The purpose of this study is to determine if systemic cooling to a target temperature of 34 to 35°C, started within 6 hours of symptom onset and maintained for 12 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
In patients randomised to therapeutic hypothermia, induction of cooling will be started by infusion of 4°C isotone saline or Ringer's lactate administered over a period of 30 to 60 minutes. A body temperature between 34.0 and 35.0°C will be targeted. Body temperature will be monitored through bladder or rectal thermal probes, and cooling procedures will be adapted to keep body temperature as close as possible to the target. Maintenance of body temperature in the target range will be performed with a surface or endovascular cooling device. After a cooling period of 24h, controlled rewarming to 36°C with a rate of 0.2°C/h will be started. After 36°C have been reached, the device will be disconnected.
anti-shivering treatment
Department of Neurology, University Hospital Erlangen
Erlangen, Germany
modified Rankin scale
Analysed with ordinal logistic regression and expressed as a common odds ratio.
Time frame: 3 months
Mortality
Time frame: 3 months
Neurological outcome
NIHSS; World Health Organization Disability Assessment Schedule (WHODAS) 2.0
Time frame: 3 months
Quality of life
EuroQoL 5-dimensions 5-level questionnaire
Time frame: 3 months
Cerebral infarct size
Evaluated on CT or MRI imaging
Time frame: 48±24 hours
Safety of systemic cooling
Number of adverse events and severe adverse events related to the procedure of systemic cooling including induction, maintenance of hypothermia, rewarming, or the administration of anti-shivering medication (pethidine and buspirone) within the first 36h of enrollment. Number of adverse events and severe adverse events until outcome assessment at day 91.
Time frame: Enrollment - day 91
Tolerability of systemic cooling
Timing and dose of anti-shivering medication. Bedside shivering assessment scale (BSAS).
Time frame: 36 hours
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anti-shivering treatment