SepsisTOASTNCT07831057
Temperature Optimization in Afebrile Septic PatienTs
A study testing External Warming in people with Sepsis and Temperature, run by Matt Harmon at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Temperature
- What is being tested?
- External Warming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Jul 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sepsis according to the SEPSIS-3 definition
- Sedated and intubated
- Highest temperature < 38,3 degrees Celsius
Who cannot join
- 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:
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Matthew B.A. Harmon contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Denyse Paalvast, +31639311643, d.paalvast@erasmusmc.nl
Matthew B.A. Harmon, m.harmon@erasmusmc.nl
About this study
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:
Read more
- 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
- Conditions
- Sepsis, Temperature
- Being tested
- External Warming
- Keywords
- Sepsis, Temperature Optimization, Temperature Management, Afebrile, Hypothermic, TOAST, Septic Patients, External Warming, Therapeutic Hyperthermia
- Medical subject headings
- Sepsis, Hypothermia, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External WarmingOther
Also called Therapeutic Hyperthermia
External Warming with the Arctic Sun 5000
| Study group | Role | What they receive |
|---|---|---|
| External Warming | Experimental | Intervention with External Warming Receives: Other: External Warming |
| Control | No intervention | Control group according to standard clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomics
Delta proteomics pathway analysis between baseline and after 48 hours of enrollment.
Measured: From enrollment until 48 hours after enrollment
Secondary outcomes (8)
Mortality
The effect of external warming of afebrile septic patients on mortality
Measured: 30 days
Organ failure
To assess the effect of external warming of afebrile septic patients on organ failure.
Measured: until end of ICU stay, approximately 30 days
Length of ICU stay
To assess the effect of external warming of afebrile septic patients on length of ICU-stay
Measured: until end of ICU stay, approximately 30 days
Nosocomial infections
To assess the effect of external warming of afebrile septic patients on nosocomial infections.
Measured: until end of ICU stay, approximately 30 days
Length of hospital stay
To assess the effect of external warming of afebrile septic patients on length of ICU-stay
Measured: until discharge, approximately 30 days until 3 months
Microcirculation
To assess the impact of therapeutic hyperthermia in afebrile septic patients on microcirculation measured sublingually
Measured: From enrollment until 48 hours after enrollment
Hemodynamics
To assess the impact of external warming in afebrile septic patients on hemodynamics
Measured: From enrollment until 48 hours after enrollment
Mitochondrial oxygen tension
To assess the impact of external warming in afebrile septic patients on mitochondrial oxygen tension
Measured: From enrollment until 48 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start17 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matt Harmon
- Sponsor type
- University, hospital or other
- Collaborators
- BD Technologies, Research Triangle Park, NC
- Responsible party
- Sponsor-investigator, Matt Harmon, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831057
- Sponsor's protocol ID
- 12627
- Other IDs
- NL-010467, NL-OMON58549
- Acronym
- TOAST
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during this study that underlie the results reported in publications (including participant-level efficacy and safety data), together with the corresponding data dictionary, will be made available. Data will be prepared to minimize the risk of participant identification in accordance with applicable laws, regulations, institutional policies, and informed consent provisions. Informed consent form will not be shared as it is in Dutch.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Optimization in Afebrile Septic PatienTs
- ClinicalTrials.gov ID
- NCT07831057
- Acronym / sponsor ID
- TOAST / 12627
- Conditions
- Sepsis, Temperature
- Keywords
- Sepsis, Temperature Optimization, Temperature Management, Afebrile, Hypothermic, TOAST, Septic Patients, External Warming
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Matt HarmonUniversity, hospital or other
- Collaborators
- BD Technologies, Research Triangle Park, NC
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Warming | Experimental | Other: External WarmingIntervention with External Warming |
| Control | No intervention | –Control group according to standard clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sepsis according to the SEPSIS-3 definition
- Sedated and intubated
- Highest temperature < 38,3 degrees Celsius
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External WarmingAlso: Therapeutic HyperthermiaExternal Warming with the Arctic Sun 5000 | Other | External Warming |
Primary outcome
Proteomics
Time frame: From enrollment until 48 hours after enrollment
Delta proteomics pathway analysis between baseline and after 48 hours of enrollment.
8 secondary outcomes
Mortality
Time frame: 30 days
Organ failure
Time frame: until end of ICU stay, approximately 30 days
Length of ICU stay
Time frame: until end of ICU stay, approximately 30 days
Nosocomial infections
Time frame: until end of ICU stay, approximately 30 days
Length of hospital stay
Time frame: until discharge, approximately 30 days until 3 months
Microcirculation
Time frame: From enrollment until 48 hours after enrollment
Hemodynamics
Time frame: From enrollment until 48 hours after enrollment
Mitochondrial oxygen tension
Time frame: From enrollment until 48 hours after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during this study that underlie the results reported in publications (including participant-level efficacy and safety data), together with the corresponding data dictionary, will be made available. Data will be prepared to minimize the risk of participant identification in accordance with applicable laws, regulations, institutional policies, and informed consent provisions. Informed consent form will not be shared as it is in Dutch.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew B.A. Harmon contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Warming in people with Sepsis and Temperature, run by Matt Harmon at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denyse Paalvast (+31639311643, d.paalvast@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomics (time frame: From enrollment until 48 hours after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.