This open-label, randomized multicenter trial aims at clarifying the standard of care of patients with non-convulsive status epilepticus not responding to treatment with benzodiazepines and at least one high-dose intra venous anti-seizure medication.
Adult patients (older than 18 years) with EEG-verified NCSE, according to the Salzburg criteria, who have not responded to appropriate treatment with benzodiazepines and at least one 2nd line i.v. anti-seizure medication according to the current Danish national neurological treatment guidelines (Levetiracetam, Fosfenytoin or Valproate).
patients with epilepticus status due to acute neuroinfection (e.g. bacterial meningitis or viral encephalitis)
acute traumatic or spontaneous intracranial hemorrhage
suspicion of cerebral anoxia / hypoxia / hypoglycemia / epileptic encephalopathy
contraindications to anti-seizure medication defined in the protocol
Parallel
Rapid sedation
DrugHigh-dose Propofol (bolus 3-5 g / kg, maintenance dose 5-10 mg / kg / hour) to - 5 on the Richmond agitation sedation scale (RASS) for 20 hours, and a single anti-epileptic drug should be added as adjunctive therapy. Addition of low-dose Midazolam (max. 0.1 mg / kg / h) is permitted if deep sedation (defined clinically by RASS -5) is not possible with Propofol alone.
Proportion of patients with continued NCSE on EEG after 24 h ("treatment failure")
NCSE diagnosed using EEG and defined by the "Salzburg criteria" for NCSE (e.g. Leitinger et al. Lancet Neurology, 2016)
Number of treatment related complications
e.g. tracheostoma, infections
New neurological deficit
Neurological deficits are quantified using National Institute of Health Stroke Scale (NIHSS, maximum possible score is 42, the minimum score - indicating no deficits - is 0) at admission and discharge. New neurological deficit is defined as increase of NIHSS \>5 at discharge
Influence of cEEG on new neurological deficit
Patients receive either cEEG or spot EEG depending on the center. In this pre-specified analyses, the impact of cEEG vs. spot-EEG on the degree of new neurological deficits (outcome 3) will be compared
Duration of intensive care treatment
Definition: Time from intubation to discharge from ICU
Duration of hospitalization
Time from randomization to discharge from hospital in charge for acute treatment of NCSE
Proportion of patients with superrefractory status epilepticus
Proportion of patients that develop superrefractory status epilepticus after randomization but during current hospitalization
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University of Southern Denmark
Lead sponsor
Aarhus University Hospital
Collaborator
University Hospital of Zealand
Collaborator
Copenhagen University Hospital, Denmark
Collaborator
