ONSEPHF TRIAL--PILOT PHASE

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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.