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

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern Denmark
• Collaborators: Aarhus University Hospital; Copenhagen University Hospital, Denmark; University Hospital of Zealand

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

• contraindications to anesthesia treatment in intensive care

• focal motor status epilepticus without relevant conscious influence (Glasgow Coma Scale> 13)

• known epileptic encephalopathy

• Clinical need for acute intubation