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Ketogenic Diet for Refractory Status Epilepticus

Primary Purpose

Status Epilepticus, Seizure, Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketogenic diet
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status Epilepticus focused on measuring status epilepticus, seizure, epilepsy, ketogenic diet, modified Atkins diet

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic
  • Queen's Medical Center
  • Rush University Medical Center
  • Johns Hopkins University
  • Mayo Clinic
  • New York University
  • Oregon Health & Science University
  • Thomas Jefferson University
  • Intermountain Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketogenic diet

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility
Whether or not the diet protocol was followed

Secondary Outcome Measures

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.
Ranking of tolerability measures on a 10 point scale
Participants will complete a scale ranking convenience, taste, texture, tolerance
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.
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.

Full Information

First Posted
January 11, 2013
Last Updated
March 12, 2017
Sponsor
Johns Hopkins University
Collaborators
Mayo Clinic, Queen's Medical Center, Rush University Medical Center, Oregon Health and Science University, Thomas Jefferson University, Intermountain Medical Center, NYU Langone Health, University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT01796574
Brief Title
Ketogenic Diet for Refractory Status Epilepticus
Official Title
Feasibility and Tolerability of the Ketogenic Diet in the Treatment of Refractory Status Epilepticus in a Neurointensive Care Unit.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Mayo Clinic, Queen's Medical Center, Rush University Medical Center, Oregon Health and Science University, Thomas Jefferson University, Intermountain Medical Center, NYU Langone Health, University of Rochester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus, Seizure, Epilepsy, Refractory Status Epilepticus, Medically Resistant Status Epilepticus
Keywords
status epilepticus, seizure, epilepsy, ketogenic diet, modified Atkins diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic diet
Other Intervention Name(s)
KetoCal 4:1 liquid
Intervention Description
4:1 ratio fat: carbohydrates and protein ketogenic liquid via enteral feed
Primary Outcome Measure Information:
Title
Feasibility
Description
Whether or not the diet protocol was followed
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Time to seizure reduction
Description
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.
Time Frame
Participants will be followed for the duration of the hospital stay, an expected average of 6 weeks
Title
Ranking of tolerability measures on a 10 point scale
Description
Participants will complete a scale ranking convenience, taste, texture, tolerance
Time Frame
6 months
Title
Number of participants with adverse events and description of events
Description
Reported side effects will be recorded as well as number of patients who develop side effects.
Time Frame
6 months
Title
Time to achieving serum and/or urinary ketosis
Description
The time (in days) from starting the ketogenic diet to achieving urinary and/or serum ketosis will be recorded.
Time Frame
Until serum or urinary ketosis is achieved, an expected average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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: Unstable metabolic condition Hemodynamic or cardiorespiratory instability Coagulopathy Liver failure Total cholesterol > 300 mg/dL Inability to tolerate enteral feeds, including ileus Pregnancy Family refusal/no consent Received any propofol infusions within 24 hours Known fatty acid oxidation disorder or pyruvate carboxylase deficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mackenzie C. Cervenka, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22718405
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.
Results Reference
background
PubMed Identifier
22577217
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. Epub 2012 May 9. Erratum In: Brain. 2013 Jul;136(Pt 7):2326.
Results Reference
background
PubMed Identifier
22003821
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. Epub 2011 Oct 17.
Results Reference
background
PubMed Identifier
20813015
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. Epub 2010 Aug 31.
Results Reference
background
PubMed Identifier
21523523
Citation
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.
Results Reference
background
PubMed Identifier
19845731
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. Epub 2009 Oct 20.
Results Reference
background
PubMed Identifier
24453083
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. Epub 2014 Jan 22.
Results Reference
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Links:
URL
http://www.hopkinsmedicine.org/neurology_neurosurgery/specialty_areas/epilepsy/adult/adult-epilepsy-diet-center/
Description
Adult Epilepsy Diet Center at Hopkins website

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Ketogenic Diet for Refractory Status Epilepticus

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