Epilepsy, Medically Resistant Status Epilepticus, Refractory Status Epilepticus, Seizure, Status Epilepticus
Conditions
Keywords
status epilepticus, seizure, epilepsy, ketogenic diet, modified Atkins diet
Brief summary
This research is being done to observe the safety, tolerability, side effects, and effectiveness of the ketogenic diet in people with continuous seizures (status epilepticus) being treated in a neurointensive care unit.
Interventions
DIETARY_SUPPLEMENTKetogenic diet
4:1 ratio fat: carbohydrates and protein ketogenic liquid via enteral feed
Sponsors
Mayo Clinic
Queen's Medical Center
Rush University Medical Center
Oregon Health and Science University
Thomas Jefferson University
Intermountain Medical Center
NYU Langone Health
University of Rochester
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients 18 years and older in refractory status epilepticus (continuous or recurrent seizures without return to baseline mental status between seizures, lasting \> 30 minutes) placed on anesthetics/sedating agents (barbiturates or benzodiazepines) after at least one first- and second-line agent failed to control seizures, and with clinical and/or electrographic seizures following attempt to wean anesthetic/sedating agents after 24 hours.
Exclusion criteria
1. Unstable metabolic condition 2. Hemodynamic or cardiorespiratory instability 3. Coagulopathy 4. Liver failure 5. Total cholesterol \> 300 mg/dL 6. Inability to tolerate enteral feeds, including ileus 7. Pregnancy 8. Family refusal/no consent 9. Received any propofol infusions within 24 hours 10. Known fatty acid oxidation disorder or pyruvate carboxylase deficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 2 weeks | Whether or not the diet protocol was followed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to seizure reduction | Participants will be followed for the duration of the hospital stay, an expected average of 6 weeks | The time (in days) from initiation of the diet to \> 50% reduction in frequency and to resolution of electrographic (based on continuous EEG findings) and/or clinical seizures will be recorded. |
| Ranking of tolerability measures on a 10 point scale | 6 months | Participants will complete a scale ranking convenience, taste, texture, tolerance |
| Number of participants with adverse events and description of events | 6 months | Reported side effects will be recorded as well as number of patients who develop side effects. |
| Time to achieving serum and/or urinary ketosis | Until serum or urinary ketosis is achieved, an expected average of 2 weeks | The time (in days) from starting the ketogenic diet to achieving urinary and/or serum ketosis will be recorded. |
Countries
United States
Outcome results
None listed