Status Epilepticus (SE) is a life-‐threatening condition in which the brain is in a state of persistent seizure. SE is defined as a seizure or recurrent seizures lasting longer than five minutes without stopping on its own or without waking up. A person whose seizure does not stop even after receiving a full dose of medicine (benzodiazepines) to make it stop is considered to have Established Status Epilepticus (ESE).
There are approximately 120,000 – 180,000 episodes of SE each year in the US. About one third of SE patients continue to have a seizure that will not stop or ESE. Long-‐lasting seizures can affect a person’s ability to think and remember things. It can prevent a person from returning to work or functioning independently. Seizures can cause permanent brain damage or even death.
ESETT is an emergency medicine research study designed to try to save and improve the lives of people who experience a seizure lasting longer than five minutes and, which has failed to respond to a full dose of a benzodiazepine (like valium). Emergency department care of Established Status Epilepticus (ESE) in the US is not the same everywhere. Doctors use their judgment, but what treatment will work best is not known.
This study plans to look at three commonly used medicines given in the emergency departments to treat ESE: fosphenytoin (fPHT), valproic acid (VPA), and levetiracetam (LVT) to learn which treatment is most effective at stopping a seizure quickly. When a patient with ESE arrives in a participating emergency department, doctors will administer one of these three medicines, but will choose the medicine based on a random (like flipping a coin) number generated by a computer. All patients will be treated with one of these medicines, unless they are known to be allergic to one or more.
Normally, researchers get permission (consent) before a person can be included in a study. A person having a seizure that will not stop will not be able to give consent at the time they could be enrolled. Since a seizure that will not stop on its own must be treated quickly, there will not be enough time to locate and talk to the person’s legal representative about the study. Therefore, this study will be conducted under an Exception from the Requirement for Informed Consent for Emergency Research which includes community consultation and public notification.
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Participants or their representatives will be notified that they participated in this research as soon as possible after the emergency.
If you wish to comment on this study, please contact us. Community members who do not wish to participate in this research study should contact Emergency Medicine at 412.647-3078 or email at email@example.com.
More information at www.esett.org