Adjuvant Nutrition for Critically III Trauma Patients

危重 III 级创伤患者的辅助营养

• 批准号: 6582697
• 负责人: John A Rathmacher
• 金额: $ 10万
• 依托单位: METABOLIC TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-02-01 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6582697
• 关键词: arginine; atrophy; carboxylate; clinical research; critical care; dietary supplements; glutamine; human subject; human therapy evaluation; malnutrition; nitrogen metabolism; nutrition related tag; outcomes research; parenteral feedings; patient oriented research; proteolysis; sarcopenia; trauma; arginine; atrophy; carboxylate; clinical research; critical care; dietary supplements; glutamine; human subject; human therapy evaluation; malnutrition; nitrogen metabolism; nutrition related tag; outcomes research; parenteral feedings; patient oriented research; proteolysis; sarcopenia; trauma

DESCRIPTION (provided by applicant): Of the four million cases of 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 the study proposal presented we postulate that supplementation with Beta-hydroxy-Beta-methylbutyrate (HMB), arginine and glutamine (HMB/Arg/Gln) 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 multilifactorial etiology 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 week after initiating supplementation. 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 will be randomized to receive either 1) standard tube feed plus HMB/Arg/Gln, standard tube feed plus HMB alone, or standard tube feed (control) in a blinded fashion. Clinical outcomes measures will be assessed through out the hospital stay and on a outpatient basis on week 4 and week 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.

描述（由申请人提供）：每年需要住院的创伤病例中有400万例，将有200,000例被归类为严重的创伤。在住院期间，营养不良是大约50％患者人群的主要并发症。结果是肌肉浪费，这是发病率和死亡率增加的主要危险因素。在提出的研究建议中，我们假定补充β-羟基-Beta-reta-甲基丁酸（HMB），精氨酸和谷氨酰胺（HMB/ARG/GLN）以这些严重创伤的患者可以阻止肌肉组织和全身氮的丧失，从而降低了肌肉组织的丧失。该假设基于两项最近的研究，该研究表明与HMB/ARG/GLN相同的营养混合物可以逆转与艾滋病和癌症相关的肌肉浪费。在艾滋病和癌症中看到的多代谢状态具有类似的多层次病因，在创伤中也看到了。脂肪和肌肉动员，代谢率增加或正常的代谢率增加，蛋白质分解增加以及增加或正常的葡萄糖更新。此外，仅HMB已被证明可以减少氮的损失，减少肌肉蛋白水解和肌肉损伤，并在启动补充后的前48小时至三个星期内减少肌肉损伤。 男性和女性患者（n = 100）将在受到创伤ICU的招募时招募，ISS大于18患者的ISS将随机分配以接收1）标准管饲料加上标准管饲料以及单独使用的标准管饲料，单独使用HMB，或单独使用HMB，或单独使用HMB或标准的管饲料（对照）。临床结果措施将在医院住院期间进行评估，并在第4周和第12周的门诊病人进行。肌肉蛋白水解和氮经济将每天在医院和4周后在患者的基础上进行评估。 如果正如预期的话，I期结果证实了营养混合物在创伤患者中的有效性。 II阶段将提出扩展的多中心研究。