Ketogenic Diet for Refractory Status Epilepticus

Epilepsy Clinical Trial

Official title:

Feasibility and Tolerability of the Ketogenic Diet in the Treatment of Refractory Status Epilepticus in a Neurointensive Care Unit.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796574
• Other study ID #: NA_00073063
• Status: Completed
• Phase: N/A
• First received: January 11, 2013
• Last updated: March 12, 2017
• Start date: November 2012
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Medically Resistant Status Epilepticus
• Refractory Status Epilepticus
• Seizure
• Seizures
• Status Epilepticus

Intervention

Dietary Supplement:
• Ketogenic diet
4:1 ratio fat: carbohydrates and protein ketogenic liquid via enteral feed

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Rush University Medical Center	Chicago	Illinois
United States	Queen's Medical Center	Honolulu	Hawaii
United States	Intermountain Medical Center	Murray	Utah
United States	New York University	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Mayo Clinic	Phoenix	Arizona
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (9)

Lead Sponsor	Collaborator
Johns Hopkins University	Intermountain Medical Center, Mayo Clinic, New York University School of Medicine, Oregon Health and Science University, Queen's Medical Centre, Rush University Medical Center, Thomas Jefferson University, University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. Review. Erratum in: Brain. 2013 Jul;136(Pt 7):2326. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Whether or not the diet protocol was followed	2 weeks
Secondary	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
Secondary	Ranking of tolerability measures on a 10 point scale	Participants will complete a scale ranking convenience, taste, texture, tolerance	6 months
Secondary	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
Secondary	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

External Links

•   Adult Epilepsy Diet Center at Hopkins website