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NCT Number: NCT07831057

Temperature Optimization in Afebrile Septic PatienTs

The goal of this interventional study is to learn if external warming works to treat patients with a serious systemic infection (i.e. sepsis) that do not have fever. These patients have a higher risk of dying than patients with fever. It is possible that these patients might benefit from artificial external warming with the means to increase body temperature. It is unknown what the mechanism is, but it might be related to the immune system and how the body manages blood pressure and perfusion.

The main questions to answer are:

* Does external warming of the body influence certain inflammatory proteins in the blood? * Does external warming of the body influence prognosis and/or clinical condition? Researchers will compare external warming to standard clinical practice to see if external warming works to treat sepsis without fever.

Participants will:

- receive treatment with external warming or treatment according to clinical practice

Recruiting

Interested in participating?

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Key information

Conditions

Sepsis Body Temperature Changes Heat Stress Disorders Hyperthermia Hypothermia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Systemic Inflammatory Response Syndrome Temperature Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location status: Recruiting

Location contact

Denyse Paalvast

CONTACT

[email protected]

+31639311643

Denyse Paalvast

SUB_INVESTIGATOR

Matthew B.A. Harmon

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

External warming

Other

External Warming with the Arctic Sun 5000

Other names: Therapeutic Hyperthermia

Primary outcomes

  1. Proteomics

    Time frame: From enrollment until 48 hours after enrollment

    Delta proteomics pathway analysis between baseline and after 48 hours of enrollment.

Secondary outcomes

  1. Mortality

    Time frame: 30 days

    The effect of external warming of afebrile septic patients on mortality

  2. Organ failure

    Time frame: until end of ICU stay, approximately 30 days

    To assess the effect of external warming of afebrile septic patients on organ failure.

  3. Length of ICU stay

    Time frame: until end of ICU stay, approximately 30 days

    To assess the effect of external warming of afebrile septic patients on length of ICU-stay

  4. Nosocomial infections

    Time frame: until end of ICU stay, approximately 30 days

    To assess the effect of external warming of afebrile septic patients on nosocomial infections.

  5. Length of hospital stay

    Time frame: until discharge, approximately 30 days until 3 months

    To assess the effect of external warming of afebrile septic patients on length of ICU-stay

  6. Microcirculation

    Time frame: From enrollment until 48 hours after enrollment

    To assess the impact of therapeutic hyperthermia in afebrile septic patients on microcirculation measured sublingually

  7. Hemodynamics

    Time frame: From enrollment until 48 hours after enrollment

    To assess the impact of external warming in afebrile septic patients on hemodynamics

  8. Mitochondrial oxygen tension

    Time frame: From enrollment until 48 hours after enrollment

    To assess the impact of external warming in afebrile septic patients on mitochondrial oxygen tension

Study contacts

Contact information is provided by the study sponsor or research team.

Denyse Paalvast

CONTACT

[email protected]

+31639311643

Matthew B.A. Harmon

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Matt Harmon

Other

Collaborators

  • BD Technologies, Research Triangle Park, NC

Registry information

Acronym: TOAST

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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