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

Launched by UNIVERSITY OF VIRGINIA · Mar 31, 2025

Keywords

ClinConnect Summary

The KESETT trial is a study that aims to find out whether adding two doses of a medication called ketamine to standard treatment (levetiracetam) can help control a serious condition called status epilepticus, which is a prolonged seizure lasting more than five minutes. This trial will involve patients who are 1 year or older and weigh at least 10 kilograms. To be eligible, participants must have experienced a convulsive seizure that lasted longer than five minutes, received adequate treatment with benzodiazepines (a type of medication used for seizures), and still be having seizures when they arrive at the Emergency Department.

If you or a loved one participates in this study, you can expect to receive either the ketamine plus levetiracetam treatment or just the levetiracetam alone. The trial is not yet recruiting, so more information will be available soon. It’s important to note that there are specific criteria that would exclude some patients, such as those who are pregnant or have received certain other medications for seizures. This trial is designed to help improve treatment options for a serious medical condition, and your participation could contribute to important findings in this area.

Gender

ALL

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