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临床试验/NCT00067132
NCT00067132已完成1 期

Adjuvant Nutrition for Critically Ill Trauma Patients

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003年3月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
100
试验地点
2

研究概览

简要总结

Of the four million trauma cases each year that will require hospitalization, 200,000 will be classified as severe trauma. During the hospital stay, malnutrition is a major complication in about 50% of the patient population. The result is muscle wasting which is a major risk factor for increased morbidity and mortality. In this study we postulate that supplementation with beta-hydroxy-beta-methylbutyrate (HMB), arginine and glutamine (HMB/Arg/Gln)or HMB alone to these severely traumatized patients can stem the loss of muscle tissue and whole body nitrogen and in turn decrease morbidity and mortality. This hypothesis is based on two recent studies showing the same nutritional mixture of HMB/Arg/Gln can reverse the muscle wasting associated with AIDS and Cancer. The hypermetabolic state seen in AIDS and cancer have a similar multifactorial etiology as seen in trauma. There is an increase in the mobilization of fat and muscle, increased or normal metabolic rate, increased protein breakdown, and an increased or normal glucose turnover. In addition, HMB alone has been shown to reduce nitrogen loss, decrease muscle proteolysis and muscle damage within the first 48 hours to three weeks after initiating supplementation during a strenuous exercise program. Male and female patients (n=100) will be recruited at the time of admittance to the Trauma ICU with an ISS of greater than 18. Patients who meet the inclusion/exclusion criteria will be randomized to receive either 1) standard tube feed plus HMB/Arg/Gln, 2) standard tube feed plus HMB alone, or 3)standard tube feed (control) in a double-blinded fashion. Clinical outcomes measures will be assessed through out the hospital stay and on an outpatient basis at weeks 4 and 12. Muscle proteolysis and nitrogen economy will be evaluated on daily basis while in the hospital and after 4 weeks on an out patient basis. If as expected, Phase I results confirm the effectiveness of the nutrient mixture in trauma patients, expanded multicenter studies will be proposed in Phase II.

详细描述

OBJECTIVES:

To compare the effectiveness of immediate nutritional intervention with either HMB, arginine, and glutamine or HMB alone with that of a placebo supplement in critically ill trauma patients on:

  • decreasing muscle protein turnover and nitrogen loss
  • improving nutritional status,
  • improving clinical outcomes,
  • preventing total body weight and skeletal muscle loss and
  • improving immune status

OUTLINE:

This is a double blind, placebo-controlled randomized clinical study. After receiving informed consent for participation in the study from the next of kin, patients will be randomly assigned to one of the 3 treatment arms:

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
Double

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

研究点 (2)

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