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. 2021 Feb 24;10(2):e22511. doi: 10.2196/22511

Table 1.

Trial visits summary.

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.