Investigation of the physical and psychosocial outcomes after living kidney donation - a multicenter cohort study (SoLKiD - Safety of Living Kidney Donors)

Abstract

BackgroundOver the last years, living kidney donation (LKD) has been established for patients with endstage renal failure as an alternative to post mortem donation, which is limited by organ scarcity and long lasting waiting periods. From an ethical perspective, the increase in LKD requires that donors’ physical, psychological, and social harm has to be minimized as much as possible and the risk should not exceed the generally expected consequences of nephrectomy. Despite of numerous, mainly retrospective studies about the postoperative outcome of LKD over the last years from different countries, it becomes apparent that there is a lack of comprehensive prospective multicenter research in this field worldwide. Therefore, the main aim of the study is to examine the physical and psychosocial outcome of living kidney donors in a prospective design before and after transplantation in an interdisciplinary approach (surgery, nephrology, psychosocial medicine).Methods/designThe goal of the study is to investigate such aspects as the impact of gender- and age-specific factors on LKD outcome, donor outcome in correlation to the health status of the recipient, the medical and psychosocial risk of a healthy subject undergoing the LKD procedure. The study is carried out as a nationwide multicenter study. All adult living kidney donors with sufficient knowledge in the German, Russian, or Turkish language, informed consent, and place of residence in Germany are included. In a naturalistic design (cohort study), clinical data and self-report measures (questionnaires) of 320 donors are collected before and 8 weeks, 6 and 12 months after donation. Primary outcome parameters are the kidney function (estimated GFR) and the quality of life (SF-36) of the donor. Secondary outcome parameters are data about physical (e.g., wound healing, blood pressure) and psychosocial (fatigue, depression, anxiety, somatization) outcome after donation.DiscussionPrevious studies on the postoperative outcome of living kidney donors have methodological limitations and/or were carried out in countries with different healthcare systems, e.g. United States, Norway, Canada, United Kingdom. Thus, results cannot be generalized and are not particularly applicable to the risks of mainly caucasian living kidney donors in the German healthcare system. The study design overcomes these disadvantages in that it provides a prospective multicenter design.Trial registrationGerman Clinical Trials Register DRKS00006552 (22 September 2014).

Prognostic Value of Growth Differentiation Factor 15 in Kidney Donors and Recipients

“…Interestingly, the correlation between GDF15 and eGFR in the group of LD was not preserved in opposite to recipients, hinting towards a different mechanism of GDF15 activation in LD. This is an arousing aspect since it was shown that patients with chronic fatigue syndrome, which has been linked to LD, display higher GDF15 levels than healthy controls [30,31]. Interestingly, healthy controls had GDF15 values comparable to LD values before surgery, while patients with fatigue had comparable values to LD one year after KD.…”

Live kidney donor: surgical aspect and outcome

“…This is consonant with the quality of life described after donation in the long-term follow-up of living kidney donors. 43 While some studies found that the rate of hypertension after unilateral nephrectomy to be as high as 25-74.5%, others failed to show any increase in BP after surgery. The frequency of hypertension in the present donor population was lower than that in the healthy adult population of Egypt (22% versus 26%); this is not unexpected, because the donors were positively selected for a normal BP.…”

Die Sicherheit des Lebendnierenspenders – Das Deutsche Lebendspende Register SOLKID-GNR – Entstehung und Struktur eines nationalen Registers in der Versorgungsforschung

“…Das Deutsche Lebendspende Register SOLKID-GNR (Safety of the Living Kidney Donor -The German National Register) wurde als Nachfolgeprojekt der in Münster initiierten SoLKiD Studie [13] als interdisziplinäres Register von drei Transplantationszentren (Münster, Heidelberg, Hamburg, jetzt Mainz) im Rahmen des BMBF (Bun-desministerium für Bildung und Forschung) Calls "Modellhafte Register -Konzeptentwicklungsphase" (Förderkennzeichen: 01GY1725) beantragt. Das BMBF fördert seit dem 1.…”