ONSEPHF TRIAL--PILOT PHASE

高达65%的老年急性髋部骨折患者住院治疗 蛋白质-能量在入院时营养不足或发展严重 住院期间营养不良。这些营养不良的病人 出现严重院内并发症的风险增加， 发生并发症的可能性呈指数级增长 与营养不良的严重程度有关。尽管如此 事实是，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，只有极少数人得到了适当的治疗。 一些研究表明，积极的营养支持针对的是 这些营养不良的患者在以下两个方面可能是有益的 纠正营养不良，改善临床症状 结果。然而，这些发现尚未得到证实。小号的 关于所采用的方法的研究和问题 整形外科医生和其他健康提供者我们不相信 积极监测和治疗营养不良的好处 他们的老年髋部骨折患者。鉴于越来越多的 每年髋部骨折的老年患者，患病率 这一人群中的蛋白质-能量营养不良以及增加的风险 与营养不良相关的发病率，营养的疗效 需要建立改善结果的干预措施。 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，旨在测试攻击性药物的疗效 术后肠内营养支持降低术后并发症的发生率 术后并发症或改善长期预后 髋部骨折的老年患者的明确亚组 需要动手术。将采用的方法已经过测试，并 在最近完成的一项对16名患者的可行性研究中进行了细化。这个 这项第二阶段或试点研究的目标是建立 进行多中心营养统计分析的可行性 对这一患者群体的干预研究。具体地说，结果 将用于功率计算以估计样本大小 是主要研究所需要的。 在这项初步研究中，60名接受治疗的急性髋部骨折患者将 随机分为治疗组或对照组。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。被随机分配到对照组的患者将 接受标准护理，而治疗组将接受术后护理 在适当的医院以外的夜间肠道喂养手术 节食。在研究结束时，将对两组的营养进行比较 摄入量、营养状况的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.