Overview

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