Lessons from the Established Status Epilepticus Treatment Trial.
Adult
Anticonvulsants
/ therapeutic use
Benzodiazepines
/ therapeutic use
Child, Preschool
Clinical Trials as Topic
/ methods
Diagnostic Tests, Routine
/ methods
Double-Blind Method
Emergency Service, Hospital
/ standards
Female
Humans
Levetiracetam
/ therapeutic use
Male
Status Epilepticus
/ diagnosis
Treatment Outcome
Valproic Acid
/ therapeutic use
Clinical trial
Levetiracetam
Methodology
Phenytoin
Status epilepticus
Valproate
Journal
Epilepsy & behavior : E&B
ISSN: 1525-5069
Titre abrégé: Epilepsy Behav
Pays: United States
ID NLM: 100892858
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
30
03
2019
accepted:
27
04
2019
pubmed:
28
10
2019
medline:
28
7
2020
entrez:
27
10
2019
Statut:
ppublish
Résumé
Convulsive status epilepticus (SE) is a relatively common emergency condition affecting individuals of all ages. The primary goal of treatment is prompt termination of seizures. Where first-line treatment with benzodiazepine has failed to achieve this, a condition known as established SE (ESE), there is uncertainty about which agent to use next. The Established Status Epilepticus Treatment Trial (ESETT) is a 3-arm (valproate (VPA), fosphenytoin (FOS), levetiracetam (LEV)), phase III, double-blind randomized comparative effectiveness study in patients aged 2 years and above with established convulsive SE. Enrollment was completed in January 2019, and the results are expected later this year. We discuss lessons learnt during the conduct of the study in relation to the following: ethical considerations; trial design and practical implementation in emergency settings, including pediatric and adult populations; quality assurance; and outcome determination where treating emergency clinicians may lack specialist expertise. We consider that the ESETT is already informing both clinical practice and future trial design. This article is part of the Special Issue "Proceedings of the 7th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures".
Identifiants
pubmed: 31653603
pii: S1525-5050(19)30303-8
doi: 10.1016/j.yebeh.2019.04.049
pmc: PMC6944752
mid: NIHMS1544406
pii:
doi:
Substances chimiques
Anticonvulsants
0
Benzodiazepines
12794-10-4
Levetiracetam
44YRR34555
Valproic Acid
614OI1Z5WI
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
106296Subventions
Organisme : NINDS NIH HHS
ID : U01 NS073476
Pays : United States
Organisme : NINDS NIH HHS
ID : U01 NS059041
Pays : United States
Organisme : NINDS NIH HHS
ID : U01 NS056975
Pays : United States
Organisme : NINDS NIH HHS
ID : R01 NS099653
Pays : United States
Organisme : NINDS NIH HHS
ID : U01 NS088034
Pays : United States
Organisme : NINDS NIH HHS
ID : U01 NS088023
Pays : United States
Informations de copyright
Copyright © 2019 Elsevier Inc. All rights reserved.
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