INTREPID: Impact of Fever Prevention in Brain Injured Patients
Supported by: BARD
Principal Investigator at BMC: Anna Cervantes-Arslanian, MD
Primary Research Contact: Harshitha Shanbhogue, MBBS (617-638-7756)
Summary
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.
This is a randomized, controlled, multicenter, single-blind clinical investigation designed to assess fever burden and early, short- and long-term clinical outcomes of fever prevention (FP) using the Arctic Sun® 5000 Temperature Management System (test device) compared to standard fever care (control device(s)) in the treatment of moderate-to-severe brain injured patients.
Treatment Arms:
- Fever Prevention Group - Subjects randomized to the fever prevention group will be treated with the Arctic Sun® 5000 Temperature Management System in order to maintain normothermia (target temperature 37ºC). Normothermia will be maintained through day 14 of the study or until the subject is discharged from the ICU, whichever comes first.
- Standard Care Group - In subjects randomized to the standard care group, fever may or may not develop. Should fever develop, it will be managed according to a standard, escalating treatment algorithm. Subjects will be treated according to the protocol through day 14 of the study or until the subject is discharged from the ICU, whichever comes first.
Enrollment Criteria
Inclusion Criteria:
- Adult patients ≥21 and ≤80 years of age; and
- Admitted with a primary neurological diagnosis of ischemic stroke, ICH, or SAH; and
- Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2); and
- Meets disease-specific criteria.
|
DISEASE STATE |
STABILIZATION PERIOD (Enrollment Timeframe) |
INCLUSION CRITERIA |
EXCLUSION CRITERIA |
|---|---|---|---|
|
Ischemic Stroke |
No less than 3 hours but no more than 24 hours from ictus |
• Imaging confirmed dx • NIHSS ≥6 • IV tPA or approved IR mgt meets institutional guidelines |
• Symptomatic hemorrhagic transformation
|
|
ICH |
No less than 8 hours but no more than 24 hours from last known normal time Additionally, for patients on anti-coagulation therapy, only after 2 serial scans at least 4 hours apart show no further ICH expansion (>5cc) |
• Imaging confirmed diagnosis of primary ICH • NIHSS >6 on admission • GCS >5 on admission • ICH volume of 1-60 cc |
• ICH known to be secondary to neoplasm or trauma
|
|
SAH |
No less than 24 but no more than 48 hours after endovascular/surgical procedure and Within 72 hours of onset of symptoms |
• aSAH confirmed within 24 hrs of symptom onset • Adm imaging shows Fisher Grade 2, 3 or 4 • WFNS Grade II-V • Undergoes endovascular or surgical procedure • Neurological stability within 24-48 hrs of endovascular/ surgical procedure |
• SAH due to trauma or arteriovenous malformation •Glasgow Coma Scale ≤5 •WFNS Grade I
|
Exclusion Criteria:
- Fever (≥38°C) prior to study enrollment; or
- 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
- Has a pre-morbid condition with poor likelihood of survival to 6 months; or
- Has a pre-morbid mRS ≥3; or
- Diagnosed with brain death; or
- Is undergoing therapeutic hypothermia therapy; or
- Has sustained neurological injury felt to be catastrophic with little chance of recovery or is on comfort measures only; or
- 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
- Has poor skin integrity or poor tissue perfusion; or
- Participation in a concurrent investigational / interventional study (medical device or drug); or
- In the investigator’s opinion is likely to stay in the ICU ≤72 hours; or
- Is known to be pregnant, or has a positive pregnancy test (for women of childbearing age.
Status: Actively enrolling patients