Ketogenic Diet for Refractory Status Epilepticus

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Johns Hopkins University
Mayo Clinic
Queen's Medical Centre
Rush University Medical Center
Oregon Health and Science University
Thomas Jefferson University
Intermountain Medical Center
New York University School of Medicine
University of Rochester
Information provided by (Responsible Party):
Mackenzie Cervenka, Johns Hopkins University Identifier:
First received: January 11, 2013
Last updated: February 24, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Status Epilepticus
Refractory Status Epilepticus
Medically Resistant Status Epilepticus
Dietary Supplement: Ketogenic diet
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility and Tolerability of the Ketogenic Diet in the Treatment of Refractory Status Epilepticus in a Neurointensive Care Unit.

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Whether or not the diet protocol was followed

Secondary Outcome Measures:
  • Time to seizure reduction [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Ranking of tolerability measures on a 10 point scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Participants will complete a scale ranking convenience, taste, texture, tolerance

  • Number of participants with adverse events and description of events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Reported side effects will be recorded as well as number of patients who develop side effects.

  • Time to achieving serum and/or urinary ketosis [ Time Frame: Until serum or urinary ketosis is achieved, an expected average of 2 weeks ] [ Designated as safety issue: No ]
    The time (in days) from starting the ketogenic diet to achieving urinary and/or serum ketosis will be recorded.

Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Dietary Supplement: Ketogenic diet
4:1 ratio fat: carbohydrates and protein ketogenic liquid via enteral feed
Other Name: KetoCal 4:1 liquid


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01796574

Contact: Mackenzie C. Cervenka, M.D. 443-287-0423 ext 3

United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Bhavesh Patel, M.D.    480-342-1386   
United States, Hawaii
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Matthew Koenig, M.D.    808-691-7152      
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Kelly Roehl, M.S., R.D.   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Mackenzie Cervenka   
Principal Investigator: Mackenzie C. Cervenka, MD         
Sub-Investigator: Eric H Kossoff, MD         
Sub-Investigator: Bobbie Henry, RD         
Sub-Investigator: Romer Geocadin, MD         
Sub-Investigator: Arun Venkatasan, MD         
Sub-Investigator: Adam Hartman, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sara E. Hocker, M.D.    507-774-4741   
Principal Investigator: Sara E. Hocker, MD         
United States, New York
New York University Recruiting
New York, New York, United States, 10016
Contact: Chong Derek, M.D.   
United States, Oregon
Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Holly Hinson, M.D.   
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Barak Bar, M.D.   
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Merin Kinikini, D.N.P, R.D.   
Sponsors and Collaborators
Johns Hopkins University
Mayo Clinic
Queen's Medical Centre
Rush University Medical Center
Oregon Health and Science University
Thomas Jefferson University
Intermountain Medical Center
New York University School of Medicine
University of Rochester
Principal Investigator: Mackenzie C. Cervenka, MD Johns Hopkins University
  More Information

Additional Information:

Responsible Party: Mackenzie Cervenka, Assistant Professor of Neurology, Johns Hopkins University Identifier: NCT01796574     History of Changes
Other Study ID Numbers: NA_00073063 
Study First Received: January 11, 2013
Last Updated: February 24, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
status epilepticus
ketogenic diet
modified Atkins diet

Additional relevant MeSH terms:
Status Epilepticus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on May 24, 2016