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Table 1 HYBERNATUS trial flow chart

From: Neuroprotective effect of therapeutic hypothermia versus standard care alone after convulsive status epilepticus: protocol of the multicentre randomised controlled trial HYBERNATUS

  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
  1. 1By phone interview in all cases
  2. 2Neurologist visit, if feasible