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

Johns Hopkins University8 sites in 1 country15 target enrollmentNovember 2012

ConditionsStatus Epilepticus Seizure Epilepsy Refractory Status Epilepticus Medically Resistant Status Epilepticus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Status Epilepticus
Sponsor: Johns Hopkins University
Enrollment: 15
Locations: 8
Primary Endpoint: Feasibility
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

March 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Principal Investigator

Mackenzie Cervenka

Assistant Professor of Neurology

Johns Hopkins University

Eligibility Criteria

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

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)