Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of… (NCT05263674) | Clinical Trial Compass
RecruitingPhase 3
Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)
Denmark140 participantsStarted 2022-02-07
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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
What they're measuring
1
Proportion of patients with continued NCSE on EEG after 24 h ("treatment failure")