Skip to main content
Annals of Intensive Care

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
Back to article page