Cognitive function in dialysis patients: Ancillary study to the FHN trial

透析患者的认知功能：FHN 试验的辅助研究

• 批准号: 7264147
• 负责人: JOHN B STOKES
• 金额: $ 58.54万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-15 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7264147
• 关键词: Address; Agreement; Ancillary Study; Arts; Automobile Driving; Cognition; Cognitive; Control Groups; Daily; Defect; Dialysis patients; Dialysis procedure; Dose; End stage renal failure; Enrollment; Exhibits; Future; Goals; Health; Hemodialysis; Home environment; Impaired cognition; Kidney Failure; Life; Literature; Measurement; Measures; Motor; Nature; Neuropsychological Tests; Numbers; Outcome; Patients; Physical Dialysis; Pilot Projects; Psyche structure; Public Health; Randomized; Research; Research Personnel; Series; Short-Term Memory; Site; Speed; Standards of Weights and Measures; Technology; Test Result; Testing; Time; Today; Trail Making Test; United States National Institutes of Health; Upper arm; Week; cognitive function; design; impaired driving performance; improved; improved functioning; mortality; programs; skills; stem; trial comparing

DESCRIPTION (provided by applicant): The long term objective of this research is to improve the health of patients with End Stage Renal Disease who require hemodialysis. This proposed study is ancillary to the Frequent Hemodialysis Network (FHN) trial, a trial designed to determine if daily dialysis in a center, or nocturnal dialysis at home every night will substantially improve those factors that are responsible for the high mortality of dialysis patients. The proposed studies stem from two lines of reasoning. First, the FHN trial offers an unparalleled opportunity to determine if frequent dialysis will improve patients' cognitive function. The majority of the literature indicates that large numbers of dialysis patients have cognitive defects, but whether today's dialysis patients will improve their cognitive function with frequent dialysis is not so clear. We submit that the tests that will be used to measure cognitive function in the FHN trial as presently designed are not sensitive or specific enough to make clear conclusions. Second, the practical effects of improvements in cognitive function (as measured by modern tests) on real-life function is not clear. We propose to conduct a series of sensitive cognitive function tests on a subset of patients who will be enrolled in the FHN trial to determine if cognitive function is improved, and if so, which aspects are improved to the greatest extent. We will make these measurements on 260 patients located in 11 sites where patients will be randomized to conventional dialysis or to nocturnal dialysis, and another 5 sites where patients will be randomized to conventional dialysis or daily dialysis. In a second part of the study, we will begin an assessment of the relationship between cognitive impairment exhibited by dialysis patients and their ability to perform driving tasks in a driving simulator. With these measurements we will be able to determine which cognitive functions improve with frequent dialysis and which cognitive functions predict impaired driving skills in dialysis patients. The importance of these studies to the public health relates to improved health and function of patients who have kidney failure and who require dialysis. Knowing which impaired cognitive functions predict impaired driving skills will help develop strategies to improve cognition and thus enhance safe driving. Such strategies have the potential to make the highways safer for everyone.

描述（由申请人提供）：这项研究的长期目标是改善需要血液透析的终末期肾脏疾病患者的健康。这项拟议的研究是频繁的血液透析网络（FHN）试验的辅助，该试验旨在确定中心的每日透析是在中心的每日透析，还是每天晚上在家中的夜间透析将基本上改善透析患者死亡率高的因素。提出的研究源于两条推理。首先，FHN试验提供了无与伦比的机会来确定频繁的透析是否会改善患者的认知功能。大多数文献表明，大量透析患者具有认知缺陷，但是当今的透析患者是否会以频繁的透析改善其认知功能，尚不清楚。我们认为，由于目前设计的FHN试验中将用于测量认知功能的测试不足以明确结论。其次，尚不清楚认知功能改善（通过现代测试衡量）对现实生活功能的实际影响。我们建议对将入选FHN试验的一部分患者进行一系列灵敏的认知功能测试，以确定认知功能是否得到改善，如果是这样，则最大程度地改善了哪些方面。我们将对位于11个部位的260名患者进行这些测量，其中患者将被随机分为常规透析或夜间透析，另外5个部位将患者随机分为常规的透析或每日透析。在研究的第二部分中，我们将开始评估透析患者表现出的认知障碍与他们在驾驶模拟器中执行驾驶任务的能力之间的关系。通过这些测量值，我们将能够通过频繁的透析来确定哪些认知功能可以改善，哪些认知功能可以预测透析患者的驾驶技能受损。这些研究对公共卫生的重要性与肾衰竭和需要透析的患者的健康和功能的改善有关。知道哪种认知功能可以预测驾驶技能受损将有助于制定策略以改善认知，从而增强安全驾驶。这种策略有可能使所有人更安全。