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临床试验/NCT00319579
NCT00319579已完成不适用

The Long Term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Prospective Pilot Study

Amit Garg15 个研究点 分布在 3 个国家目标入组 330 人开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Amit Garg
入组人数
330
试验地点
15
主要终点
Hypertension in living kidney donors

研究概览

简要总结

Kidney transplantation, a 'miracle' of modern medicine, is the preferred treatment option for End Stage Renal Disease compared to dialysis, patients who receive kidneys have a 70% reduction in risk of death, a dramatically improved quality of life and cost the health care system considerably less. As a result there are over 3000 Canadians, and 57,000 Americans on the waiting list for a kidney. To meet the shortage in cadaveric kidneys, rates of living kidney donation have nearly doubled over the last 10 years, and will continue to rise with growing demand.

Yet despite its advantages for the recipient, living kidney donation remains a complex ethical, moral and medical issue. The premise for accepting living donors is that the "minimal" risk of short and long-term medical harm realized by the donor is outweighed by the definite advantages to the recipient and potential psychosocial benefits of the altruistic gift to the donor. The only benefit for the living donor is psychological - donors experience increased self-esteem, feelings of well-being and improved health related quality of life with their altruistic act of assuming medical risk to help another. The short-term consequences of living donation are well established. On the other hand the long-term implications of living kidney donation are far less certain. This study will look at the long term implications of living kidney donation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than 18 years old
  • A predicted Cockcroft-Gault creatinine clearance > 80 mL/min
  • Average sBP < 140 and dBP < 90 based on 3 readings
  • A spot urine protein to creatinine ratio < 15 mg/mmol

排除标准

  • A medical condition (such as cardiovascular disease, pulmonary disease, active cancer) or psychological condition (such as major affective disorder, personality disorder, a history of chemical dependence) which the local transplant centre deems unfit for donation. Blood group and immunological incompatibility (such as positive cross-match, poor HLA matches) are not reasons for exclusion
  • Evidence of a financial incentive for donation
  • A contraindication to general anaesthesia or surgery
  • A past medical history of hypertension
  • Use of antihypertensive class medications for any reason.(ACE-Is, ARBs, diuretics, beta-blockers, calcium channel blockers)
  • A past history of permanent proteinuria
  • The eligible non-donor is planning to donate their kidney within the next year
  • Unable to give informed consent
  • Unwilling to participate in the follow-up assessments at one, two, three, four and five years, or unwilling or unable to conduct home blood pressure or laboratory measurements
  • The living donor or eligible non-donor is currently pregnant
  • Despite being planned the donor nephrectomy does not take place
  • Enrolled in another clinical study which interferes with the conduct or outcomes of this study

结局指标

主要结局

Hypertension in living kidney donors

时间窗: Annually for 5 years post donation

次要结局

未报告次要终点

研究者

发起方
Amit Garg
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amit Garg

MD, MA, FRCPC, FACP, PhD

Lawson Health Research Institute

研究点 (15)

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