Impact of Fever Prevention in Brain Injured Patients (INTREPID)

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

* Adult patients ><=18 and <<=85 years of age (for patients >80 and <<=85 years of age, the qualifying mRS must be <= 0)
* Admitted with a primary neurological diagnosis of ischemic stroke (AIS), intracerebral hemorrhage (ICH), or subarachnoid hemorrhage (SAH)
* Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)
* Disease-specific criteria:
For AIS patients:
- imaging confirmed diagnosis
- NIHSS ><= 6 at the time of consideration of enrollment
For ICH patients:
- imaging confirmed diagnosis
- NIHSS ><= 6 at the time of consideration of enrollment
- GCS ><= 5 at the time of consideration of enrollment
- ICH volume of 1-60 cc
For SAH patients:
- aneurysmal SAH confirmed within 24 hrs of symptom onset
- admission imaging shows Fisher Grade 2, 3 or 4
- WFNS Grade II-IV
- neurological stability within 6-48 hrs of endovascular or surgical procedure (if performed)

Exclusion Criteria

* Fever (>= 38°C) for more than one hour prior to study enrollment
* 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
* Has a pre-morbid condition that in the opinion of the investigator suggests poor likelihood of survival to 6 months
* Is undergoing therapeutic hypothermia therapy
* Has sustained neurological injury felt to be catastrophic with little chance of recovery or is on comfort measures only
* Has a skin condition in which the use of the ArcticGel Pads is contraindicated
* Participation in a concurrent interventional study
* In the investigator*s opinion is likely to stay in the ICU <= 72 hours
* Is known to be pregnant
* fever (>= 38°C) at time of study enrollment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome endpoint is the daily average fever burden (°C-hour)<br /><br>between randomization and Day 14 (336 hours) or ICU exit, whichever comes<br /><br>first.<br /><br>The key secondary outcome endpoint (to which the study was powered) is the<br /><br>level of functional independence at 90 days post-injury (3-month) follow-up<br /><br>based on the modified Rankin Scale. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Neurologic outcome measures<br /><br>- Modified Rankin Scale measured at 6- and 12-months<br /><br>- National Institutes of Health Stroke Scale measured at 3- and 6-months<br /><br>- Barthel Index measured at 3- and 6-months<br /><br>- Glasgow Outcome Scale Extended measured at 3- and 6-months<br /><br>- Montreal Cognitive Assessment measured at 3- and 6-months<br /><br><br /><br>* Intensive Care Unit length of stay<br /><br>* ICU Delirium<br /><br>* Use of mechanical ventilation<br /><br>* Hospital length of stay<br /><br>* Mortality [7-day (or hospital discharge), 3-, 6-, and 12-month]</p><br>