活体肾供体安全性研究：一项前瞻性队列研究的方案
The Living Kidney Donor Safety Study: Protocol of a Prospective Cohort Study.
作者信息
Garg Amit X, Arnold Jennifer B, Cuerden Meaghan, Dipchand Christine, Feldman Liane S, Gill John S, Karpinski Martin, Klarenbach Scott, Knoll Greg A, Lok Charmaine, Miller Matthew, Monroy-Cuadros Mauricio, Nguan Christopher, Prasad G V Ramesh, Sontrop Jessica M, Storsley Leroy, Boudville Neil
机构信息
Victoria Hospital, London Health Sciences Centre, ON, Canada.
Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada.
出版信息
Can J Kidney Health Dis. 2022 Oct 28;9:20543581221129442. doi: 10.1177/20543581221129442. eCollection 2022.
BACKGROUND
Living kidney donation is considered generally safe in healthy individuals; however, there is a need to better understand the long-term effects of donation on blood pressure and kidney function.
OBJECTIVES
To determine the risk of hypertension in healthy, normotensive adults who donate a kidney compared with healthy, normotensive non-donors with similar indicators of baseline health. We will also compare the 2 groups on the rate of decline in kidney function, the risk of albuminuria, and changes in health-related quality of life.
DESIGN PARTICIPANTS AND SETTING
Prospective cohort study of 1042 living kidney donors recruited before surgery from 17 transplant centers (12 in Canada and 5 in Australia) between 2004 and 2014. Non-donor participants (n = 396) included relatives or friends of the donor, or donor candidates who were ineligible to donate due to blood group or cross-match incompatibility. Follow-up will continue until 2021, and the main analysis will be performed in 2022. The anticipated median (25th, 75th percentile, maximum) follow-up time after donation is 7 years (6, 8, 15).
MEASUREMENTS
Donors and non-donors completed the same schedule of measurements at baseline and follow-up (non-donors were assigned a simulated nephrectomy date). Annual measurements were obtained for blood pressure, estimated glomerular filtration rate (eGFR), albuminuria, patient-reported health-related quality of life, and general health.
OUTCOMES
Incident hypertension (a systolic/diastolic blood pressure ≥ 140/90 mm Hg or receipt of anti-hypertensive medication) will be adjudicated by a physician blinded to the participant's donation status. We will assess the rate of change in eGFR starting from 12 months after the nephrectomy date and the proportion who develop an albumin-to-creatinine ratio ≥3 mg/mmol (≥30 mg/g) in follow-up. Health-related quality of life will be assessed using the 36-item RAND health survey and the Beck Anxiety and Depression inventories.
LIMITATIONS
Donation-attributable hypertension may not manifest until decades after donation.
CONCLUSION
This prospective cohort study will estimate the attributable risk of hypertension and other health outcomes after living kidney donation.
背景
活体肾捐赠在健康个体中通常被认为是安全的；然而，有必要更好地了解捐赠对血压和肾功能的长期影响。
目的
确定与具有相似基线健康指标的健康、血压正常的非捐赠者相比，捐赠肾脏的健康、血压正常的成年人患高血压的风险。我们还将比较两组在肾功能下降率、蛋白尿风险以及健康相关生活质量变化方面的情况。
设计、参与者与研究地点：对2004年至2014年间从17个移植中心（加拿大12个，澳大利亚5个）术前招募的1042名活体肾捐赠者进行前瞻性队列研究。非捐赠者参与者（n = 396）包括捐赠者的亲属或朋友，或因血型或交叉配型不相容而无资格捐赠的捐赠候选者。随访将持续到2021年，主要分析将于2022年进行。捐赠后预期的中位（第25、75百分位数，最大值）随访时间为7年（6、8、15）。
测量
捐赠者和非捐赠者在基线和随访时完成相同的测量计划（非捐赠者被指定一个模拟肾切除术日期）。每年测量血压、估计肾小球滤过率（eGFR）、蛋白尿、患者报告的健康相关生活质量和总体健康状况。
结果
由对参与者捐赠状态不知情的医生判定是否发生高血压（收缩压/舒张压≥140/90 mmHg或接受抗高血压药物治疗）。我们将评估从肾切除术后12个月开始的eGFR变化率以及随访中出现白蛋白与肌酐比值≥3 mg/mmol（≥30 mg/g）的比例。使用36项兰德健康调查以及贝克焦虑和抑郁量表评估健康相关生活质量。
局限性
捐赠所致高血压可能在捐赠数十年后才会显现。
结论
这项前瞻性队列研究将估计活体肾捐赠后高血压及其他健康结局的归因风险。
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