Established Status Epilepticus Treatment Trial
Established Status Epilepticus Treatment Trial- Public Disclosure
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.
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, so the person will be enrolled in the study without his/her legal representative’s consent. This is called “Exception from Informed Consent” (EFIC). Once the representative is located or the patient wakes up, they will be asked to give their permission to continue in the study.
The purpose of this handout is to notify our community about this trial, to provide contact
information and resources where you can learn more, including an option to decline participation.