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Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)

RecruitingPhase 3

Who can join

Ages 1 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* The patient was witnessed to have a convulsive seizure for greater than 5-minute duration
* The patient received an adequate dose of benzodiazepines. The doses may be divided.
* The last dose of a benzodiazepine was administered 5-30 minutes before study drug administration.
* Continued or recurring seizures in the Emergency Department.
* Age 1 years or older
* Known or estimated weight ≥10 Kg

Exclusion Criteria:

* Known pregnancy
* Prisoner
* Opt-out identification or otherwise known to be previously enrolled in KESETT
* 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 for this episode of SE(propofol, etomidate, ketamine or other agents defined in the MoP)
* Endotracheal intubation prior to enrollment
* Acute traumatic brain injury clearly precedes seizures
* Scalp injury or burn preventing EEG placement
* Known allergy or other known contraindication to KET or LEV
* Hypoglycemia \< 50 mg/dL
* Hyperglycemia \> 400 mg/dL
* Cardiac arrest / post-anoxic seizures

About the study

The goal of this clinical trial is to determine if treatment of patients with two doses of ketamine plus levetiracetam versus levetiracetam alone leads to more effective control of status epilepticus.

What is being tested

Sponsor: University of Virginia · Participants: 770 · Started: Mar 6, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT06907173

Locations in the U.S.

AlabamaUAB Hospital, Birmingham (Not yet recruiting)
ArizonaBanner University Medical Center - Tucson Campus, Tucson
CaliforniaUC San Diego Health La Jolla, La Jolla (Not yet recruiting)
Children's Hospital Los Angeles, Los Angeles (Not yet recruiting)
Ronald Reagan UCLA Medical Center, Los Angeles (Not yet recruiting)
Stanford University Medical Center, Palo Alto
UC Davis Medical Center, Sacramento
Rady Children's Hospital, San Diego (Not yet recruiting)
UC San Diego Health Hillcrest Hospital, San Diego (Not yet recruiting)
San Francisco General Hospital, San Francisco
UCSF Medical Center, San Francisco
Harbor-UCLA Medical Center, Torrance (Not yet recruiting)
ConnecticutYale New Haven Hospital, New Haven
DelawareChristiana Hospital, Newark (Not yet recruiting)
Nemours Children's Hospital, Wilmington
District of ColumbiaChildren's National Medical Center, Washington D.C.
FloridaOrlando Regional Medical Center, Orlando
GeorgiaArthur M. Blank Hospital, Atlanta
IllinoisComer Children's Hospital, Chicago
Northwestern Memorial Hospital, Chicago (Not yet recruiting)
Rush University Medical Center, Chicago
University of Chicago Medical Center, Chicago
University of Illinois Hospital, Chicago (Not yet recruiting)
IndianaIU Health Methodist Hospital, Indianapolis
Riley Hospital for Children, Indianapolis
IowaUniversity of Iowa Medical Center, Iowa City
LouisianaUniversity Medical Center New Orleans, New Orleans (Not yet recruiting)
MarylandJohns Hopkins Hospital, Baltimore
University of Maryland Medical Center, Baltimore
MassachusettsMassachusetts General Hospital, Boston (Not yet recruiting)
MichiganUniversity of Michigan University Hospital, Ann Arbor
Detroit Receiving Hospital, Detroit (Not yet recruiting)
Henry Ford Hospital, Detroit (Not yet recruiting)
Sinai-Grace Hospital, Detroit (Not yet recruiting)
MinnesotaHennepin County Medical Center, Minneapolis (Not yet recruiting)
University of Minnesota Masonic Children's Hospital, Minneapolis
University of Minnesota Medical Center, Minneapolis
New JerseyCooper University Hospital, Camden (Not yet recruiting)
New MexicoUniversity of New Mexico Hospital, Albuquerque (Not yet recruiting)
New YorkSUNY Upstate Medical University, Syracuse (Not yet recruiting)
North CarolinaDuke University Hospital, Durham (Not yet recruiting)
OhioUniversity of Cincinnati Medical Center, Cincinnati
Nationwide Children's Hospital, Columbus
OSU Wexner Medical Center, Columbus
OregonOregon Health & Science University Hospital, Portland
PennsylvaniaHospital of the University of Pennsylvania, Philadelphia (Not yet recruiting)
Jefferson Einstein Philadelphia Hospital, Philadelphia
Penn Presbyterian Medical Center, Philadelphia (Not yet recruiting)
Temple University Hospital Jeanes Campus, Philadelphia
Temple University Hospital Main Campus, Philadelphia
UPMC Children's Hospital of Pittsburgh, Pittsburgh
UPMC Presbyterian Hospital, Pittsburgh
Reading Hospital, West Reading
TexasChildren's Medical Center Dallas, Dallas (Not yet recruiting)
Memorial Hermann Texas Medical Center, Houston
UtahPrimary Children's Hospital, Salt Lake City (Not yet recruiting)
University of Utah Healthcare, Salt Lake City (Not yet recruiting)
VirginiaUniversity of Virginia Medical Center, Charlottesville
VCU Medical Center, Richmond (Not yet recruiting)
WashingtonHarborview Medical Center, Seattle
WisconsinChildren's Hospital of Wisconsin, Milwaukee
Froedtert Hospital, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.