Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2012-11-30
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Ketogenic diet
4:1 ratio fat: carbohydrates and protein ketogenic liquid via enteral feed
Interventions
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Ketogenic diet
4:1 ratio fat: carbohydrates and protein ketogenic liquid via enteral feed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
80 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Queen's Medical Center
OTHER
Rush University Medical Center
OTHER
Oregon Health and Science University
OTHER
Thomas Jefferson University
OTHER
Intermountain Medical Center
OTHER
NYU Langone Health
OTHER
University of Rochester
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Mackenzie Cervenka
Assistant Professor of Neurology
Principal Investigators
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Mackenzie C. Cervenka, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Mayo Clinic
Phoenix, Arizona, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Rush University Medical Center
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
New York University
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Intermountain Medical Center
Murray, Utah, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Adult Epilepsy Diet Center at Hopkins website
Other Identifiers
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NA_00073063
Identifier Type: -
Identifier Source: org_study_id
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