Status:
NOT_YET_RECRUITING
Ketamine for the Treatment of Refractory Status Epilepticus
Lead Sponsor:
Thomas Jefferson University
Conditions:
Refractory Status Epilepticus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This pilot feasibility study aims to examine how the timing of ketamine introduction as a third-line anti-seizure medication infusion relates to seizure cessation in patients with refractory status ep...
Detailed Description
Patients admitted to the Jefferson Neurological Intensive Care Unit with seizures or status epilepticus will be screened for eligibility. Surrogate consent will be obtained from the participants legal...
Eligibility Criteria
Inclusion
- Adults 18 years of age or older
- Patients with refractory status epilepticus unresponsive to appropriately dosed first line agents administered intravenous or intraosseous and one second line agent
- First line agents: lorazepam, midazolam, or diazepam
- Second line agents: phenytoin (20 mg/kg), valproate (40 mg/kg), levetiracetam (60 mg/kg), lacosamide (400 mg)
- All etiologies of status epilepticus will be included
Exclusion
- Exclusively psychogenic non epileptic seizures
- Pregnant individuals
- Incarcerated individuals
- Patients with hypersensitivity to ketamine or any component of the formulation
- Conditions in which an increase in blood pressure would be hazardous
- Focal motor status epilepticus
- Status epilepticus lasting \> 24 hours prior to enrollment (SRSE)
- Patients with EEG in the ictal-interictal continuum (IIC)
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07177235
Start Date
November 1 2025
End Date
July 1 2028
Last Update
September 16 2025
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107