Impact of Fever Prevention in Brain-Injured Patients (INTREPID): Study Protocol for a Randomized Controlled Trial.

Autor: Greer DM; Department of Neurology, Boston University School of Medicine, Boston Medical Center, Collamore 3, Suite 338, 72 East Concord Street, Boston, MA, USA. dgreer@bu.edu., Ritter J; Becton Dickenson & Company, Franklin Lakes, NJ, USA., Helbok R; Department of Neurology, Neurology Medical University of Innsbruck, Anichstreet 65, 6020, Innsbruck, Austria., Badjatia N; Program in Trauma, Department of Neurology, University of Maryland School of Medicine, 655 West Baltimore Street, Baltimore, MD, USA., Ko SB; Department of Neurology, Boston University School of Medicine, Boston Medical Center, Collamore 3, Suite 338, 72 East Concord Street, Boston, MA, USA., Guanci M; Neurocritical Care Unit, Massachusetts General Hospital, Lunder Building 6th Floor, 55 Fruit Street, Boston, MA, USA., Sheth KN; Department of Neurology, Yale University School of Medicine, 15 York Street, LCI 1003, New Haven, CT, USA.
Jazyk: angličtina
Zdroj: Neurocritical care [Neurocrit Care] 2021 Oct; Vol. 35 (2), pp. 577-589. Date of Electronic Publication: 2021 Mar 24.
DOI: 10.1007/s12028-021-01208-1
Abstrakt: Background: Multiple studies demonstrate that fever/elevated temperature is associated with poor outcomes in patients with vascular brain injury; however, there are no conclusive studies that demonstrate that fever prevention/controlled normothermia is associated with better outcomes. The primary objective of the INTREPID (Impact of Fever Prevention in Brain-Injured Patients) trial is to test the hypothesis that fever prevention is superior to standard temperature management in patients with acute vascular brain injury.
Methods: INTREPID is a prospective randomized open blinded endpoint study of fever prevention versus usual care in patients with ischemic or hemorrhagic stroke. The fever prevention intervention utilizes the Arctic Sun System and will be compared to standard care patients in whom fever may spontaneously develop. Ischemic stroke, intracerebral hemorrhage or subarachnoid hemorrhage patients will be included within disease-specific time-windows. Both awake and sedated patients will be included, and treatment is initiated immediately upon enrollment. Eligible patients are expected to require intensive care for at least 72 h post-injury, will not be deemed unlikely to survive without severe disability, and will be treated for up to 14 days, or until deemed ready for discharge from the ICU, whichever comes first. Fifty sites in the USA and worldwide will participate, with a target enrollment of 1176 patients (1000 evaluable). The target temperature is 37.0 °C. The primary efficacy outcome is the total fever burden by °C-h, defined as the area under the temperature curve above 37.9 °C. The primary secondary outcome, on which the sample size is based, is the modified Rankin Scale Score at 3 months. All efficacy analyses including the primary and key secondary endpoints will be primarily based on an intention-to-treat population. Analysis of the as-treated and per protocol populations will also be performed on the primary and key secondary endpoints as sensitivity analyses.
Discussion: The INTREPID trial will provide the first results of the impact of a pivotal fever prevention intervention in patients with acute stroke ( www.clinicaltrials.gov ; NCT02996266; registered prospectively 05DEC2016).
(© 2021. Springer Science+Business Media, LLC, part of Springer Nature and Neurocritical Care Society.)
Databáze: MEDLINE
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