drugset / Trial / NCT07177235
Ketamine for the Treatment of Refractory Status Epilepticus
RandomizedParallel-groupOpen-labelTreatment
Summary
This pilot feasibility study aims to examine how the timing of ketamine introduction as a third-line anti-seizure medication infusion relates to seizure cessation in patients with refractory status epilepticus (RSE).
Timeline
- Start
- 2025-11
- Primary completion
- 2027-07
- Completion
- 2028-07
Publications
- Background Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018 Jan 18;10:153-157. doi: 10.2147/CLEP.S146397. eCollection 2018.
- Background Bruno A, Akinwuntan AE, Lin C, Close B, Davis K, Baute V, Aryal T, Brooks D, Hess DC, Switzer JA, Nichols FT. Simplified modified rankin scale questionnaire: reproducibility over the telephone and validation with quality of life. Stroke. 2011 Aug;42(8):2276-9. doi: 10.1161/STROKEAHA.111.613273. Epub 2011 Jun 16.
- Background Golub D, Yanai A, Darzi K, Papadopoulos J, Kaufman B. Potential consequences of high-dose infusion of ketamine for refractory status epilepticus: case reports and systematic literature review. Anaesth Intensive Care. 2018 Sep;46(5):516-528. doi: 10.1177/0310057X1804600514.
- Background Janssen PM, Visser NA, Dorhout Mees SM, Klijn CJ, Algra A, Rinkel GJ. Comparison of telephone and face-to-face assessment of the modified Rankin Scale. Cerebrovasc Dis. 2010 Jan;29(2):137-9. doi: 10.1159/000262309. Epub 2009 Dec 1.
- Background Legriel S, Oddo M, Brophy GM. What's new in refractory status epilepticus? Intensive Care Med. 2017 Apr;43(4):543-546. doi: 10.1007/s00134-016-4501-6. Epub 2016 Aug 20. No abstract available.
- Background Trinka E, Cock H, Hesdorffer D, Rossetti AO, Scheffer IE, Shinnar S, Shorvon S, Lowenstein DH. A definition and classification of status epilepticus--Report of the ILAE Task Force on Classification of Status Epilepticus. Epilepsia. 2015 Oct;56(10):1515-23. doi: 10.1111/epi.13121. Epub 2015 Sep 4.
- Background Fletman EW, Cleymaet S, Salvatore A, Devlin K, Pickard A, Shah SO. Ketamine plus midazolam compared to midazolam infusion for the management of refractory status epilepticus. Clin Neurol Neurosurg. 2024 Nov;246:108592. doi: 10.1016/j.clineuro.2024.108592. Epub 2024 Oct 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ketamine | Small molecule | — | Intravenous |
| Comparator | Midazolam | Small molecule | — | — |