Phase I/II multicenter ketogenic diet study for adult superrefractory status epilepticus.

Abstract

OBJECTIVE:

To investigate the feasibility, safety, and efficacy of a ketogenic diet (KD) for superrefractory status epilepticus (SRSE) in adults.

METHODS:

We performed a prospective multicenter study of patients 18 to 80 years of age with SRSE treated with a KD treatment algorithm. The primary outcome measure was significant urine and serum ketone body production as a biomarker of feasibility. Secondary measures included resolution of SRSE, disposition at discharge, KD-related side effects, and long-term outcomes.

RESULTS:

Twenty-four adults were screened for participation at 5 medical centers, and 15 were enrolled and treated with a classic KD via gastrostomy tube for SRSE. Median age was 47 years (interquartile range [IQR] 30 years), and 5 (33%) were male. Median number of antiseizure drugs used before KD was 8 (IQR 7), and median duration of SRSE before KD initiation was 10 days (IQR 7 days). KD treatment delays resulted from intravenous propofol use, ileus, and initial care received at a nonparticipating center. All patients achieved ketosis in a median of 2 days (IQR 1 day) on KD. Fourteen patients completed KD treatment, and SRSE resolved in 11 (79%; 73% of all patients enrolled). Side effects included metabolic acidosis, hyperlipidemia, constipation, hypoglycemia, hyponatremia, and weight loss. Five patients (33%) ultimately died.

CONCLUSIONS:

KD is feasible in adults with SRSE and may be safe and effective. Comparative safety and efficacy must be established with randomized placebo-controlled trials.

CLASSIFICATION OF EVIDENCE:

This study provides Class IV evidence that in adults with SRSE, a KD is effective in inducing ketosis.

• Authors: Mackenzie C Cervenka, Sara Hocker, Matthew Koenig, Barak Bar, Bobbie Henry-Barron, Eric H Kossoff, Adam L Hartman, John C Probasco, David R Benavides, Arun Venkatesan, Eliza C Hagen, Denise Dittrich, Tracy Stern, Batya Radzik, Marie Depew, Filissa M Caserta, Paul Nyquist, Peter W Kaplan, Romergryko G Geocadin
• Journal: Neurology (Neurology) Vol. 88 Issue 10 Pg. 938-943 (Mar 07 2017) ISSN: 1526-632X [Electronic] United States
• PMID: 28179470 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: © 2017 American Academy of Neurology.

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Diet, Ketogenic (methods)
• Female
• Humans
• Male
• Middle Aged
• Prospective Studies
• Severity of Illness Index
• Status Epilepticus (diet therapy)
• Treatment Outcome
• Young Adult