Skip to main content

Table 2 Secondary endpoints

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

Efficacy
 • Time from initiation of study intervention to cessation of eSE within 60 min
 • Neurological status (including vigilance) 60 min after initiation of intervention
 • Difference of blood levels of VPA and LEV before and 60 min after initiation of intervention
 • Recurrence of seizures or noncovulsive/convulsive SE after initially successful intervention
 • For patients who failed the primary endpoint, number of patients in whom SE ceased during 60 min after initiation of intervention according to the treating physician
 • For NCSE patients who failed the primary endpoint, time to first cessation, as verified by EEG
 • Number of patients with SE- associated ventilation until hospital discharge
 • Functional outcome at discharge, defined by Barthel Index and modified Rankin Scale
Safety
 • Mortality
 • Need for any emergency medication (different from allocated study drug) during 60 min after initiation of study intervention
 • Need for ventilation (noninvasive/ invasive) during 60 min after initiation of intervention
 • Intrahospital complications
  ° Incidence of delirium as diagnoses by the treating physician
  ° Infections requiring intravenous administration of anti-infectives
  ° Adverse events related to infusion/ subsequent therapy with antiepileptic drug (sedation, dizziness, nausea, vomiting, thrombocytopenia, leukopenia, hypotension, new elevation of liver enzymes, hyperammonaemia, acute new liver or pancreatic damage, tremor, psychiatric abnormalities)
\