Table 1.
Time point | Enrollment | Allocation | Postallocation | Close-out | |||||||
|
−t1 | 0 | t0 | 15 min | 12 h | Day 1 | Days 2,3,4,7 | Day 15 | Days 15-90 | Day 90 | |
Enrollment | |||||||||||
|
Eligibility screen | ✓a | —b | — | — | — | — | — | — | — | — |
|
Informed consent | ✓ | — | — | — | — | — | — | — | — | — |
|
Allocation | — | ✓ | — | — | — | — | — | — | — | — |
Interventions | |||||||||||
|
Valproate dosage | — | — | ✓ | ✓ | ✓ | — | — | — | — | — |
Assessments | |||||||||||
|
Clinical assessment | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | — | — |
|
CAM-ICUc, GCSd, and RASSe | — | — | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | — | — |
|
Etiological investigation | — | — | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | — | — |
|
Standard EEGf | — | — | — | — | — | ✓ | ✓ | ✓ | — | — |
|
SOFAg | — | — | ✓ | — | ✓ | ✓ | ✓ | ✓ | — | — |
|
SAPS-IIh | — | — | — | — | — | ✓ | — | — | — | — |
|
FABi, MMSEj, GOSEk, and SF-36l | — | — | — | — | — | — | — | — | — | ✓ |
|
Valproate adverse effects reporting | — | — | ✓ | — | ✓ | ✓ | ✓ | ✓ | — | — |
|
Primary outcome | — | — | — | — | — | — | — | ✓ | — | — |
|
Secondary outcome | — | — | ✓ | — | ✓ | — | — | — | — | — |
|
End of trial criteria | — | — | — | — | — | — | — | — | — | — |
a✓: visit is scheduled.
bAbsence of visits.
cCAM-ICU: Confusion Assessment Method for the Intensive Care Unit.
dGCS: Glasgow Coma Scale.
eRASS: Richmond Agitation-Sedation Scale.
fEEG: electroencephalogram.
gSOFA: sepsis-related organ failure assessment.
hSAPS-II: Simplified Acute Physiology Score.
iFAB: Frontal Assessment Battery.
jMMSE: Mini-Mental State Examination.
kGOSE: Glasgow Outcome Scale-Extended.
lSF-36: Short Form-36.