Evidence map›Paper›PMID 40953286›Full record

ArticleCritical care explorations2025

Fast Acute Sedation at Intensive Care vs. High-Dose IV Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus: A Randomized, Multicenter Trial.

Camilla Dyremose Cornwall, Henning Piilgaard, Thorbjørn Søndergaard Engedal, Hanne Tanghus Olsen, Kirsten Møller, Thomas Krøigård, Bülent Uslu, Jakob Christensen, Annette Sidaros, Christoph Patrick Beier

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Critical care explorations, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05263674 (Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05263674 phase3recruitingnot on this map

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

TypeinterventionalSponsorUniversity of Southern DenmarkRan2022 to 2028Enrolled140ConditionsNon-Convulsive Status EpilepticusArmsRapid sedation
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Camilla Dyremose CornwallDepartment of Neurology, Odense University Hospital, Odense, Denmark.
Henning PiilgaardDepartment of Neurology, Zealand University Hospital, Roskilde, Denmark.
Thorbjørn Søndergaard EngedalDepartment of Clinical Neurophysiology, Aarhus University Hospital, Aarhus, Denmark.
Hanne Tanghus OlsenDepartment of Anesthesiology, Odense University Hospital, Odense, Denmark.
Kirsten MøllerDepartment of Neuroanaesthesiology, Neuroscience Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Thomas KrøigårdDepartment of Neurology, Odense University Hospital, Odense, Denmark.
Bülent UsluDepartment of Anesthesia and Intensive Care Medicine, Zealand University Hospital, Roskilde, Denmark.
Jakob ChristensenDepartment of Neurology, Aarhus University Hospital, affiliated member of EpiCARE, Aarhus, Denmark.
Annette SidarosDepartment of Clinical Neurophysiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Christoph Patrick BeierDepartment of Neurology, Odense University Hospital, Odense, Denmark.ORCID 0000-0001-8268-1492

Funding

Danish Regions
6 · The paper itself

Abstract

backgroundThe management of refractory status epilepticus (SE) remains an area of low evidence with varying management strategies. Treatment in the ICU is often postponed due to potential complications from sedation, and it is unknown if its efficacy is superior to additional treatment attempts with IV anti-seizure medications (ASMs). The Fast Acute Sedation at Intensive Care vs. High-Dose IV Anti-Seizure Medication for Treatment of Non-Convulsive Status Epilepticus (FAST) trial aims to compare the efficacy of rapid sedation in the ICU vs. add-on high-dose IV ASM alone for the treatment of refractory SE. METHODS/

resultsThis prospective, randomized, multicenter trial will enroll adult patients with non-convulsive status epilepticus (NCSE) who either meet current EEG criteria or have unambiguous NCSE with minor motor phenomena ("subtle SE") but without ongoing tonic-clonic seizures that are refractory to benzodiazepines and treatment with at least one second-line ASM. Patients will be randomized to receive either rapid deep sedation for 20 hours with propofol and eventually low-dose midazolam or additional high-dose IV anticonvulsant therapy (levetiracetam, valproate, fosphenytoin, lacosamide, or topiramate) in the intermediate care unit. The primary endpoint is treatment failure, either defined as NCSE on EEG 24 hours after randomization or persistent NCSE after 3 hours despite therapy on continuous EEG or clinically. Secondary endpoints include assessment of new-onset neurologic deficits and modified Rankin Scale at discharge, economic analyses, length of hospital stay, in-hospital infections, and survival. Evaluations will be performed at baseline, discharge, and 3, 6, 12, and 24 months. The target sample size is 116 patients; we expect to have to randomize about 140 patients to reach the required number of patients.

conclusionsThe FAST trial is the first randomized clinical trial to investigate refractory NCSE. Regardless of the outcome, the results of this trial protocol will provide new class 1 evidence for the treatment of NCSE and establish the standard of care for this patient population in the future.

trial registrationEU CT: 2024-515507-18-00/clinicaltrials.gov: NCT05263674.

Indexed as

AnticonvulsantsCritical CareDeep SedationHypnotics and SedativesStatus EpilepticusAdultElectroencephalographyFemaleHumansIntensive Care UnitsMaleMidazolamMiddle AgedMulticenter Studies as TopicPropofolProspective StudiesAnticonvulsantsHypnotics and SedativesMidazolamPropofol

Identifiers

PMID40953286
PMCPMC12440533

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.