Impact of Fever Prevention in Brain Injured Patients

Not Applicable

Terminated

• Conditions: Fever; Ischemic Stroke; Intracerebral Hemorrhage; Subarachnoid Hemorrhage

• Registration Number: NCT02996266
• Lead Sponsor: C. R. Bard

Brief 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.

Study Timeline

• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-19
• Study Start: 2017-01
• Primary Completion: 2022-05-12
• Study Completion: 2022-05-12
• Results First Submitted: 2023-07-10
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-25
• Last Update Submitted: 2023-08-25
• Results First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 686

Inclusion Criteria

1. Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage
2. Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)
3. Meets disease-specific criteria

Exclusion Criteria

1. Fever (≥38°C) prior to study enrollment
2. Pre-existing neurological, psychiatric, or other condition that would confound neurological assessment or would make it difficult to accurately assess neurologic and/or functional outcome
3. Has a pre-morbid condition with poor likelihood of survival to 6 months
4. Has a pre-morbid mRS ≥3
5. Diagnosed with brain death
6. Is undergoing therapeutic hypothermia therapy
7. Has sustained neurological injury felt to be catastrophic with little chance of recovery
8. Has a skin condition in which the use of the ArcticGel Pads is contraindicated (i.e., skin that has signs of ulceration, burns, hives, or rash)
9. Has poor skin integrity or poor tissue perfusion
10. Participation in a concurrent investigational / interventional study (medical device or drug)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fever Burden	Up to 14 days	Daily average fever burden (°C-hour)

Secondary Outcome Measures

Name	Time	Method
Other Neurologic Outcomes: Glasgow Outcome Scale Extended Short-Term	3-months post injury	Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.
Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term	3-months post injury	Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.
Other Neurologic Outcomes: Barthel Index Short-Term	3-months post injury	Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.
Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term	6-months post injury	Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.
Other Neurologic Outcomes: NIH Stroke Scale Short-Term	3-months post injury	NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.
Other Neurologic Outcomes: Glasgow Outcome Scale Extended Mid-Term	6-months post injury	Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.
Other Neurologic Outcomes: NIH Stroke Scale Mid-Term	6-months post injury	NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.
Primary Neurologic Outcome: Modified Rankin Scale Long-Term	12-months post injury	Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
Major Adverse Events	From date of randomization until end of study, assessed up to 12 months	MAEs defined as one of the following: pneumonia, sepsis, malignant cerebral edema, death
Number of Subjects With Shivering	Up to 14 days	Shivering greater than or equal to 1 on the Bedside Shivering Assessment Scale (BSAS). BSAS scores range from 0-3 with 0 indicating no shivering noted and 3 indicating severe shivering involving gross movements of the trunk and upper and lower extremities.
Primary Neurologic Outcome: Modified Rankin Scale Short-Term	3-months post injury	Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
Primary Neurologic Outcome: Modified Rankin Scale Mid-Term	6-months post injury	Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
Adverse Events	From date of randomization until hospital discharge, assessed up to 30 days	An untoward medical occurrence, unintended disease or injury, or unanticipated complication
Other Neurologic Outcomes: Barthel Index Mid-Term	6-months post injury	Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.
Number of Participants With Infection	From date of randomization until hospital discharge, assessed up to 30 days	Healthcare associated infection

Trial Locations

Locations (40)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Stanford University Hospital; 🇺🇸 Palo Alto, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Swedish Medical Center; 🇺🇸 Englewood, Colorado, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Rush University; 🇺🇸 Chicago, Illinois, United States

Norton Neuroscience Institute; 🇺🇸 Louisville, Kentucky, United States

Tulane Medical Center; 🇺🇸 New Orleans, Louisiana, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

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