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

RECRUITING
I'm interested

1 year and over
This study is NOT accepting healthy volunteers
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

DRUG: Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET), DRUG: Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET), DRUG: Levetiracetam (LEV) (60 mg/Kg)

Status Epilepticus

Megan Wardius - mew5j@virginia.edu
NCT06907173

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