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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| Queen's Medical Center | OTHER |
| Rush University Medical Center | OTHER |
| Oregon Health and Science University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic diet | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic diet | Dietary Supplement | 4:1 ratio fat: carbohydrates and protein ketogenic liquid via enteral feed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Whether or not the diet protocol was followed | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to seizure reduction | The time (in days) from initiation of the diet to > 50% reduction in frequency and to resolution of electrographic (based on continuous EEG findings) and/or clinical seizures will be recorded. | Participants will be followed for the duration of the hospital stay, an expected average of 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mackenzie C. Cervenka, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| Queen's Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22718405 | Background | 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. | |
| 22577217 | Background | 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. |
| Label | URL |
|---|---|
| Adult Epilepsy Diet Center at Hopkins website | View source |
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| OTHER |
| Thomas Jefferson University | OTHER |
| Intermountain Health Care, Inc. | OTHER |
| NYU Langone Health | OTHER |
| University of Rochester | OTHER |
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| Ranking of tolerability measures on a 10 point scale |
Participants will complete a scale ranking convenience, taste, texture, tolerance |
| 6 months |
| Number of participants with adverse events and description of events | Reported side effects will be recorded as well as number of patients who develop side effects. | 6 months |
| Time to achieving serum and/or urinary ketosis | The time (in days) from starting the ketogenic diet to achieving urinary and/or serum ketosis will be recorded. | Until serum or urinary ketosis is achieved, an expected average of 2 weeks |
| Honolulu |
| Hawaii |
| 96813 |
| United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| New York University | New York | New York | 10016 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| 22003821 | Background | 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. |
| 20813015 | Background | 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. |
| 21523523 | Background | 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. |
| 19845731 | Background | 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. |
| 24453083 | Background | 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. |
| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| D012640 | Seizures |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D004358 | Drug Therapy |
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