The Ketogenic Diet for Pediatric Acute Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Increase in Beta-hydroxybutyrate level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •True milk allergy (anaphylaxis or severe rash)
- •Significant gastrointestinal injury precluding enteral feeding
- •Hepatic or renal insufficiency
- •History of nephrolithiasis
- •Severe acidosis (serum bicarbonate ≤ 17 mEq/L) resistant to correction
- •History of inborn error of metabolism
- •Preexisting epilepsy or developmental delay
结局指标
主要结局
Increase in Beta-hydroxybutyrate level
时间窗: 2 weeks
Serum beta hydroxybutyrate levels will be checked daily, in order to determine how many days it will take to achieve elevated levels.
次要结局
- Number of episodes of low blood glucose levels(2 weeks)
- Number of episodes of low serum bicarbonate levels(2 weeks)
- Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds,(5 days)
- Number of subjects who develop kidney stones(2 weeks)
研究者
Joyce Matsumoto
Health Sciences Assistant Clinical Professor
University of California, Los Angeles
