NCT01796574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

4.3 years

First QC Date

January 11, 2013

Last Update Submit

March 12, 2017

Conditions

Status EpilepticusSeizureEpilepsyRefractory Status EpilepticusMedically Resistant Status Epilepticus

Keywords

status epilepticusseizureepilepsyketogenic dietmodified Atkins diet

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    Whether or not the diet protocol was followed

    2 weeks

Secondary Outcomes (4)

  • Time to seizure reduction

    Participants will be followed for the duration of the hospital stay, an expected average of 6 weeks

  • Ranking of tolerability measures on a 10 point scale

    6 months

  • Number of participants with adverse events and description of events

    6 months

  • Time to achieving serum and/or urinary ketosis

    Until serum or urinary ketosis is achieved, an expected average of 2 weeks

Study Arms (1)

Ketogenic diet

EXPERIMENTAL

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

Interventions

Ketogenic dietDIETARY_SUPPLEMENT

4:1 ratio fat: carbohydrates and protein ketogenic liquid via enteral feed

Also known as: KetoCal 4:1 liquid
Ketogenic diet

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York University

New York, New York, 10016, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Related Publications (7)

  • 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.

    PMID: 22718405BACKGROUND

  • 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.

    PMID: 22577217BACKGROUND

  • 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.

    PMID: 22003821BACKGROUND

  • 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.

    PMID: 20813015BACKGROUND

  • 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.

    PMID: 21523523BACKGROUND

  • 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.

    PMID: 19845731BACKGROUND

  • 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.

    PMID: 24453083BACKGROUND

Related Links

MeSH Terms

Conditions

Status EpilepticusSeizuresEpilepsy

Interventions

Diet, KetogenicFluid Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDrug Therapy

Study Officials

  • Mackenzie C. Cervenka, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

January 11, 2013

First Posted

February 22, 2013

Study Start

November 1, 2012

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

US(9)