Skip to main content

Table 1 Visit schedule with all corresponding assessments

From: Treatment of established status epilepticus in the elderly - a study protocol for a prospective multicenter double-blind comparative effectiveness trial (ToSEE)

Visit Screening V1 V2a
  Initiation of infusion     During 24 h after T0 Further Hospital stay
T0 T15 T30 T60
Time   0 15 min 30 min 60 min 24 h  
Eligibility criteria X       
Informed consentb X       
Randomization X       
Medical/Medication History X       
CP-Monitoringc   Continuously   
EEGd X4 Continuously4   
Blood analysise X     X   
VPA or LEV infusion   X      
GCSf X   X X X   X
Neurological exam X     X   X
mRS/BIg Xh       X
Home care Xh       Xi
Adverse events   X  
Recurrence seizures/SE   Recorded any time until discharge  
Clinical dataj   X  
  1. VPA Valproate, LEV Levetiracetam, (NC)SE (nonconvulsive) status epilepticus
  2. aFollow-up-visit, at day of discharge or day 30
  3. bby legal or authorised representative or according to §41 AMG (1)
  4. ccardiopulmonary monitoring
  5. delectroencephalography, only in patients with NCSE
  6. ecomplete blood count, liver, kidney function, sodium, level of VPA, level of LEV
  7. fGlasgow Coma Scale
  8. gmodified Rankin Scale/Barthel Index
  9. hpremorbid state by patient (retrospective) or relatives
  10. i after hospital stay (if applicable)
  11. jclinical data about the hospital stay, i.e. infections with i.v. antibiotics, special medications, initiation of invasive/noninvasive ventilation, recorded on day of discharge/day 30