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

NCT05263674 | Recruiting Phase 3 DMC

• 2 other identifiers: 21/346842021-003392-34
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

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 one high-dose intra venous anti-seizure medication.

Conditions

Non-Convulsive Status Epilepticus

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with continued NCSE on EEG after 24 h ("treatment failure")

  NCSE diagnosed using EEG and defined by the "Salzburg criteria" for NCSE (e.g. Leitinger et al. Lancet Neurology, 2016)

  24 hours after randomisation

Secondary Outcomes (2)

• Number of treatment related complications

  at discharge, on average after 7 days

• New neurological deficit

  at discharge, on average after 7 days

Other Outcomes (6)

• Influence of cEEG on new neurological deficit

  at discharge, on average after 7 days

• Duration of intensive care treatment

  at discharge, on average after 7 days

• Duration of hospitalization

  1-100 days, on average 7 days

Study Arms (2)

"Non-sedative medical treatment"

NO INTERVENTION

The patient is treated with an additional high-dose intravenous antiepileptic drug, which is selected by the treating neurologist. If NCSE continues to be detected at cEEG or clinically\> 3 hours after starting treatment, the patient should receive standard treatment (i.e. sedation in the intensive care unit or addition of additional intravenous antiepileptic drugs) in accordance with local guidelines and the assessment of the treating neurologist. The following preparations are permitted as additional treatment: Levetiracetam (60 mg / kg as saturation dose followed by maintenance dose of 2-4 g / day), valproate (60 mg / kg as saturation dose followed by maintenance dose of 20 mg / kg / day), phosphenytoin (20 PE as saturation dose followed by maintenance dose 5 mg PE / kg / day), lacosamide (400 mg as a saturation dose followed by a maintenance dose of 200-400 mg / day), topiramate (200-400 mg per probe as a saturation dose followed by a maintenance dose of 200-400 mg / day).

Fast sedation

EXPERIMENTAL

Within a maximum of 60 minutes after the diagnosis of NCSE (EEG or clinical), the patient must be sedated with high-dose Propofol (bolus 3-5 g / kg, maintenance dose 5-10 mg / kg / hour) to - 5 on the Richmond agitation sedation scale (RASS) for 20 hours, and a single anti-epileptic drug should be added as adjunctive therapy. Addition of low-dose Midazolam (max. 0.1 mg / kg / h) is permitted if deep sedation (defined clinically by RASS -5) is not possible with Propofol alone. After 20 hours, the sedation should be completely phased out within 3 hours.

Drug: Rapid sedation

Interventions

Rapid sedation DRUG

High-dose Propofol (bolus 3-5 g / kg, maintenance dose 5-10 mg / kg / hour) to - 5 on the Richmond agitation sedation scale (RASS) for 20 hours, and a single anti-epileptic drug should be added as adjunctive therapy. Addition of low-dose Midazolam (max. 0.1 mg / kg / h) is permitted if deep sedation (defined clinically by RASS -5) is not possible with Propofol alone.

Fast sedation

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Aarhus University Hospital: collaborator
• University Hospital of Zealand: collaborator
• Copenhagen University Hospital, Denmark: collaborator

Study Sites (5)

Aarhus Universitetshospital

Aarhus, 8200, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Department of Neurology

Herlev, 2730, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

University Hospital of Zealand

Roskilde, 4000, Denmark

RECRUITING

Related Publications (1)

• Cornwall CD, Piilgaard H, Engedal TS, Olsen HT, Moller K, Kroigard T, Uslu B, Christensen J, Sidaros A, Beier CP. Fast Acute Sedation at Intensive Care vs. High-Dose IV Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus: A Randomized, Multicenter Trial. Crit Care Explor. 2025 Sep 15;7(9):e1311. doi: 10.1097/CCE.0000000000001311. eCollection 2025 Sep 1.

  PMID: 40953286 DERIVED

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christoph P. Beier, M.D.

CONTACT

+4565411943; cbeier@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of two treatment strategies

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: March 2, 2022
• Study Start: February 7, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)