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Efficacy
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• Time from initiation of study intervention to cessation of eSE within 60 min
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• Neurological status (including vigilance) 60 min after initiation of intervention
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• Difference of blood levels of VPA and LEV before and 60 min after initiation of intervention
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• Recurrence of seizures or noncovulsive/convulsive SE after initially successful intervention
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• 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
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• For NCSE patients who failed the primary endpoint, time to first cessation, as verified by EEG
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• Number of patients with SE- associated ventilation until hospital discharge
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• Functional outcome at discharge, defined by Barthel Index and modified Rankin Scale
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Safety
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• Mortality
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• Need for any emergency medication (different from allocated study drug) during 60 min after initiation of study intervention
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• Need for ventilation (noninvasive/ invasive) during 60 min after initiation of intervention
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• Intrahospital complications
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° Incidence of delirium as diagnoses by the treating physician
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° Infections requiring intravenous administration of anti-infectives
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° 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)
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