Ketogenic Diet for Refractory Status Epilepticus

This study is currently recruiting participants.
Verified February 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Mackenzie Cervenka, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01796574
First received: January 11, 2013
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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
Seizure
Epilepsy
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: 10
Study Start Date: November 2012
Estimated Primary Completion Date: November 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. Receiving hemodialysis or plasmapheresis
  11. Known fatty acid oxidation disorder or pyruvate carboxylase deficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796574

Contacts
Contact: Mackenzie C. Cervenka, M.D. 443-287-0423 ext 3 mcerven1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Mackenzie Cervenka       mcerven1@jhmi.edu   
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    hocker.sara@mayo.edu   
Principal Investigator: Sara E. Hocker, MD         
Sponsors and Collaborators
Johns Hopkins University
Mayo Clinic
Investigators
Principal Investigator: Mackenzie C. Cervenka, MD Johns Hopkins University
  More Information

Additional Information:
Publications:

Responsible Party: Mackenzie Cervenka, Assistant Professor of Neurology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01796574     History of Changes
Other Study ID Numbers: NA_00073063
Study First Received: January 11, 2013
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Epilepsy
Seizures
Status Epilepticus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014