NCT02996266

Impact of Fever Prevention in Brain Injured Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 686 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

• Fever
• Ischemic Stroke
• Intracerebral Hemorrhage
• Subarachnoid Hemorrhage

Interventions

Type	Name	Description
DEVICE	Targeted Temperature Management	Prophylactic normothermia
OTHER	Standard Care	No intervention to control temperature unless fever occurs

Timeline

• Start date: 2017-01-01
• Primary completion: 2022-05-12
• Completion: 2022-05-12
• First posted: 2016-12-19
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

40 sites across 6 countries: United States, Australia, Austria, Germany, South Korea, Switzerland