Development and Validation of a Predictive Energy Equation in Hemodialysis

描述(由申请人提供)：尽管医学和技术取得了进步，但在接受维持性血液透析(MHD)的5期慢性肾脏病(CKD)患者中，临床结果仍然不佳。在美国，每两名接受维持性透析的患者中就有一人会在启动肾脏替代疗法后的三年内死亡。这是一个重要的问题，因为美国有50多万人受到影响，人类痛苦和损失的成本很高，医疗保险和私人保险的费用也很高。造成这一人群高死亡率的原因是多因素的、相互依存的。蛋白质-能量营养不良或消瘦已成为该人群死亡的一个独立风险因素。肾功能的下降会导致 食欲和口服摄入量的自发减少，加上营养和能量代谢的生理性变化。为了抵消疾病过程的后遗症，必须优化营养护理。有效的营养干预需要一个适当的预测能量方程，基于对临床因素、机制的了解，并准确地确定能量消耗(EE)。目前，对于这一患者群体还没有这样的理解或方程式。因此，这项拟议的研究旨在描述相关参数，有助于了解这一重要的临床状况，并生成一个专门用于晚期CKD患者的预测能量方程，从而改善临床实践，降低患者的发病率和死亡率。我们建议的研究的目标是：1)确定哪些临床因素可以预测MHD的5期CKD患者的EE；2)开发和验证一个预测能量方程，该方程包含了在MHD的5期CKD患者中测量的所有影响临床因素；以及3)进一步测试该方程的临床实用性和应用。我们将使用2 年，多点，横断面研究，采用分裂样本设计，为本科生和研究生提供大量参与研究过程的机会。拟议的研究将使用多个站点，以确保在项目的所有方面都有适当的人口和临床表现和内容专业知识。与我们的力量估计一致，每个研究站点计划招募75名来自不同种族和民族的参与者，他们代表了地理区域和更大的MHD患者群体。预计注册将分两个阶段进行：1)开发预测能量方程(阶段1)和2)验证方程(阶段2)。一旦登记，参与者将测量他们的静息EE和身体成分，并收集关键的实验室参数(例如iPTH、CRP、A1C)，以确定如果有影响EE的因素。 与公共卫生相关：透析中被诊断为肾病的患者结果不佳的部分原因是这些人经常经历的营养不良状况。只有当医生有适当的方法准确地评估代谢率时，才能为透析患者提供高质量的营养护理。这项拟议的研究将计划开发一种公式，准确地确定透析患者所需的卡路里数量，以阻止健康状况的进一步损害。

DESCRIPTION (provided by applicant): Despite advances in medicine and technology, clinical outcomes among patients diagnosed with stage 5 chronic kidney disease (CKD) on maintenance hemodialysis (MHD) have remained suboptimal. In the United States, one out of two patients receiving maintenance dialysis will die within three years of initiating renal replacement therapy. This is an important problem, given the over one-half million individuals in the US who are affected, the high cost in human suffering and loss, and the expense to Medicare and private insurance. Causes for this population's high mortality rate are multifactorial and interdependent. Protein-energy malnutrition or wasting has emerged as an independent risk factor for mortality in this population. The decline in kidney function leads to a spontaneous reduction in appetite and oral intake, coupled with physiological alterations in nutrient and energy metabolism. To offset the consequent sequelae of the disease process, nutritional care must be optimized. Effective nutritional intervention requires an appropriate predictive energy equation, based on an understanding of clinical factors, mechanisms, and an accurate determination of energy expenditure (EE). Currently no such understanding or equation exists for this patient population. Therefore, this proposed study seeks to characterize the relevant parameters, contribute to the understanding of this significant clinical condition, an generate a predictive energy equation specifically for use in patients with advanced CKD, thereby improving clinical practice and reducing patient morbidity and mortality. The goals of our proposed study are 1) to determine what clinical factors predict EE in patients diagnosed with stage 5 CKD on MHD; 2) to develop and validate a predictive energy equation that incorporates all of the influencing clinical factors measured in stage 5 CKD patients on MHD; and 3) to further test the clinical utility and application of this equation. We will accomplish these aims using a 2 year, multi-site, cross-sectional study with a split-sample design that affords numerous opportunities for undergraduate and graduate students to participate in the research process. The proposed study will use multiple sites to assure appropriate demographic and clinical representation and content expertise in all aspects of the project. Consistent with our power estimations, each research site plans to enroll 75 participants of diverse races and ethnicities, representative of the geographic regions and the larger population of MHD patients. It is anticipated that enrollment will occur in a two-phase process: 1) development of the predictive energy equation (Phase 1) and 2) validation of the equation (Phase 2). Once enrolled, the participants will have their resting EE and body composition measured as well as key laboratory parameters collected (e.g., iPTH, CRP, A1C) in order to determine what, if any, factors impact EE. PUBLIC HEALTH RELEVANCE: Partly responsible for the poor outcomes in patients diagnosed with kidney disease on dialysis is the malnourished condition often experienced by these individuals. Quality nutrition care for dialysis patients can only be provided when practitioners have appropriate methods to evaluate the metabolic rate accurately. This proposed study will plan to develop a formula that will precisely determine the number of calories a dialysis patient requires in order to thwart further compromise in health condition.