Long-Term Risk of Kidney Stones in Living Kidney Donors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50,000
研究概览
简要总结
Using a population-based, matched, retrospective cohort approach, this study will evaluate the long-term risk of kidney stones among living kidney donors compared with matched healthy nondonors. Linked administrative health care databases from Ontario, Alberta, and British Columbia will be used and living kidney donors who donated between 1992 and 2024 will be identified and matched 1:10 to a carefully selected population of healthy nondonors based on baseline characteristics. The primary outcome is a surgical intervention for kidney stones (including shockwave lithotripsy, ureteroscopy or percutaneous nephrolithotomy). The secondary outcome is a hospital encounter with a kidney stone diagnosis.
详细描述
*Background*
The long-term risk of kidney stones following living kidney donation remains poorly understood. After donation, living donors have a solitary kidney, where kidney stones can cause more serious complications. These complications include ureteral obstruction and acute kidney injury, resulting in hospitalization and the need for surgical intervention to treat the kidney stone.
Previous studies have reported only a few stones at the time of nephrectomy for donors, and only one long-term study examined donation-attributable risks for kidney stones and kidney stone surgical intervention following donation, finding no increased risk. However, this study was limited by a small sample size and short follow-up (median 8.4 years).
In the general population, kidney stones affect 10-15% of individuals over a lifetime, and while most stones pass spontaneously, some require surgical intervention such as shockwave lithotripsy, ureteroscopy, or percutaneous nephrolithotomy. This study will evaluate whether living kidney donors, compared with healthy nondonors, have an increased risk of (i) kidney stones requiring surgical intervention and (ii) hospital encounters for kidney stones.
*Study Setting and Data Sources*
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria: Living kidney donors who underwent donor nephrectomy in Ontario, Alberta, and British Columbia, Canada, between July 1, 1992, and March 31, 2024 are eligible to enter the study.
排除标准
- •Any person with data errors in their database records (such as missing or invalid age; it is expected to exclude very few persons for these reasons). Data errors also include evidence of prior dialysis or a prior solid organ transplant, as such individuals are not eligible to become donors.
- •Any person who was not a permanent resident of the province (i.e., the patient lives outside of the province, and only came to the province to donate a kidney to the intended recipient). This will include anyone who is not eligible for the province's health insurance plan, anyone whose last contact date in the databases is less than 1 year after the cohort entry date, and anyone without a physician visit in the year following the nephrectomy hospital discharge.
- •Any person who is <18 years of age on the date of nephrectomy (as only under exceptional circumstances should a person less than 18 be approved for living donation).
- •Any person with a history of kidney stones.
- •*Non-donors*
- •Inclusion criteria: Before nephrectomy, living donors undergo rigorous health screening. A similarly healthy segment of the general population will be selected using restriction and matching. A random cohort entry date (simulated nephrectomy date) will be assigned to all persons who were residents of the province, according to the distribution of cohort entry dates among donors (July 1, 1992, to March 31, 2024).
- •Exclusion Criteria:
- •Any person with data errors in their database records (such as missing or invalid age).
- •Any person who was not a permanent resident of the province. This will include anyone who is not eligible for the province's health insurance plan and anyone whose last contact date in the databases is less than 1 year after the cohort entry date.
- •Any person who is <18 years of age on the cohort entry date.
- •Anyone who is pregnant at the time of the cohort entry date.
- •Baseline illnesses and measures of health care access from historic records preceding the cohort entry date will be identified. The sample of eligible nondonors will be restricted to persons without a recorded medical condition that could preclude donation. Such recorded medical conditions will include a hospitalization for mental illness in the prior year; an intensive care unit admission in the prior year; a hospitalization for palliative care services in the prior year; multiple hospital admissions in the prior year; high comorbidity (as assessed by the Charlson comorbidity index and adjusted clinical group scores, where data are available); receipt of home oxygen therapy; residence at a long-term care facility; dementia; any record of prior nephrology consultation or kidney disease (including receipt of dialysis, a kidney biopsy, or a kidney procedure such as a partial or complete nephrectomy); previous solid organ transplant; disorders of the kidneys, ureters, or bladder; any record of cardiovascular disease (congestive heart failure, cardiovascular procedures, myocardial infarction, peripheral vascular disease, abdominal aortic aneurysm repair, ischemic stroke); hypertension in individuals <50 years of age (persons with this condition are not accepted as donors in Canada); any record of obstructive sleep apnea; any cancer diagnosis; any liver disease or cirrhosis; diabetes; any serious infection (hepatitis, HIV, infective endocarditis); any record of autoimmune rheumatic conditions (such as rheumatoid arthritis or systemic lupus erythematosus); and any record of alcoholism.
- •To ensure the nondonors have access to health care services from physicians, nondonors who had no evidence of a family physician visit in the 2 years prior to cohort entry will be excluded. Additionally, nondonors with more than 5 family physician visits in the 2 years prior to cohort entry will be excluded, as this could suggest an active health issue that needs attention before donation could occur.
- •Any person with a history of kidney stones.
研究组 & 干预措施
Healthy non-donor cohort
A similarly healthy segment of the general provincial population was selected using restriction and matching to emulate the health criteria required for living kidney donation. A cohort entry date (simulated nephrectomy date) will be randomly assigned to all residents in the province, according to the distribution of cohort entry dates in the donor cohort (between July 1, 1992 and March 31, 2024).
Living kidney donor cohort
Living kidney donors who had a donor nephrectomy between July 1, 1992 and March 31, 2024, at transplant centres in the provinces of Ontario, Alberta, and British Columbia. Each nephrectomy date will serve as the cohort entry date.
干预措施: Living kidney donation (Procedure)