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RECRUITING
NCT05263674
PHASE3

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

Sponsor: University of Southern Denmark

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2022-02-07

Completion Date

2028-12-31

Last Updated

2024-12-11

Healthy Volunteers

No

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.

Locations (4)

Aarhus Universitetshospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

University Hospital of Zealand

Roskilde, Denmark