Outcomes in living kidney donors over 50 years compared to a healthy matched contemporaneous non-donor cohort from the same geographical region

50 年以上活体肾脏捐赠者的结果与来自同一地理区域的健康匹配的同期非捐赠者队列的比较

• 批准号: 10183243
• 负责人: ARTHUR J MATAS
• 金额: $ 63.19万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10183243
• 关键词: Affect; Age; Algorithms; Area; Birth; Blood Pressure; Body mass index; Cardiovascular Diseases; Cardiovascular system; Caring; Cessation of life; Characteristics; Chronic Kidney Failure; Clinic; Control Groups; County; Creatinine; Data; Data Collection; Data Set; Detection; Deterioration; Diabetes Mellitus; Disease; Documentation; Donor person; End stage renal failure; Epidemiology; Ethnic Origin; Event; Family history of; Focal Segmental Glomerulosclerosis; Future; Gender; General Population; Geographic Locations; Geography; Government Agencies; Health; Human; Hypertension; Incidence; Informed Consent; Kidney; Kidney Diseases; Kidney Failure; Kidney Transplantation; Link; Living Donors; Long-Term Effects; Longterm Follow-up; Maintenance; Medical History; Medical Record Linkage; Medical Records; Methods; Minnesota; Modeling; Nephrectomy; Onset of illness; Outcome; Outcome Study; Patients; Population; Population Control; Pre-Eclampsia; Pregnancy; Pregnancy Outcome; Proteinuria; Provider; Published Comment; Race; Rattus; Renal function; Reporting; Risk; Risk Factors; Selection Bias; Serum; Smoking; Smoking History; Statistical Data Interpretation; System; Time; Transplantation; United States Health Resources and Services Administration; United States National Institutes of Health; Universities; Work; adverse outcome; base; cardiovascular disorder risk; cohort; design; disorder risk; experience; follow-up; indexing; living kidney donor; mortality; operation; programs; prospective; research clinical testing; sex; surgical risk; tool

Abstract For an eligible patient with end stage kidney disease (ESRD), a living donor (LD) kidney transplant is the best option. But the LD has to have a major operation with surgical risks and the potential long-term risks of living with a single kidney. A number of studies comparing LDs with age, gender and race/ethnicity-matched general population controls have found no differences in long-term outcomes between the LDs and controls. However, recent studies comparing LDs to healthy matched controls have reported that the LDs are at increased risk for ESRD and death. There have been concerns about the matching of LDs and controls in these studies, including the matched controls were not contemporaneous [born in the same year]; were not from the same geographic area; were not known to be healthy on the date that matched the date of donation; and were not matched for family history of ESRD. Each of these factors can impact the risk of developing kidney disease and consequences of kidney disease. There have been concerns about the limited follow-up and the statistical analyses in these studies. In fact, some commentaries have suggested that the LD risk was under-estimated; others, overestimated. Having a complete and accurate understanding of true long-term LD risks is important to provide data to inform future LD candidates (informed consent), as well as to inform the design of long-term health maintenance/surveillance of donors. Government agencies, other stakeholders and LDs themselves are asking for better quality long-term data on LD outcomes. The University of Minnesota (U of Mn) and the Mayo Clinic have longstanding LD transplant programs (1st transplant in 1963) with data collection beginning at the time of the first transplant. In addition, the Rochester Epidemiology Project (REP) in the early 1960s established a linked medical records system that has followed the medical history of residents of Olmsted County and surrounding area (same geographic are as U of Mn and Mayo Clinic). Data from the REP has been used to provide long-term data on healthy populations, and methods are in place to identify healthy matched controls from the REP. We will match LDs with contemporaneous REP controls on age, gender, race/ethnicity and other important characteristics known to affect risk of kidney disease (e.g., BMI, smoking history, blood pressure). We will also match LDs and controls for being healthy (with normal renal function) on the date of donation and on family history of kidney disease. Because of the detailed, long-term (>50 year follow-up) quality data in the LD and REP datasets, we will be able to study and provide the best data to date on: LD risk of ESRD and death; LD risk of the much more common intermediate events that precede ESRD or death (e.g., deterioration of kidney function, cardiovascular disease); impact of known risk factors such as BMI or smoking on the risk of donation; the impact of new onset disease after donation (e.g., diabetes, hypertension) on LD outcomes; and the impact of donation on subsequent pregnancies. We will provide most comprehensive data, to date, to inform prospective LDs about long-term risk, and to inform the follow-up and care of current LDs.

摘要 对于符合条件的终末期肾病（ESRD）患者，活体供者（LD）肾移植是最佳选择 选项.但是，工人处必须进行大手术，而且有手术风险和潜在的长期生存风险 只有一个肾一些研究比较了LD与年龄、性别和种族/民族匹配的情况 一般人群对照组发现LD组和对照组之间的长期结局无差异。 然而，最近比较LD与健康匹配对照的研究报告称，LD为 终末期肾病和死亡的风险增加。在这些研究中，一直存在对LD和对照品匹配的担忧。 研究，包括匹配的对照不是同期的[出生在同一年];不是来自 相同的地理区域;在与献血日期匹配的日期不知道是否健康;并且 与终末期肾病家族史不匹配。这些因素中的每一个都可能影响患肾脏疾病的风险。 和肾脏疾病的后果。人们对有限的后续行动和统计数据感到关切。 这些研究中的分析。事实上，有些评论认为，LD风险被低估; 其他人，被高估了。对真正的长期LD风险有一个完整和准确的理解是很重要的 提供数据，以告知未来的LD候选人（知情同意），以及告知长期的设计 捐赠者的健康维护/监测。政府机构、其他利益攸关方和地方政府本身 要求更高质量的LD结局长期数据。明尼苏达大学（明尼苏达大学）和马约 诊所有长期的LD移植计划（1963年首次移植），数据收集始于 第一次移植的时间此外，罗切斯特流行病学项目（REP）在20世纪60年代初 建立了一个链接的医疗记录系统，跟踪奥姆斯特德居民的病史 县和周边地区（相同的地理是作为锰和马约诊所U）。来自REP的数据已被 用于提供关于健康人群的长期数据，并有方法确定健康匹配的 我们将在年龄、性别、种族/民族方面将LD与同期REP对照进行匹配 以及已知影响肾病风险的其它重要特征（例如，BMI、吸烟史、血液 压力）。我们还将在以下日期匹配LD和健康对照（肾功能正常） 捐赠和肾脏疾病家族史。由于详细、长期（>50年随访） LD和REP数据集中的高质量数据，我们将能够研究并提供迄今为止最好的数据：LD风险 ESRD和死亡的风险; ESRD或死亡之前更常见的中间事件的LD风险（例如， 肾功能恶化、心血管疾病）;已知风险因素（如BMI或吸烟）的影响 献血的风险;献血后新发疾病的影响（例如，糖尿病、高血压） 结果;以及捐赠对随后怀孕的影响。我们将提供最全面的数据， 到目前为止，告知潜在的LD长期风险，并告知当前LD的随访和护理。