We sought to evaluate the safety and feasibility of mild therapeutic hypothermia using
an endovascular temperature management system in awake acute ischemic stroke patients.
The Intravascular Cooling in the Treatment of Stroke (ICTuS) study was an uncontrolled,
multicenter development and feasibility study of conscious patients (n = 18) presenting
within 12 hours of onset of an acute ischemic stroke at 5 clinical sites in the United
States. Enrolled patients were to undergo core temperature management using an endovascular
cooling system to induce and maintain mild, therapeutic hypothermia (target temperature
of 33.0°C) for a period of either 12 or 24 hours, followed by controlled rewarming
to 36.5°C over the subsequent 12-hour period. Nine patients underwent 12 hours of
cooling followed by 12 hours of controlled rewarming, and 6 patients underwent 24
hours of cooling followed by 12 hours of controlled rewarming. Three patients underwent
<1.5 hours of hypothermia due to clinical or technical issues. We also developed an
antishivering regimen using buspirone and meperidine administered prophylactically
to suppress shivering. The endovascular cooling catheter was well tolerated, with
acceptable adverse event rates. Increasing the duration of hypothermia administration
from 12 hours to 24 hours did not appear to increase the incidence or severity of
adverse effects. Endovascular cooling with a proactive antishivering regimen can be
accomplished in awake stroke patients. Further studies are needed to establish the
safety and efficacy of this approach.
Key words
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Article info
Publication history
Accepted:
December 28,
2004
Received:
November 17,
2004
Identification
DOI: https://doi.org/10.1016/j.jstrokecerebrovasdis.2005.01.001
Copyright
© 2005 National Stroke Association. Published by Elsevier Inc. All rights reserved.
