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

RecruitingPhase 3Ages 18 Years - 120 YearsAllUniversity of Southern Denmark
NCT05263674 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Rapid sedation
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Where

5 sites
Aarhus Universitetshospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Department of Neurology
Herlev, Denmark
Odense University Hospital
Odense, Denmark
University Hospital of Zealand
Roskilde, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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