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Temperature Optimization in Afebrile Septic PatienTs

RecruitingNAAges 18 Years - anyAllMatt Harmon
NCT07831057 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • External Warming
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Where

1 site
Erasmus Medical Center
Rotterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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