ONSEPHF TRIAL--PILOT PHASE

高达65%的急性髋部骨折住院老年患者 入院时蛋白质能量营养不足或发生严重 住院期间营养不良。这些营养不良的病人 患严重住院并发症的风险增加， 出现并发症的可能性呈指数级增加， 与营养缺乏的严重程度有关。尽管有这些 事实上，老年髋部骨折患者很少接受完整的 营养评估。因此，他们的营养不足是 通常得不到承认，很少得到适当的治疗。 几项研究表明，积极的营养支持，针对 这些营养不良的患者可能在以下两方面都是有益的： 纠正他们的营养不足，改善他们的临床 结果。然而，这些发现尚未得到证实。小尺寸 关于所采用的方法的研究和问题已经离开 整形外科医生和其他健康服务提供者不相信 积极监测和治疗营养不足的好处 老年髋部骨折患者的情况。鉴于越来越多的 每年髋部骨折的老年患者中， 这一人群的蛋白质-能量营养不良， 与营养不良有关的发病率，营养的功效 需要采取干预措施以改善结果。 该提案是作为第二阶段（或试点研究）提交的， 一系列计划中的研究，旨在测试积极的 术后肠内营养支持，以降低术后并发症的发生率， 术后并发症或改善长期结果， 定义的髋部骨折老年患者亚组 需要手术所采用的方法已经过测试， 在最近完成的对16名患者的可行性研究中进行了改进。的 第二阶段或试点研究的目标是建立 进行统计学上强大的多中心营养的可行性 在这一患者群体中进行干预研究。具体来说，结果 将用于功效计算，以估计样本量 主要研究所需。 在试点研究中，60名患有急性髋部骨折的患者将 随机分配至治疗组或对照组。所有研究 受试者将接受重复的临床和营养评估， 他们的住院治疗。随机分配至对照组的患者将 接受标准护理，而治疗组将接受术后护理， 除了适当的医院外， 饮食.在研究结束时，将比较各组的营养素 摄入量、营养状况变化以及短期和长期 临床结果。

Up to 65% of elderly patients hospitalized with an acute hip fracture are protein-energy under nourished at admission or develop serious nutritional deficits while hospitalized. These undernourished patients are at increased risk of developing serious in-hospital complications, the likelihood of developing a complication increasing exponentially in relation to the severity of the nutritional deficits. Despite these facts, elderly hip fracture patients rarely receive a complete nutritional assessment. Consequently, their nutritional deficits are usually not recognized and only rarely is adequate treatment provided. Several studies suggest that aggressive nutritional support targeted to these undernourished patients may be beneficial both in terms of rectifying their nutritional deficits and improving their clinical outcomes. However, these findings have not been confirmed. The small size of the studies and questions about the methodology employed have left orthopedic surgeons and other health we providers unconvinced as to the benefits of aggressively monitoring and treating the nutritional deficits of their elderly hip fracture patients. Given the increasing number of elderly patients who fracture their hip each year, the prevalence of protein-energy undernutrition in this population, and the increased risk of morbidity associated with poor nutrition, the efficacy of nutrition intervention to improve outcomes needs to be established. This proposal is being submitted as the second (or pilot study) phase of a planned series of studies designed to test the efficacy of aggressive post-operative enteral nutrition support to decrease the rate of postoperative complications or improve longterm outcomes in specifically defined subgroups of elderly patients who have sustained a hip fracture requiring surgery. The methods to be employed have been tested and refined in a recently completed feasibility study of 16 patients. The objective of this second phase or pilot study is to establish the feasibility of conducting a statistically powerful multi-center nutrition intervention study in this patient population. Specifically, the results will be utilized for power calculations to estimate the sample size needed for the main study. In the pilot study, 60 patients admitted with an acute hip fracture will be randomized to either a treatment or a control group. All study subjects will undergo repeat clinical and nutritional assessments during their hospitalization. Patients randomized to the control group will receive standard care while the treatment group will receive post- operative nightly enteral feedings in addition to an appropriate hospital diet. At study end, the groups will be compared with respect to nutrient intake, change in nutritional status and both short and long-term clinical outcomes.