Temperature Control in Central Fever in the Neuro-ICU

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fever Brain Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Application of the Gaymar Rapr-Round device per approved use

Group Type EXPERIMENTAL

Gaymar Rapr-Round (external cooling blanket)

Intervention Type DEVICE

Application of the device per its approved labeling

Interventions

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Gaymar Rapr-Round (external cooling blanket)

Application of the device per its approved labeling

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No