Status:
RECRUITING
Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)
Lead Sponsor:
University of Southern Denmark
Collaborating Sponsors:
Aarhus University Hospital
University Hospital of Zealand
Conditions:
Non-Convulsive Status Epilepticus
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief 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 o...
Detailed 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 se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05263674
Start Date
February 7 2022
End Date
December 31 2028
Last Update
December 11 2024
Active Locations (4)
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1
Aarhus Universitetshospital
Aarhus, Denmark, 8200
2
Rigshospitalet
Copenhagen, Denmark, 2100
3
Odense University Hospital
Odense, Denmark, 5000
4
University Hospital of Zealand
Roskilde, Denmark, 4000