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

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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)938-943
Number of pages6
JournalNeurology
Volume88
Issue number10
DOIs
StatePublished - Mar 7 2017

ASJC Scopus subject areas

  • Clinical Neurology

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