Impact of Fever Prevention in Brain Injured Patients "INTREPID"

Recruiting

Phase N/A Results N/A

Trial Description

This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo fever prevention using a targeted temperature management system and half of the subjects will be treated for fever should it develop.

Detailed Description

Multiple studies demonstrate that fever / elevated temperature is associated with poor outcomes in brain injured patients; however, there are no conclusive studies that demonstrate that fever prevention/controlled normothermia is associated with better outcomes. This study will be conducted to assess the impact of advanced temperature control to prevent fever in brain injured patients. The fever prevention group will use the Arctic Sun Temperature Management System and will be compared to standard care patients in whom fever may spontaneously develop. If fever develops in a patient in the standard care group, they will be treated with standard fever care measures according to a step-wise algorithm, consisting primarily of intermittent antipyretics (e.g., acetaminophen) and cooling blankets and, when necessary, advanced targeted temperature management devices.

Conditions

Interventions

  • Standard Care Behavioral
    Intervention Desc: No intervention to control temperature unless fever occurs
    ARM 1: Kind: Experimental
    Label: Standard Care
    Description: Standard care in which fever may spontaneously develop
  • Targeted Temperature Management Device
    Other Names: Arctic Sun 5000 Temperature Management System
    Intervention Desc: Prophylactic normothermia
    ARM 1: Kind: Experimental
    Label: Fever Prevention
    Description: Fever will be prevented using a surface targeted temperature management system

Outcomes

Type Measure Time Frame Safety Issue
Primary Fever Burden Up to 14 days
Secondary Primary Neurologic Outcome: Short-Term 3-months post injury
Secondary Other Neurologic Outcomes: NIH Stroke Scale Short-Term 3-months post injury
Secondary Other Neurologic Outcomes: Barthel Index Short-Term 3-months post injury
Secondary Other Neurologic Outcomes: Glasgow Outcome Scale Short-Term 3-months post injury
Secondary Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term 3-months post injury
Secondary Primary Neurologic Outcome: Mid-Term 6-months post injury
Secondary Other Neurologic Outcomes: NIH Stroke Scale Mid-Term 6-months post injury
Secondary Other Neurologic Outcomes: Barthel Index Mid-Term 6-months post injury
Secondary Other Neurologic Outcomes: Glasgow Outcome Scale Mid-Term 6-months post injury
Secondary Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term 6-months post injury
Secondary Primary Neurologic Outcome: Long-Term 12-months post injury
Secondary Adverse Events From date of randomization until hospital discharge, assessed up to 30 days
Secondary Infection Rate From date of randomization until hospital discharge, assessed up to 30 days
Secondary Incidence of Shivering Up to 14 days

Sponsors