Established Status Epilepticus Treatment Trial (ESETT)
Benzodiazepine Refractory Status Epilepticus
About this trial
This is an interventional treatment trial for Benzodiazepine Refractory Status Epilepticus focused on measuring status epilepticus, refractory, benzodiazepine, fosphenytoin, levetiracetam, valproic acid
Eligibility Criteria
Inclusion Criteria: Patient witnessed to seize for greater than 5 minute duration prior to treatment with study drug; Patient received adequate dose of benzodiazepines. The last dose of a benzo was administered in the 5-30 minutes prior to study drug administration. The doses may be divided.; continued or recurring seizure in the Emergency Department; Age 2 years or older
Exclusion Criteria:Known pregnancy; Prisoner; Opt-out identification; Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital or other agents defined in the MoP) for this episode of SE; Treatment with sedatives with anticonvulsant properties other than benzodiazepines (propofol, etomidate, ketamine or other agents defined in the MoP); Endotracheal intubation; Acute traumatic brain injury; Known metabolic disorder; Known liver disease; Known severe renal impairment; Known allergy or other known contraindication to FOS, PHT, LEV, or VPA; Hypoglycemia < 50 mg/dL; Hyperglycemia > 400 mg/dL; Cardiac arrest and post-anoxic seizures
Sites / Locations
- Banner University Medical Center - South Campus
- Banner University Medical Center-Tucson Campus
- Ronald Reagan UCLA Medical Center
- UC Davis Children's Hospital
- San Francisco General Hospital
- UCSF Medical Center
- UCSF Benioff Children's Hospital
- Stanford University Medical Center
- Christiana Hospital
- A.I.DuPont Hospital for Children
- Children's National Medical Center
- Grady Memorial Hospital
- Children's Healthcare of Atlanta at Egleston
- University of Kentucky Hospital
- University of maryland Medical Center
- Massachusetts General Hospital
- C.S. Mott Children's Hospital
- University of Michigan Medical Center
- Children's Hospital of Michigan
- Detroit Receiving Hospital
- Henry Ford Hospital
- Sinai-Grace Hospital
- Fairview Southdale Hospital
- Hennepin County Medical Center
- University of Minnesota Medical Center
- University of Minnesota Masonic Children's Hospital
- Regions Hospital
- St. Louis Children's Hospital
- Hackensack University Medical Center
- Kings County Hospital Center
- SUNY Downstate Medical Center
- Maimonides Medical Center
- NYP Columbia University Medical Center
- NYP Morgan Stanley Children's Hospital
- University of Cincinnati Medical Center
- Cincinnati Children's Hospital Medical Center
- Nationwide Children's Hospital
- OSU Wexner Medical Center
- Oregon Health & Science University Hospital
- Crozer-Chester Medical Center
- Penn State Hershey Medical Center
- Hahnemann University Hospital
- Children's Hospital of Philadelphia
- Hospital of the University of Pennsylvania
- Penn Presbyterian Medical Center
- Pennsylvania Hospital
- Temple University Hospital Episcopal Campus
- Temple University Hospital
- Einstein Medical Center
- Allegheny General Hospital
- UPMC Presbyterian Hospital
- UPMC Mercy Hospital
- Children's Hospital of Pittsburgh UPMC
- Hasbro Children's Hospital
- Rhode Island Hospital
- Children's Medical Center UTSW
- Lyndon B. Johnson General Hospital
- Memorial Hermann Texas medical Center
- Texas Children's Hospital
- University Health System University Hospital
- Primary Children's Hospital
- University of Virginia
- VCU Medical Center
- Children's Hospital of Wisconsin
- Froedtert Memorial Lutheran Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Fosphenytoin (FOS)
Valproic acid
Levetiracetam
Administer 20 mg/Kg fosphenytoin intravenously up to a maximum dose of 1500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 1500 fosphenytoin over 10 minutes.
Administer 40 mg/Kg valproic acid intravenously up to a maximum dose of 3000 mg (75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 3000 valproic acidover 10 minutes.
Administer 60 mg/Kg levetiracetam intravenously up to a maximum dose of 4500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 4500 levetiracetam over 10 minutes.