Clinical Center - Outcomes of Live Organ Donors

描述(由申请人提供)：到目前为止，还没有一项研究表明肾脏捐赠者的长期风险增加。但人们认识到，已发表的研究缺乏对捐赠者的跟踪，而且以前的捐赠者已被列入移植名单。此外，最近的数据表明，轻度肾功能障碍与心血管疾病的增加有关；因此，了解这是否为单肾切除的风险是很重要的。我们广泛的长期目标是确定捐赠者单肾切除的长期风险、肾和肺捐赠的手术发病率(包括扩大标准的在世捐赠者)、捐赠后的生活质量，以及捐赠者的知情同意程序是否足够。我们的具体目标是：1)定位并确定所有在明尼苏达大学接受过供者单肾切除的肾脏捐赠者的生命状态；2)确定捐赠者单肾切除的长期后果；3)通过向DCC提供包含所有前明尼苏达大学肾和肺捐赠者的数据集，100%完整、准确，并且可以很容易地与其他临床中心的捐赠者数据库合并，为建立多中心活体捐赠者数据库做出贡献；4)评估捐献后蛋白尿和肾功能降低(如果存在的话，贫血)是否与心血管风险增加和所有原因死亡相关；5)每隔5年对肾捐赠者的肾功能、蛋白尿、HTN和贫血进行一系列评估；6)前瞻性研究所有肾和肺捐赠者的围手术期、短期和中期并发症；7)研究肾和肺捐赠者的生活质量；8)评估肾和肺捐赠者的知情同意程序。这项研究的重要性在于，我们将能够提供现有的最完整的长期捐助者后续行动。这些信息将提供给未来的潜在捐助者，以便他们能够做出知情的决定。我们还将提供有关腹腔镜肾切除术和肺叶切除术后短期和中期发病率以及生活质量的重要信息。此外，这项研究将是关于知情同意程序与活体捐赠相关的第一次研究。所获得的信息对于解决甚至可能改变未来在世捐赠者的知情同意程序将是重要的。

DESCRIPTION (provided by applicant): To date, there has not been a study showing increased long-term risk to kidney donors. But it is recognized that published studies suffer from incomplete donor follow-up, and that former donors have been listed for transplantation. In addition, recent data suggests that mild renal dysfunction is associated with increased cardiovascular disease; therefore it is important to learn if this is a risk of uninephrectomy. Our broad long-term objectives are to determine the long-term risks of donor uninephrectomy, the operative morbidity of kidney and lung donation (including for the expanded criteria living donor), the quality of life after donation, and whether the informed consent process for donors is adequate. Our specific aims are: 1) To locate, and ascertain the vital status for all kidney donors having had donor uninephrectomy at the University of Minnesota; 2) To determine the long term consequences of donor uninephrectomy; 3) To contribute to the establishment of a multicenter living donor database by providing the DCC with a data set that contains all former University of Minnesota kidney and lung donors and is 100% complete, accurate, and can be easily merged with donor databases from the other clinical centers; 4) To evaluate whether post donation proteinuria and reduced kidney function (and, if present, anemia) are associated with an augmented cardiovascular risk and all cause mortality; 5) To perform serial assessments, 5 years apart, of kidney function, proteinuria, HTN, and anemia in kidney donors; 6) To prospectively study perioperative, short and medium-term complications on all kidney and lung donors; 7) To study quality of life in kidney and lung donors; and, 8) To evaluate the informed consent process for kidney and lung donors. The importance of this study is that we will be able to provide the most complete long-term donor follow-up available. This information will be available for future prospective donors so that they can make an informed decision. We will also provide important information on short and medium-term morbidity, and quality of life after laparoscopic nephrectomy and lung lobectomy. In addition, this study will be the first study of the informed consent process in relation to living donation. Information gained will be important to address and perhaps change the informed consent process for future living donors.