Clinical trial NCT01796574: Ketogenic Diet for Refractory Status Epilepticus
Official title: Feasibility and Tolerability of the Ketogenic Diet in the Treatment of Refractory Status Epilepticus in a Neurointensive Care Unit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Status Epilepticus
Seizure
Epilepsy
Refractory Status Epilepticus
Medically Resistant Status Epilepticus
Keywords: status epilepticus
seizure
epilepsy
ketogenic diet
modified Atkins diet
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Queen's Medical Center
name: Rush University Medical Center
name: Oregon Health and Science University
name: Thomas Jefferson University
name: Intermountain Medical Center
name: NYU Langone Health
name: University of Rochester
First posted: 2013-02-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

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

Primary outcomes:
measure: Feasibility
timeFrame: 2 weeks
Secondary outcomes:
measure: Time to seizure reduction
timeFrame: Participants will be followed for the duration of the hospital stay, an expected average of 6 weeks
measure: Ranking of tolerability measures on a 10 point scale
timeFrame: 6 months
measure: Number of participants with adverse events and description of events
timeFrame: 6 months
measure: Time to achieving serum and/or urinary ketosis
timeFrame: Until serum or urinary ketosis is achieved, an expected average of 2 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York University
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Johns Hopkins University
name: Mackenzie C. Cervenka, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaccarezza M, Silva W, Maxit C, Agosta G. [Super-refractory status epilepticus: treatment with ketogenic diet in pediatrics]. Rev Neurol. 2012 Jul 1;55(1):20-5. Spanish.
citation: Ferlisi M, Shorvon S. The outcome of therapies in refractory and super-refractory convulsive status epilepticus and recommendations for therapy. Brain. 2012 Aug;135(Pt 8):2314-28. doi: 10.1093/brain/aws091. Epub 2012 May 9.
citation: Nam SH, Lee BL, Lee CG, Yu HJ, Joo EY, Lee J, Lee M. The role of ketogenic diet in the treatment of refractory status epilepticus. Epilepsia. 2011 Nov;52(11):e181-4. doi: 10.1111/j.1528-1167.2011.03289.x. Epub 2011 Oct 17.
citation: Nabbout R, Mazzuca M, Hubert P, Peudennier S, Allaire C, Flurin V, Aberastury M, Silva W, Dulac O. Efficacy of ketogenic diet in severe refractory status epilepticus initiating fever induced refractory epileptic encephalopathy in school age children (FIRES). Epilepsia. 2010 Oct;51(10):2033-7. doi: 10.1111/j.1528-1167.2010.02703.x. Epub 2010 Aug 31.
citation: Cervenka MC, Hartman AL, Venkatesan A, Geocadin RG, Kossoff EH. The ketogenic diet for medically and surgically refractory status epilepticus in the neurocritical care unit. Neurocrit Care. 2011 Dec;15(3):519-24. doi: 10.1007/s12028-011-9546-3.
citation: Wusthoff CJ, Kranick SM, Morley JF, Christina Bergqvist AG. The ketogenic diet in treatment of two adults with prolonged nonconvulsive status epilepticus. Epilepsia. 2010 Jun;51(6):1083-5. doi: 10.1111/j.1528-1167.2009.02388.x. Epub 2009 Oct 20.
citation: Thakur KT, Probasco JC, Hocker SE, Roehl K, Henry B, Kossoff EH, Kaplan PW, Geocadin RG, Hartman AL, Venkatesan A, Cervenka MC. Ketogenic diet for adults in super-refractory status epilepticus. Neurology. 2014 Feb 25;82(8):665-70. doi: 10.1212/WNL.0000000000000151. Epub 2014 Jan 22.