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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01796574
Other study ID # NA_00073063
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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