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临床试验/NCT00181753
NCT00181753撤回不适用

Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition

Massachusetts General Hospital1 个研究点 分布在 1 个国家开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
This is a nutritional study. The primary outcome is to measure the protein kinetics for metabolism of the amino acid, glutamate and glutamine. Fate will be determine from measurements of subject blood and air samples.

研究概览

简要总结

The purpose of the study is to understand how the body uses amino acids in burned patients during the time they cannot eat normally. Amino acids occur naturally in the body and the food we eat. The body combines amino acids to make protein. It uses the proteins to do things such as heal wounds, fight infection, and provide energy. We are studying two ways of receiving nutrition: through a vein or through a tube. We are also studying two different types of food: with or without glutamine. The results of this study will be used to determine the best type and way to supply nutrients during a severe burn injury. We hope to learn how to help the body use nutrients more efficiently to better repair wounded tissues and recover earlier from injury.

详细描述

We hypothesize that:

  1. Burn patients will experience an increased conversion of glutamine to glutamate and a decreased conversion of glutamate to glutamine as compared to healthy subjects. The net direction is from glutamine to glutamate in burn patients and would render glutamine as a conditionally essential amino acid.
  2. Because of the limited ability of liver to oxidize glutamate, it is possible that large doses of glutamine may cause increased gluconeogenesis in burn patients, thus aggravating the glucose homeostasis secondary to insulin resistance.
  3. Enterally and parenterally fed glutamine and glutamate have different metabolic fate in the splanchnic bed and peripheral regions, therefore the doses should be tailored according to the route of administration.

This study, using stable isotope tracers, aims to track the metabolic fate of glutamine and glutamate in body with the goal of enhancing nutritional efficiency.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • One or more of the following:
  • 5% Total Body Surface Area Thermal Burn
  • Inhalation Injury
  • Resting Energy Expenditure of >15% of the predicted Basal Metabolic Rate Using Harris-Benedict.
  • Receiving Enteral or Parental Nutritional Support

排除标准

  • Pre-existing:
  • Thyroid disease
  • Congestive Heart Failure (Ejection fraction <20%)
  • Malignancy currently under treatment
  • Medical conditions requiring glucocorticoid treatment
  • Decision not to treat because of severity of injury
  • Presence of Anoxic brain injury with no expectation for recovery
  • Self-Inflicted thermal injury
  • Ileus, gut paralysis, or facial injuries
  • No NG or OG tube as part of their clinical care

研究组 & 干预措施

1

Experimental

Burn Patients receiving at least 3 days of parenteral feeding on routine formula

干预措施: standard vs. glutamine enteral or parenteral feeding. (Drug)

1

Experimental

Burn Patients receiving at least 3 days of parenteral feeding on routine formula

干预措施: Stable isotope tracer study (Dietary Supplement)

1

Experimental

Burn Patients receiving at least 3 days of parenteral feeding on routine formula

干预措施: Stable isotope study (Dietary Supplement)

2

Experimental

Burn patients receiving at least 3 days on parenteral feeding on glutamine enriched formula.

干预措施: standard vs. glutamine enteral or parenteral feeding. (Drug)

2

Experimental

Burn patients receiving at least 3 days on parenteral feeding on glutamine enriched formula.

干预措施: Stable isotope tracer study (Dietary Supplement)

2

Experimental

Burn patients receiving at least 3 days on parenteral feeding on glutamine enriched formula.

干预措施: Stable isotope study (Dietary Supplement)

3

Experimental

Burn patients receiving at least 3 days of enteral feeding on routine formula.

干预措施: standard vs. glutamine enteral or parenteral feeding. (Drug)

3

Experimental

Burn patients receiving at least 3 days of enteral feeding on routine formula.

干预措施: Stable isotope tracer study (Dietary Supplement)

3

Experimental

Burn patients receiving at least 3 days of enteral feeding on routine formula.

干预措施: Stable isotope study (Dietary Supplement)

4

Experimental

Burn patients receiving at least 3 days of enteral feeding on glutamine-enriched formula.

干预措施: standard vs. glutamine enteral or parenteral feeding. (Drug)

4

Experimental

Burn patients receiving at least 3 days of enteral feeding on glutamine-enriched formula.

干预措施: Stable isotope tracer study (Dietary Supplement)

4

Experimental

Burn patients receiving at least 3 days of enteral feeding on glutamine-enriched formula.

干预措施: Stable isotope study (Dietary Supplement)

结局指标

主要结局

This is a nutritional study. The primary outcome is to measure the protein kinetics for metabolism of the amino acid, glutamate and glutamine. Fate will be determine from measurements of subject blood and air samples.

时间窗: 3 days and above

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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