Development and Validation of a Predictive Energy Equation in Hemodialysis

血液透析中预测能量方程的开发和验证

• 批准号: 8732921
• 负责人: Laura Diane Byham-Gray
• 金额: $ 2.68万
• 依托单位: RBHS-SCHOOL/ HEALTH RELATED PROFESSIONS
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-25 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8732921
• 关键词: Acute; Adult; Affect; Applications Grants; Body Composition; Calories; Caring; Cessation of life; Chronic Disease; Chronic Kidney Failure; Clinical; Coupled; Cross-Sectional Studies; Demographic Factors; Desire for food; Development; Diagnosis; Dialysis patients; Dialysis procedure; Dietary Intervention; Dietary intake; Disease; Disease Progression; Energy Metabolism; Enrollment; Equation; Equipment; Ethnic Origin; Failure; Funding; General Population; Geographic Locations; Goals; Grant; Health; Health Services Research; Hemodialysis; Human; Indirect Calorimetry; Individual; Institution; Insurance; Intake; Intervention; Kidney Diseases; Laboratories; Life; Maintenance; Malignant neoplasm of lung; Malnutrition; Measures; Medicare; Medicine; Mentors; Metabolic; Methods; Morbidity - disease rate; Nutritional Support; Nutritional status; Oral; Outcome; Participant; Patients; Phase; Physiological; Population; Process; Protein-Energy Malnutrition; Publications; Publishing; Race; Renal Replacement Therapy; Renal function; Reporting; Research; Research Training; Rest; Risk; Risk Factors; Sampling; Site; Staging; Survival Rate; Technology; Testing; Time; Translating; United States; Validation; base; clinical practice; cost; design; experience; graduate student; improved; member; mortality; nutrient metabolism; nutrition; patient population; research study; undergraduate student; wasting

DESCRIPTION (provided by applicant): 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, 20% of all chronic kidney disease (CKD) patients receiving dialysis will die by years' end. This is an important problem, given the over half million individuals in US who are affected, the high cost in human suffering and loss, and the expense to Medicare and private insurance. Causes for this high mortality rate are multifactorial and interdependent, but protein-energy malnutrition is emerging as an independent risk factor in this population. The decline in kidney function leads to a spontaneous decline in appetite and oral intake, coupled with physiological alterations in nutrient and energy metabolism. Optimal nutritional care requires an appropriate predictive energy equation, based on an understanding of clinical factors, mechanisms, and 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, and generate a predictive energy equation specifically for use in patients with 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, we will compare the newly developed and validated predictive energy equation to several formulas often applied to this population. We will accomplish these aims using a 2-year, multi-site, Three prominent research and health care institutions within the Northeastern region of the United States will be included in the current study. Involving multiple sites assures appropriate demographic and clinical representation and content expertise in all aspects of the project. Each research site will plan to enroll approximately 75 participants of diverse races and ethnicities, representative of the geographic regions and the larger population of MHD patients (1). It is anticipated that enrollment will occur in a two-phase process: 1) Development Phase (i.e., development of the predictive energy equation and 2) Validation Phase (i.e., validation of the predictive energy equation). As per power estimations reported later in the grant proposal, it is anticipated that approximately 75 participants will be included in Phase 1: Development and the remaining 150 participants will be enrolled for Phase 2: Validation. Once enrolled, the participants will have their EE measured using a metabolic cart. The participants will also have their body composition measured as well as key laboratory parameters drawn (e.g., iPTH, CRP, A1C) in order to determine what, if any, factors impact EE.

描述（由申请人提供）：描述（由申请人提供）：尽管医学和技术取得了进步，但诊断为5期慢性肾脏疾病（CKD）的维持性血液透析（MHD）患者的临床结果仍然不理想。在美国，20%接受透析治疗的慢性肾脏疾病（CKD）患者会在数年后死亡。这是一个重要的问题，考虑到美国有50多万人受到影响，人类痛苦和损失的高昂成本，以及医疗保险和私人保险的费用。造成这种高死亡率的原因是多因素和相互依存的，但蛋白质能量营养不良正在成为这一人群中的一个独立风险因素。肾功能的下降导致食欲和口服摄入量的自发下降，并伴随着营养和能量代谢的生理改变。最佳营养护理需要一个适当的预测能量方程，基于对临床因素、机制的理解，以及能量消耗（EE）的准确测定。目前还没有这样的理解或方程式存在于这一患者群体。因此，本研究旨在描述相关参数，有助于理解这一重要的临床状况，并生成专门用于CKD患者的预测能量方程，从而改善临床实践，降低患者发病率和死亡率。我们提出的研究目标是：1)确定哪些临床因素可以预测诊断为MHD的5期CKD患者的情感表达；2)开发并验证一个预测能量方程，该方程包含了所有影响MHD的5期CKD患者的临床因素；3)为了进一步测试临床效用，我们将比较新开发和验证的预测能量方程与通常应用于该人群的几个公式。我们将通过一个为期2年、多地点的研究来实现这些目标。目前的研究将包括美国东北部地区三家著名的研究和卫生保健机构。涉及多个站点确保在项目的各个方面都有适当的人口统计学和临床代表性和内容专业知识。每个研究地点将计划招募大约75名不同种族和民族的参与者，代表地理区域和更大的MHD患者群体(1)。预计入组将分为两个阶段：1)开发阶段（即预测能量方程的开发）和2)验证阶段（即预测能量方程的验证）。根据拨款提案中稍后报告的功率估计，预计约有75名参与者将被纳入第一阶段：开发，其余150名参与者将被纳入第二阶段：验证。一旦登记，参与者将使用代谢车测量他们的情感表达。参与者还将测量他们的身体成分以及绘制关键的实验室参数（例如，iPTH， CRP, A1C），以确定影响EE的因素（如果有的话）。