Summary

Eligibility
for people ages 1-17 (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Joyce Matsumoto

Description

Summary

This is a prospective pilot study evaluating the safety and feasibility of implementing the ketogenic diet in children admitted to the pediatric intensive care unit with acute brain injury such as stroke, traumatic brain injury, and intracerebral hemorrhage. Animal studies suggest that in the aftermath of injury the brain's ability to use glucose as a fuel is impaired. The ketogenic diet is a high fat, low carbohydrate diet which is already used in clinical practice for the treatment of medication resistant epilepsy and is intended to switch the body over to burning fat rather than carbohydrates for fuel. In lieu of their standard tube-feeds, 5-10 children admitted to the PICU with these diagnoses will receive low carbohydrate, high fat ketogenic feeds for 2 weeks. We hypothesize that ketones will be detectable through serum tests and MRI spectroscopy studies of the brain within several days of diet initiation, and that there will be a low incidence of side effects and adverse events,

Measures of interest will include the incidence of kidney stones, excessive acidosis and excessive hypoglycemia. The feasibility of implementing this protocol for a larger efficacy trial will be assessed through serial measurements of blood glucose, beta-hydroxybutyrate (a type of ketone body), and serum bicarbonate levels. In addition, levels of ketone bodies within the brain will be measured through MRI spectroscopy sequence which will be acquired at the same time as a follow-up MRI brain study ordered for clinical purposes.

Keywords

Acute Brain Injuries, Intensive Care Units, Pediatric, Brain Injuries, Wounds and Injuries, Ketogenic diet

Eligibility

You can join if…

Open to people ages 1-17

children age -17 years admitted to the pediatric intensive care unit with acute brain injury such as acute stroke, severe traumatic brain injury, and intracerebral hemorrhage

You CAN'T join if...

  1. True milk allergy (anaphylaxis or severe rash)
  2. Significant gastrointestinal injury precluding enteral feeding
  3. Hepatic or renal insufficiency
  4. History of nephrolithiasis
  5. Severe acidosis (serum bicarbonate ≤ 17 mEq/L) resistant to correction
  6. History of inborn error of metabolism
  7. Preexisting epilepsy or developmental delay

Location

  • Ronald Reagan UCLA Medical Center
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Joyce Matsumoto
    HS Clinical Professor, Pediatrics, Medicine. Authored (or co-authored) 30 research publications

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT02174016
Study Type
Interventional
Participants
Expecting 5 study participants
Last Updated