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

PHASE3RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

February 7, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Non-Convulsive Status Epilepticus
Interventions
DRUG

Rapid sedation

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.

Trial Locations (4)

2100

RECRUITING

Rigshospitalet, Copenhagen

4000

RECRUITING

University Hospital of Zealand, Roskilde

5000

RECRUITING

Odense University Hospital, Odense

8200

RECRUITING

Aarhus Universitetshospital, Aarhus

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

collaborator

University Hospital of Zealand

UNKNOWN

collaborator

Copenhagen University Hospital, Denmark

OTHER

lead

University of Southern Denmark

OTHER