Clinical Center - Outcomes of Live Organ Donors

描述（由申请人提供）：迄今为止，尚未有研究显示肾脏供体的长期风险增加。但人们认识到，已发表的研究存在供体随访不完整的问题，而且以前的供体已被列入移植名单。此外，最近的数据表明，轻度肾功能不全与心血管疾病的增加有关;因此，重要的是要了解这是否是单肾切除术的风险。我们广泛的长期目标是确定供体单肾切除术的长期风险，肾脏和肺捐赠的手术发病率（包括扩大标准的活体捐赠者），捐赠后的生活质量，以及捐赠者的知情同意程序是否充分。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供体单肾切除术的肾脏供体的生命状态; 2）确定供体单肾切除术的长期后果; 3）通过向DCC提供包含所有前明尼苏达大学肾脏和肺供体的数据集，为建立多中心活体供体数据库做出贡献，该数据集100%完整，准确，并且可以容易地与来自其他临床中心的供体数据库合并; 4）评估捐献后蛋白尿和肾功能降低是否（和，如果存在的话，贫血）与心血管风险增加和全因死亡率相关; 5）间隔5年对肾供体的肾功能、蛋白尿、HTN和贫血进行系列评估; 6）前瞻性研究所有肾脏和肺供体的围手术期、短期和中期并发症; 7）研究肾脏和肺供体的生活质量; 8）评估肾脏和肺供体的知情同意过程。这项研究的重要性在于，我们将能够提供最完整的长期供者随访。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。我们也将提供腹腔镜肾切除术和肺叶切除术后的短期和中期发病率和生活质量的重要信息。此外，这项研究将是第一项与活体捐赠有关的知情同意程序研究。获得的信息将是重要的，以解决，也许改变知情同意程序，为未来的活体捐赠者。

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.