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Completed

NCT Number: NCT01796574

Ketogenic Diet for Refractory Status Epilepticus

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.

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Key information

Conditions

Status Epilepticus Brain Diseases Central Nervous System Diseases Epilepsy Medically Resistant Status Epilepticus Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Refractory Status Epilepticus Seizure Seizures Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketogenic diet

Dietary Supplement

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

Other names: KetoCal 4:1 liquid

Primary outcomes

  1. Feasibility

    Time frame: 2 weeks

    Whether or not the diet protocol was followed

Secondary outcomes

  1. 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.

  2. Ranking of tolerability measures on a 10 point scale

    Time frame: 6 months

    Participants will complete a scale ranking convenience, taste, texture, tolerance

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Feb 22, 2013
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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