Ketogenic Diet for Refractory Status Epilepticus

Johns Hopkins University15 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Status Epilepticus Seizure Epilepsy Refractory Status Epilepticus Medically Resistant Status Epilepticus

Interventions

Ketogenic dietDIETARY_SUPPLEMENT

4:1 ratio fat: carbohydrates and protein ketogenic liquid via enteral feed

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (9)

Mayo Clinic

Phoenix, Arizona, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Rush University Medical Center

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Feasibility

Whether or not the diet protocol was followed

Time frame: 2 weeks

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Until serum or urinary ketosis is achieved, an expected average of 2 weeks

Data from ClinicalTrials.gov

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