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Phase I/II multicenter ketogenic diet study for adult superrefractory status epilepticus.
- Source :
-
Neurology [Neurology] 2017 Mar 07; Vol. 88 (10), pp. 938-943. Date of Electronic Publication: 2017 Feb 08. - Publication Year :
- 2017
-
Abstract
- Objective: To investigate the feasibility, safety, and efficacy of a ketogenic diet (KD) for superrefractory status epilepticus (SRSE) in adults.<br />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.<br />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.<br />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.<br />Classification of Evidence: This study provides Class IV evidence that in adults with SRSE, a KD is effective in inducing ketosis.<br /> (© 2017 American Academy of Neurology.)
Details
- Language :
- English
- ISSN :
- 1526-632X
- Volume :
- 88
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Neurology
- Publication Type :
- Academic Journal
- Accession number :
- 28179470
- Full Text :
- https://doi.org/10.1212/WNL.0000000000003690