Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT04961151
Eligibility Criteria:
Inclusion Criteria:
* Patients above the age of 18 years old.
* Patients with sepsis diagnosed within 48 hours of enrollment. For the purpose of this protocol, sepsis onset is defined as administration of intravenous antibiotics in a patient that the treating critical care physician feels is ill from sepsis.
* All qualifying patients must have a sequential organ failure assessment (SOFA) score of 2 or greater at the time of enrollment.
* Patients requiring mechanical ventilation with an expected duration of mechanical ventilation of \>= 2 days.
* Patient maximum baseline documented temperature (within previous 24 hours) \< 38.3°C.
Exclusion Criteria:
* Patients without legally authorized representative able to provide informed consent.
* Patients with contraindication to core warming using an esophageal core warming device, surface warming using conductive heat transfer, and forced air warmer.
* Patients known to be pregnant.
* Patients with \<40 kg of body mass.
* Patients with comfort care only status.
* Patients with contraindications to hyperthermia treatment (acute stroke, acute traumatic brain injury, acute spinal cord injury, post-cardiac arrest, multiple sclerosis, or sickle cell disease).
* Expected continuous dialysis within 48 hours after enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04961151
Study Brief:
Protocol Section:
NCT04961151