The ESETT Study

Principal Investigator

Name

Emergency Department ResearchA research study is a way for doctors to find new information about a disease, or best way to treat a condition• Research helps doctors develop the best

treatment for patients in all areas of medicine, including emergency medicine

• Conducting research in an emergency department can be difficult because the patient can be very sick

What is a seizure?Seizures are a common childhood illness. A seizure causes jerking activity of the body and can cause unconsciousness• Epilepsy (i.e. seizure disorder) is the most

common cause of a seizures• Other causes include:• Brain injury or tumor• Stroke• Alcohol intoxication or drug use• High fever (in children)

What is Status Epilepticus?

• Status Epilepticus is seizure activity that does not stop

• It can cause unconsciousness and jerking activity of the body

• It is a medical emergency!

• Patients with status epilepticus are given medicine, like valium, to make their seizures stop.

What are the dangers of status epilepticus?o Possible brain damageo Low oxygeno Direct nerve injuryo Other tissue damage—muscle and kidneyo DeathThe longer a seizure continues the greater the chance the patient could die from their seizure.

What is Established Status Epilepticus (ESE)?

Seizures that continue after treatment with medicines like valium are known as Established Status Epilepticus, ESE.

o ESE may be treated with many different medicineso Sometimes two or more drugs may be needed to stop

the seizure.

We do not know which drug is best at stopping ESE.

Doctors at XXX are joining 39 other hospitals across the country to conduct

a study to find out the best way to treat Established Status Epilepticus

(ESE)

The ESETT Study

ESETT is a research study designed to find out

which of three commonly used drugs is best to

stop established status epilepticus.

The medicines being studied are:

• Fosphenytoin (Cerebyx)

• Valproic acid (Depakote)

• Levetiracetam (Keppra)

ESETT

Who will be included in this study?

• Any patient who is 2 years or older with an

• active recurrent or ongoing seizure activity lasting longer than 5 minutes AND

• Has already received an adequate dose of benzodiazepine (like valium) in the past 5-30 minutes to make the seizure stop.

Who cannot be in this study?

• Any person less than 2 years of age• Patients with low or high blood sugar• Women known to be pregnant• Prisoners or anyone known to be in police custody• Patients who have said they do not want to be in

the study by a medic alert tag or opt-out bracelet

How will the study work?

• Every patient coming to the ED who is eligible will be considered for the study.

• Everyone in this study will be treated with a medication for their seizure.

• Patients who are enrolled in the study will receive a single dose of one of the three drugs being studied through a needle in the vein (IV).

How will the study drug be chosen?

• To start 1/3 of patients will randomly get fosphenytoin, 1/3 levetiracetam and 1/3 valproic acid.

• As the study goes on, a higher proportion of patients will be randomized to the drug or drugs doing better.

What else will happen in the study?

• A teaspoon of blood may be taken to test for the study medicine in the blood.

• If the seizure does not stop doctors will follow their normal procedures to try to make it stop.

• More medicine may be given—this may be one of the study medicines or a different medicine.

• The study team will monitor the patient while he or she is in the hospital.

What are the possible risks of ESETT?

• There are risks involved in participating in research. Risks and possible side effects of any of the study medicines include: drowsiness, dizziness, and an allergic reaction.

• Additionally:• Fosphenytoin may cause low blood pressure, slow heart rate,

inflammation of the blood vessels, or skin rash. • Levetiracetam may cause behavior changes such as nervousness,

confusion, or aggression.• Valproic acid may also cause a skin rash and liver or pancreas

problems.

• There may be other risks that we are unaware of.

All three drugs are commonly used by

doctors to treat seizures

The risks of the study medicines are the same whether they are given in the study or for treatment of seizures outside of this study.

What are the possible benefits of ESETT?

• Because we do not know which of the study drugs is better, study participants may benefit from receiving a better medicine.

• The information we collect may help us to provide more effective drugs in the future for patients with seizures.

How is this study different from most other studies?

In other studies,• A study investigator explains the study and its risks and

benefits.• The person is able ask questions about the study.• The person decides to be in the study or not.This process is called INFORMED CONSENT.

In this study,• Patients with seizures are unconscious and therefore

cannot give permission to participate in the study.• Also, the study medicine has to be given quickly to stop

the seizure activity. Therefore, there is not time to explain the study to family and ask for their consent in advance.

Rules for EmergencyResearchWith Emergency Research like ESETT, it’s not possible to get informed consent before treating the patient. The federal government allow for this kind of research following procedures called: Exception From Informed Consent or “EFIC”EFIC allow research to begin without informed consent.

The researchers who perform research in emergency settings are carefully supervised:• Locally by Institutional Review Boards, also called IRBs, which

work to protect the safety of patients participating in research.• And federally there is oversight by the National Institutes of

Health, the Food and Drug Administration, and the Office of Human Research Protections.

EFIC can only be used 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:

o from the person because of his or her medical condition, oro from the person’s family because the medical condition needs to be

treated very quickly.

The Emergency Research Procedures for ESETT:

• All patients having seizures in the ED will immediately be given the usual treatment for seizures– a drug like valium.

• If the first drug does not stop the seizure, ESETT patients will be treated next with one of the study medications.

• Patients having seizures will not be able to give consento They are not awakeo They need emergency treatment and there is not time to consent a

legal guardian or parent.

What happens next?• If the seizure does not stop doctors will follow

their normal procedure and give more medication to make the seizure stop.

• Once the patient wakes up or the LAR is found, he or she will be asked for permission to continue in the study.

• If the patient continues in the study, he or she will be monitored by the study team until leaving the hospital.

What if a person does not want to be in the study?

Procedures are in place to identify those who do not want to participate. As a part of these procedures, a person may be asked to:• Wear medical jewelry, like a bracelet, with the

message “ESETT declined” at all times during the study .

What do you think about ESETT?

The study has not started yet, so . . .• We want to hear what you think about it.• Do you think it is okay to do this study?

The study team and the local research review board will consider your opinions before deciding if it is okay to do the study in our community.

Click here (on the link below) to complete the survey.

<<insert link to survey>>

Where is ESETT Planning to take

place?NETT Hubs PECARN Sites

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