Established Status Epilepticus Treatment Trial (ESETT)

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 difioresm@upmc.edu.

More information at www.esett.org