Inclusion | Day 0 | Day 1 |
Day 2 Day 7 Day 14 Day 28 | ICU discharge | Hospital discharge | Day 90 (±7 days) | |
---|---|---|---|---|---|---|---|
Eligibility: check inclusion and non-inclusion criteria | X | ||||||
Patient/next of kin information and consent | X | ||||||
Randomisation (within 8 h after CSE onset) | X | ||||||
Standardised anticonvulsant treatment | X | ||||||
Brain imaging and other aetiological investigations | X | ||||||
Therapeutic hypothermia (in the intervention group) | X | X | |||||
Core temperature monitoring (every 4 h) | X | X | |||||
Continuous EEG monitoring | X | X | |||||
30-min continuous EEG extract (centralised reading) | X | X | |||||
Clinical and laboratory monitoring | X | X | X | X | |||
Serious adverse event reporting | X | X | X | X | X | X | |
Glasgow Outcome Scale (GOS) score evaluation | X | X | X1, 2 | ||||
Standard EEG | X2 | ||||||
Brain MRI | X2 | ||||||
MMSE score | X2 | ||||||
FIM scale score | X2 | ||||||
Neurological evaluation | X2 |