Actively Recruiting
Study of Anti-Seizure Treatment for Electrographic Status Epilepticus in Comatose Adults After Cardiac Arrest A Multicenter Randomized Trial with Health Economic Evaluation
Led by University of Twente · Updated on 2026-07-07
150
Participants Needed
21
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
This trial focuses on comatose adult patients after cardiac arrest who show electrographic status epilepticus ESE on continuous EEG. It aims to evaluate whether treating ESE with anti-seizure medications improves patient outcomes and to examine the impact of such treatment on healthcare costs. The study responds to the uncertainty about whether ESE treatment benefits patients or if ESE reflects irreversible brain damage, which affects treatment decisions and resource use in intensive care. Participants are randomly assigned to one of two groups the intervention group receives standard care plus a stepwise anti-seizure treatment following protocols for status epilepticus, while the control group receives standard care without anti-seizure treatment. The anti-seizure treatment involves up to three steps with medications including benzodiazepines, anti-seizure drugs like levetiracetam, valproate, or lacosamide, and continuous sedative agents such as midazolam, propofol, or ketamine. Each step is applied promptly if the previous step does not control ESE. Participants will be monitored with continuous EEG as part of standard care, and their functional recovery will be assessed using the extended Glasgow Outcome Scale eGOS six months after cardiac arrest. Additional evaluations include quality of life, cognitive function, and healthcare resource use, with cost-effectiveness analyzed separately for Belgium and the Netherlands. The study is conducted openly with blinded endpoint assessment across multiple intensive care units, with a participation period extending up to six months or longer for outcome measurements.
CONDITIONS
Brief Title
Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation-2 (TELSTAR-2)
Research Team
J
Jeannette Hofmeijer, MD
N
Nicolas Gaspard, MD
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