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

RecruitingPhase 3Ages 1 Year - anyAllUniversity of Virginia
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ10 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
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What it tests

  • 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)
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Where

63 sites
UAB Hospital
Birmingham, United States
Banner University Medical Center - Tucson Campus
Tucson, United States
UC San Diego Health La Jolla
La Jolla, United States
Ronald Reagan UCLA Medical Center
Los Angeles, United States
Children's Hospital Los Angeles
Los Angeles, United States
Stanford University Medical Center
Palo Alto, United States
UC Davis Medical Center
Sacramento, United States
UC San Diego Health Hillcrest Hospital
San Diego, United States

โ€ฆand 55 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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