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Nationwide Children's Hospital is one of forty sites in the United States participating in this multi-center research study designed to find out which of three commonly used, FDA-approved drugs best stops established status epilepticus.
What is Status Epilepticus (SE)?
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 or regaining consciousness (waking up).
- There are approximately 120,000-180,000 episodes of SE each year in the United States.
- About one third of SE patients continue to have a seizure despite receiving adequate doses of medicine (benzodiazepines) to make it stop.
- SE affects individuals of all ages, from the very young to the elderly.
What is ESETT?
ESETT is a multi-center emergency medicine study designed to try to save and improve the lives of people who experience a seizure that will not stop on its own or has not responded to a medicine like valium. Emergency Department care of these patients is not the same across the U.S. Because it is not known which drug best treats this type of seizure, different doctors use different medicines.
For this reason, this study (ESETT) plans to look at three commonly used medicines given in the emergency departments for a seizure not stopping: fosphenytoin (fPHT), valproic acid (VPA), and levetiracetam (LVT) to learn which treatment is best at stopping a seizure quickly. All three of these medications are FDA-approved for seizures, which means all patients in the study will be receiving treatment.
How is ESETT different from other studies?
Normally, researchers get permission before a person can be included in a study. A person having a seizure will NOT be able to give consent. 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.
Because of this, all patients 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 participant wakes up, they will be told about the study and asked to give their permission to continue in the study. For more information on Exception from Informed Consent, please read the last section on this page, entitled What is Exception from Informed Consent (EFIC)?
Why is ESETT important?
The best possible outcomes for seizing patients are likely to depend on a treatment that leads to a rapid stop of the seizure. The reason for doing this study is to find out which of three commonly used drugs is safer and faster at stopping seizures.
Who will be included in the study?
- Any patient who is two (2) years old or older with an
- Active recurrent or ongoing seizure lasting longer than five minutes, AND
- Has already received an adequate dose of benzodiazepine (like valium) in the past 5-30 minutes for a generalized tonic-clonic seizure could be enrolled.
How will someone be entered into the study?
Every patient coming to the ED who is eligible for the study (if they meet ALL three of the inclusion criteria listed above) will get study treatment.
If you do not wish to be enrolled into the ESETT study, you can wear an "ESETT Declined" bracelet at all times during the study enrollment period (approximately five years, beginning August 2015). If you are wearing this bracelet when you arrive at any participating hospital, researchers will know not to enroll you in this study. If you would like to wear a bracelet to opt out of the ESETT study, please contact the study team or complete this form and submit it by mail.
What are the benefits of this study?
Because we do not know which of the FDA-approved drugs in this study is better, participants may benefit from receiving a better medicine, although this is not guaranteed. Some participants may not get any benefit from being in this research study, but all will be receiving an FDA-approved treatment for their seizures. Additionally, the information obtained from this study may help seizure patients in the future.
What is Exception from Informed Consent (EFIC)?
The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research involving medicine. The FDA has allowed a set of special rules, called “Exception from Informed Consent” (EFIC), to guide emergency research. EFIC allows research studies to be done in certain emergency situations.
EFIC only applies when:
- The person's life is at risk, AND
- The best treatment is not known, AND
- The study might help the person, AND
- It is not possible to get permission:
- from the person, because of his or her medical problem, OR
- from the person's legally authorized representative because the medical problem must be treated very quickly
Before researchers may do a study using EFIC, they must provide information about the study to the community and get their feedback. This is known as public disclosure and community consultation. The ESETT team at Nationwide Children's Hospital has notified the community about this trial and surveyed the public to ensure clarity and transparency.
Contact Information for the ESETT Study Team at Nationwide Children's
Daniel M. Cohen, M.D.
For more general information on ESETT, including Fast Facts and a toolbox with additional resources, please visit the www.nett.umich.edu/clinical-trials/esett.