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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    140
  • sponsor
    University of Southern Denmark
Updated on 7 October 2022

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.

Description

Persistent epileptic seizures, aka. status epilepticus (SE), are the second most common neurological cause of acute admissions. Around halv of the patients suffers from SE without prominent visible seizures ("convulsions"), which is referred to as non-convulsive status epilepticus (NCSE) and is afflicted with a long-term mortality of >50% also in patients without concomittant acute brain disease. There are no evidence-based treatment guidelines for NCSE but patients usually receive treatment with benzodiazepines followed by i.v. anti-seizure medication. If seizures continues, further treatment is controversial. The participating centers have long-standing experience in treating NCSE but use different, internationally accepted treatment strategies. Some initiate aggressive treatment with fast sedation at intensive care aiming at immediate seizure control, other estimate that the side effects of sediation does not outweigh the potential benefit and try high-dose i.v. anti-seizure medication that only slightly impair conciousness - often with success.

This randomized, open label, multicenter trial (Eudract 2021-003392-34) aims at clarifying the treatment of patients with NSCE not responding to standard therapy. Patients with verified NCSE based on clinical parameter or using electroencephalography (EEG) are randomized into a fast acute sedation group and a group that receives at least one additional, high-dose anti-seizure mediciation.

Primary objective endpoint is treatment failure 24 h after randomization as determined by EEG. Secondary endpoints are e.g. seizure-induced neurological damage, treatment-related complications and neurological long-term outcome.

The statistical planing aims at showing superiority of aggressive treatment, 140 patients shall be included in a three years period at the University Hospitals in Aarhus, Odense, Roskilde and Copenhagen.

Details
Condition Non-Convulsive Status Epilepticus
Treatment Rapid sedation
Clinical Study IdentifierNCT05263674
SponsorUniversity of Southern Denmark
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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