Temperature Control in Central Fever in the Neuro-ICU

Northwestern University

Status and phase: Completed; Phase 4

Conditions: Fever; Brain Hemorrhage

Treatments: Device: Gaymar Rapr-Round (external cooling blanket)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00751634

1507-009

Details and patient eligibility

About

There are few treatments for central fever (fever that is due to the central nervous system, as opposed to an infectious source). We hypothesize that an externally applied cooling blanket will reduce temperature in neurologically ill patients with central fever.

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Two or more days with core temperature ≥ 100.4F
• Approval of the patient's primary attending physician
• Need for core temperature measurement independent of the study.
• Admission to the Neuro-ICU [intensive care unit] for an underlying condition

Exclusion criteria

• Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS [central nervous system] infection or urinary tract infection.
• Expected death from any cause
• Known sensitivity to the device
• History of pre-admission hypothalamic dysfunction or known temperature dysregulation
• Use of 2 or more vasopressor medications, since this may make a local skin reaction to the device more likely
• Hemodynamic instability

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

A

Experimental group

Description:

Application of the Gaymar Rapr-Round device per approved use

Treatment:

Device: Gaymar Rapr-Round (external cooling blanket)