External warming to help septic patients without fever

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines external warming as a treatment for afebrile sepsis. Participants are sedated, intubated adults meeting SEPSIS-3 criteria with a maximum temperature below 38.3°C. They are randomized to receive external warming or standard clinical care, and researchers will look at inflammatory blood proteins and overall prognosis. The study aims to understand if warming modulates the immune response and improves clinical condition in afebrile sepsis. Details on warming methods and escalation of care are governed by safety guidelines and manufacturer instructions.

Why it matters

Who can join: the full rules

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)

Where it's running

• Erasmus Medical Center
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Denyse Paalvast
• Email: d.paalvast@erasmusmc.nl
• Phone: +31639311643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.