Ketogenic Diet for Refractory Status Epilepticus

March 12, 2017 updated by: Mackenzie Cervenka, Johns Hopkins University

Feasibility and Tolerability of the Ketogenic Diet in the Treatment of Refractory Status Epilepticus in a Neurointensive Care Unit.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10016
        • New York University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Utah
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • KetoCal 4:1 liquid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 2 weeks
Whether or not the diet protocol was followed
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to seizure reduction
Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 6 weeks
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
Ranking of tolerability measures on a 10 point scale
Time Frame: 6 months
Participants will complete a scale ranking convenience, taste, texture, tolerance
6 months
Number of participants with adverse events and description of events
Time Frame: 6 months
Reported side effects will be recorded as well as number of patients who develop side effects.
6 months
Time to achieving serum and/or urinary ketosis
Time Frame: Until serum or urinary ketosis is achieved, an expected average of 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Mayo Clinic
NYU Langone Health
Rush University Medical Center
Oregon Health and Science University
University of Rochester
Thomas Jefferson University
Queen's Medical Center
Intermountain Medical Center

Investigators

  • Principal Investigator: Mackenzie C. Cervenka, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

January 11, 2013

First Submitted That Met QC Criteria

February 19, 2013

First Posted (Estimate)

February 22, 2013

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 12, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00073063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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