The University of Arizona Department of Emergency Medicine is seeking community input on a clinical trial that requires giving a drug for seizures without patient consent.
The Established Status Epilepticus Treatment Trial (ESETT) will determine which of three drugs, fosphenytoin, valproic acid or levetiracetam, is safer and more effective at stopping prolonged seizures. The trial, which is set to begin this spring at Banner – University Medical Center South and Banner – University Medical Center Tucson, will be performed on seizing patients who are unable to provide informed consent.
An Institutional Review Board responsible for human subject research at the University of Arizona reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and university policies designed to protect the rights and welfare of participants in research.
A seizure lasting longer than five minutes that does not stop after receiving a full dose of medicine to make it stop is commonly referred to as established status epilepticus (ESE) and can happen to anyone. ESE can affect someone’s ability to think and remember, and can lead to coma, permanent brain damage or death. Care of a patient in the hospital with ESE is not standardized. Doctors use their best judgment, but do not know which treatment is most effective at stopping prolonged seizures. The purpose of this study is to determine which of the commonly used medicines given in the emergency department is safest and most effective.
Patients who are 2 years of age or older, have a seizure lasting longer than five minutes and who have received medicines to stop the seizure that have not worked will be included in this study. All study participants will receive one of the following study drugs: fosphenytoin, valproic acid or levetiracetam. Blood samples may be taken to measure the level of the study drug. As the study continues, if one of the study drugs is shown to be more effective than the others, more patients will receive the study drugsshown to be more effective at stopping seizures.
These study drugs are already used to treat ESE, but physicians are not sure which treatment is best. The risks of the study drugs are similar to those that a patient might have if they receive treatment for their seizures outside of this study. Based on the study’s results, future patients who have prolonged seizures may benefit from this study.
Because seizing patients are unconscious and unable to give consent to participate in the study, this trial falls under a unique Food and Drug Administration (FDA) regulation concerning “exception from informed consent (EFIC).” Such regulations are strict and the research must meet very specific federal regulations and local Institutional Review Board (IRB) review and approval. This gives physicians in the emergency room the ability to enroll patients into the study even though they cannot speak for themselves to give or deny consent because of life-threatening injury or illness.
If you would like more information about the trial, you can visit www.esett.org.
One requirement of this regulation is that the community is educated about the study. The Arizona Emergency Medicine Research Center in the UA Department of Emergency Medicine is in the process of providing information to the community and asking for feedback. You can provide feedback to the researchers or request an opt-out bracelet that indicates to medical staff that you do not want to be part of the study.
If you would like to participate in a survey, provide feedback, ask questions or request a bracelet to wear showing that you do not want to be included in the study, please contact the primary nurse coordinator for the trial, Cyndra Scheu, 520-626-8534.