Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-120
SponsorUniversity of Southern Denmark

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Rapid sedation

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Southern Denmark

Lead sponsor

Aarhus University Hospital

Collaborator

University Hospital of Zealand

Collaborator

Copenhagen University Hospital, Denmark

Collaborator