TY - JOUR
T1 - Fast Acute Sedation at Intensive Care vs. High-Dose IV Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus
T2 - A Randomized, Multicenter Trial
AU - Cornwall, Camilla Dyremose
AU - Piilgaard, Henning
AU - Engedal, Thorbjørn Søndergaard
AU - Olsen, Hanne Tanghus
AU - Møller, Kirsten
AU - Krøigård, Thomas
AU - Uslu, Bülent
AU - Christensen, Jakob
AU - Sidaros, Annette
AU - Beier, Christoph Patrick
N1 - Copyright © 2025 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.
PY - 2025/9/1
Y1 - 2025/9/1
N2 - BACKGROUND: The 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/RESULTS: This 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.CONCLUSIONS: The 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 REGISTRATION: EU CT: 2024-515507-18-00/clinicaltrials.gov: NCT05263674.
AB - BACKGROUND: The 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/RESULTS: This 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.CONCLUSIONS: The 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 REGISTRATION: EU CT: 2024-515507-18-00/clinicaltrials.gov: NCT05263674.
KW - Humans
KW - Status Epilepticus/drug therapy
KW - Anticonvulsants/administration & dosage
KW - Prospective Studies
KW - Intensive Care Units
KW - Propofol/administration & dosage
KW - Critical Care/methods
KW - Adult
KW - Male
KW - Female
KW - Midazolam/administration & dosage
KW - Hypnotics and Sedatives/administration & dosage
KW - Randomized Controlled Trials as Topic
KW - Electroencephalography
KW - Multicenter Studies as Topic
KW - Middle Aged
KW - Deep Sedation/methods
KW - Risk
KW - Management
KW - Refractory status epilepticus
KW - Predictors
U2 - 10.1097/CCE.0000000000001311
DO - 10.1097/CCE.0000000000001311
M3 - Article
C2 - 40953286
SN - 2639-8028
VL - 7
JO - Critical Care Explorations
JF - Critical Care Explorations
IS - 9
M1 - e1311
ER -