NCT01796574CompletedNot Applicable
Feasibility and Tolerability of the Ketogenic Diet in the Treatment of Refractory Status Epilepticus in a Neurointensive Care Unit.
Johns Hopkins University9 sites in 1 country15 target enrollmentStarted: November 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 15
- Locations
- 9
- Primary Endpoint
- Feasibility
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Unstable metabolic condition
- •Hemodynamic or cardiorespiratory instability
- •Coagulopathy
- •Liver failure
- •Total cholesterol > 300 mg/dL
- •Inability to tolerate enteral feeds, including ileus
- •Family refusal/no consent
- •Received any propofol infusions within 24 hours
- •Known fatty acid oxidation disorder or pyruvate carboxylase deficiency
Arms & Interventions
Ketogenic diet
Experimental
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.
Intervention: Ketogenic diet (Dietary Supplement)
Outcomes
Primary Outcomes
Feasibility
Time Frame: 2 weeks
Whether or not the diet protocol was followed
Secondary Outcomes
- Time to achieving serum and/or urinary ketosis(Until serum or urinary ketosis is achieved, an expected average of 2 weeks)
- Time to seizure reduction(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(6 months)
- Number of participants with adverse events and description of events(6 months)
Investigators
Mackenzie Cervenka
Assistant Professor of Neurology
Johns Hopkins University
Study Sites (9)
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