Adjuvant Nutrition for Critically III Trauma Patients

描述（由申请人提供）：在每年需要住院治疗的400万例创伤病例中，20万例将被归类为严重创伤。在住院期间，营养不良是约50%患者的主要并发症。其结果是肌肉萎缩，这是发病率和死亡率增加的主要风险因素。在提出的研究建议中，我们假设向这些严重创伤患者补充β-羟基-β-甲基丁酸盐（HMB）、精氨酸和谷氨酰胺（HMB/Arg/Gln）可以阻止肌肉组织和全身氮的损失，从而降低发病率和死亡率。这一假设是基于最近的两项研究，表明HMB/Arg/Gln的相同营养混合物可以逆转与艾滋病和癌症相关的肌肉萎缩。艾滋病和癌症中的高代谢状态与创伤中的多因素病因相似。脂肪和肌肉的动员增加，代谢率增加或正常，蛋白质分解增加，葡萄糖周转增加或正常。此外，单独的HMB已被证明在开始补充后的前48小时至三周内减少氮损失，减少肌肉蛋白水解和肌肉损伤。 将在创伤ICU入院时招募ISS大于18的男性和女性患者（n=100）。符合入选/排除标准的患者将以盲法随机接受1）标准管饲加HMB/Arg/Gln、标准管饲加单独HMB或标准管饲（对照）。将在整个住院期间以及第4周和第12周的门诊患者中评估临床结局指标。在住院期间和4周后在门诊患者基础上每天评价肌肉蛋白水解和氮经济。 如果如预期的那样，第一阶段的结果证实了营养混合物在创伤患者中的有效性。II期将拟定扩展多中心研究。

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.