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临床试验/NCT02174016
NCT02174016暂停不适用

The Ketogenic Diet for Pediatric Acute Brain Injury

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2015年1月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joyce Matsumoto

Health Sciences Assistant Clinical Professor

University of California, Los Angeles

研究点 (2)

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