lead to
If warming helps, it could offer a simple, device-based way to support sepsis patients who do not mount a fever, potentially improving survival and organ function.
What could go wrong
This is a small, early study of 50 sedated, intubated patients, so results may not apply broadly. Warming could also stress the body or fail to change the immune response.

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 50 people

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

Started

Jul 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: * Sepsis according to the SEPSIS-3 definition * Sedated and intubated * Highest temperature \< 38,3 degrees Celsius Exclusion Criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: * Patients with immunologic diseases: * human immunodeficiency virus * neutropenia * history of chronic infection with hepatitis B or C virus Patients using immune suppressing medications: * treatment with corticosteroids at a dose of \> 300 mg/day hydrocortisone or equivalent at the time of enrollment; * Tacrolimus * Mycophenolate mofetil * Ciclofosfamide Patients with a contraindication for therapeutic hyperthermia: * cardiac arrest * acute ischemic stroke * acute coronary syndrome * traumatic brain injury * spinal cord injury * sickle cell disease * multiple sclerosis * Pregnancy * Moribund patients (expected death within 48 hours) * Contraindications to forced air warming devices per manufacture instructions (i.e. ischemic limbs)

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Conditions

The condition(s) this trial relates to.

Hyperthermia Hypothermia infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis Temperature

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Erasmus Medical Center

    RECRUITING

    Rotterdam, South Holland, 3015GD, Netherlands

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