Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
ConditionStatus Epilepticus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1+
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET)
- Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET)
- Levetiracetam (LEV) (60 mg/Kg)
Treatment groups
770 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Virginia
Lead sponsor
University of Michigan
Collaborator
Medical University of South Carolina
Collaborator
Massachusetts General Hospital
Collaborator
Children's National Research Institute
Collaborator
Source ClinicalTrials.gov