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Ketogenic Diet for Refractory Status Epilepticus

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01796574
First received: January 11, 2013
Last updated: March 12, 2017
Last verified: March 2017
  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
Status Epilepticus
Seizure
Epilepsy
Refractory Status Epilepticus
Medically Resistant Status Epilepticus
Dietary Supplement: Ketogenic diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 ]
    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 ]
    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 ]
    Participants will complete a scale ranking convenience, taste, texture, tolerance

  • 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.

  • 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.


Enrollment: 15
Study Start Date: November 2012
Study Completion Date: March 2017
Primary Completion Date: March 2017 (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 to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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. 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 ClinicalTrials.gov identifier: NCT01796574

Locations
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, Hawaii
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
New York University
New York, New York, United States, 10016
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
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
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: March 12, 2017

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 May 23, 2017