Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
University of Virginia
770 participants
Mar 6, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria6
- 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 Criteria12
- 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
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Interventions
The study drug will be produced at the central pharmacy, a GMP facility at the University of California, Davis. Diluted formulations are expected to remain stable for months when stored at room temperature. Expiration dates for study drugs will be determined and adjusted based on ongoing stability testing performed on study drugs prepared at the GMP facility for the study. All three formulations will be transparent solutions. None of the formulations are reported to consistently cause adverse effects at the infusion site. The method of drug administration, including volume and rate of infusion, is identical for all three drugs. These factors ensure that drug administration will be blinded.
The study drug will be produced at the central pharmacy, a GMP facility at the University of California, Davis. Diluted formulations are expected to remain stable for months when stored at room temperature. Expiration dates for study drugs will be determined and adjusted based on ongoing stability testing performed on study drugs prepared at the GMP facility for the study. All three formulations will be transparent solutions. None of the formulations are reported to consistently cause adverse effects at the infusion site. The method of drug administration, including volume and rate of infusion, is identical for all three drugs. These factors ensure that drug administration will be blinded.
The study drug will be produced at the central pharmacy, a GMP facility at the University of California, Davis. Diluted formulations are expected to remain stable for months when stored at room temperature. Expiration dates for study drugs will be determined and adjusted based on ongoing stability testing performed on study drugs prepared at the GMP facility for the study. All three formulations will be transparent solutions. None of the formulations are reported to consistently cause adverse effects at the infusion site. The method of drug administration, including volume and rate of infusion, is identical for all three drugs. These factors ensure that drug administration will be blinded.
Locations(51)
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NCT06907173