Impact of Fever Prevention in Brain Injured Patients (INTREPID)

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 685

Inclusion Criteria

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

Exclusion Criteria

1. Fever (=38.0°C) for more than one hour or one instance prior to study enrollment; or
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; or
3. Has a pre-morbid condition with poor likelihood of survival to 6 months; or
4. Has a pre-morbid mRS =3 for subjects 18 – 80 years of age or =1 for subjects =81 years of age; or
5. Diagnosed with brain death; or
6. Is undergoing therapeutic hypothermia therapy; or
7. Has sustained neurological injury felt to be catastrophic with little chance of recovery or is on comfort measures only; or
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); or
9. Has poor skin integrity or poor tissue perfusion; or
10. Participation in a concurrent investigational / interventional study (medical device or drug); or
11. In the investigator’s opinion is likely to stay in the ICU =72 hours; or
12. Is known to be pregnant, or has a positive pregnancy test (for women of childbearing age.
13. Fever (=38.0°C) at time of study enrollment.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: <br>The primary outcome endpoint is the daily average fever burden (°C-hour) between randomization and Day 14 (336 hours) or ICU exit, whichever comes first. <br>Safety:<br>The primary safety endpoints will include adverse events, major adverse events, incidence of infection, and incidence of shivering<br>

Secondary Outcome Measures

Name	Time	Method
The key secondary outcome endpoint is the level of functional independence at 90 days post-injury (3-month) follow-up based on the modified Rankin Scale. <br>Other secondary endpoints include <br>- additional neurologic outcomes measured at varying time points<br>- Mortality<br>- ICU Delirium<br>- ICU and hospital length of stay<br>- Use of mechanical ventilation<br><br>