NCT07831057 Temperature Optimization in Afebrile Septic PatienTs
| NCT ID | NCT07831057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Matt Harmon |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-07-17 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-07-17 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07831057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07831057 currently recruiting?
Yes, NCT07831057 is actively recruiting participants. Contact the research team at d.paalvast@erasmusmc.nl for enrollment information.
Where is the NCT07831057 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT07831057 clinical trial?
NCT07831057 is sponsored by Matt Harmon. The trial plans to enroll 50 participants.