| 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 | Â | Â | Â | Â | Â | Â |
Patient/next of kin information and consent | X | Â | Â | Â | Â | Â | Â |
Randomisation (within 8Â h after CSE onset) | Â | X | Â | Â | Â | Â | Â |
Standardised anticonvulsant treatment | Â | X | Â | Â | Â | Â | Â |
Brain imaging and other aetiological investigations | Â | X | Â | Â | Â | Â | Â |
Therapeutic hypothermia (in the intervention group) | Â | X | X | Â | Â | Â | Â |
Core temperature monitoring (every 4Â h) | Â | X | X | Â | Â | Â | Â |
Continuous EEG monitoring | Â | X | X | Â | Â | Â | Â |
30-min continuous EEG extract (centralised reading) | Â | X | X | Â | Â | Â | Â |
Clinical and laboratory monitoring | Â | X | X | X | X | Â | Â |
Serious adverse event reporting | Â | X | X | X | X | X | X |
Glasgow Outcome Scale (GOS) score evaluation | Â | Â | Â | Â | X | X | X1, 2 |
Standard EEG | Â | Â | Â | Â | Â | Â | X2 |
Brain MRI | Â | Â | Â | Â | Â | Â | X2 |
MMSE score | Â | Â | Â | Â | Â | Â | X2 |
FIM scale score | Â | Â | Â | Â | Â | Â | X2 |
Neurological evaluation | Â | Â | Â | Â | Â | Â | X2 |