Ketogenic Diet for Refractory Status Epilepticus

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility and Tolerability of the Ketogenic Diet in the Treatment of Refractory Status Epilepticus in a Neurointensive Care Unit.

Conditions
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Status Epilepticus, Seizure, Epilepsy, Refractory Status Epilepticus, Medically Resistant Status Epilepticus

Intervention / Treatment
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* Dietary Supplement: Ketogenic diet


Participation Criteria
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Eligibility Criteria
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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: Unstable metabolic condition Hemodynamic or cardiorespiratory instability Coagulopathy Liver failure Total cholesterol > 300 mg/dL Inability to tolerate enteral feeds, including ileus Pregnancy Family refusal/no consent Received any propofol infusions within 24 hours Known fatty acid oxidation disorder or pyruvate carboxylase deficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic diet<br>Patients will receive the ketogenic diet as a formula delivered via feeding tube. Once able to tolerate food by mouth, patients will be switched to a modified Atkins diet. | Dietary Supplement: Ketogenic diet<br>* 4:1 ratio fat: carbohydrates and protein ketogenic liquid via enteral feed<br>* Other names: KetoCal 4:1 liquid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Whether or not the diet protocol was followed | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to seizure reduction | 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. | Participants will be followed for the duration of the hospital stay, an expected average of 6 weeks | 
| Ranking of tolerability measures on a 10 point scale | Participants will complete a scale ranking convenience, taste, texture, tolerance | 6 months | 
| Number of participants with adverse events and description of events | Reported side effects will be recorded as well as number of patients who develop side effects. | 6 months | 
| Time to achieving serum and/or urinary ketosis | The time (in days) from starting the ketogenic diet to achieving urinary and/or serum ketosis will be recorded. | Until serum or urinary ketosis is achieved, an expected average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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status epilepticus, seizure, epilepsy, ketogenic diet, modified Atkins diet