Ketogenic Diet for Refractory Status Epilepticus

Not Applicable

Completed

• Conditions: Refractory Status Epilepticus; Medically Resistant Status Epilepticus; Seizure; Status Epilepticus; Epilepsy
• Interventions: Dietary Supplement: Ketogenic diet

• Registration Number: NCT01796574
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-22
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-12
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketogenic diet	Ketogenic diet	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.

Primary Outcome Measures

Name	Time	Method
Feasibility	2 weeks	Whether or not the diet protocol was followed

Secondary Outcome Measures

Name	Time	Method
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.
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 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

Trial Locations

Locations (8)

Queen's Medical Center; 🇺🇸 Honolulu, Hawaii, United States

New York University; 🇺🇸 New York, New York, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States