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

描述(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病患者的健康。这项拟议的研究是对频繁血液透析网络(FHN)试验的辅助，该试验旨在确定每天在中心进行透析或每晚在家进行夜间透析是否会显著改善导致透析患者高死亡率的那些因素。拟议的研究源于两条推理路线。首先，FHN试验提供了一个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，大量的透析患者存在认知缺陷，但现在的透析患者通过频繁的透析是否会改善他们的认知功能还不是很清楚。我们认为，按照目前的设计，在FHN试验中用于测量认知功能的测试不够敏感或足够具体，不足以得出明确的结论。其次，认知功能的改善(通过现代测试来衡量)对现实生活功能的实际影响尚不清楚。我们建议对将参加FHN试验的部分患者进行一系列敏感的认知功能测试，以确定认知功能是否得到改善，如果是，哪些方面得到了最大程度的改善。我们将对分布在11个地点的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个地点将患者随机分为常规透析或日常透析。在研究的第二部分，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，我们将能够确定哪些认知功能在频繁透析时得到改善，哪些认知功能预测透析患者的驾驶技能受损。这些研究对公众健康的重要性与改善肾衰竭患者和需要透析的患者的健康和功能有关。了解哪些认知功能受损预示着驾驶技能受损，将有助于制定改善认知的策略，从而提高安全驾驶。这样的策略有可能让高速公路对每个人来说都更安全。

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.