The investigators would like to introduce and clinically evaluate prolonged normothermic machine perfusion (PNMP) to preserve and assess high-risk donor kidneys prior to transplantation.
Currently kidney transplantation is the only viable option for patients with kidney failure to regain quality of life and health. The number of organs available for transplantation is insufficient with a widening gap between supply and demand. Nowadays, centers accept older and higher risk donor organs with co-morbidity, often leading to non-function, complications and with half of the patients back on dialysis within 15 years. Furthermore, many donor kidneys have to be discarded as too damaged and beyond repair. Increasing the quality and therefore transplantability of these high-risk donor organs could significantly increase the donor kidney pool. Using prolonged normothermic perfusion of marginal donor organs, the investigators aim to kick start regeneration in the kidney before transplantation, improving function and survival long-term. Furthermore, the choice to accept or decline a donor kidney organ is currently based on subjective criteria and causes great uncertainty amongst clinicians. There is a dire need for tools to aid in decision making and reduce this uncertainty. Biomarkers predictive of graft regeneration are lacking. Samples from perfused kidneys and donor recipients will be collected and analysed to allow the formulation of a kidney fitness index.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
First, a cohort of DCD kidneys (n=6) will be subjected to 1 hour of NMP and subsequently transplanted \[NMP1\]. Before extending the duration, secondary endpoints will be evaluated. Thereafter, the duration of NMP will be prolonged to 3 hours (n=6) \[PNMP3\] and consequently 6 hours (n=6) \[PNMP6\].
University Medical Center Groningen
Groningen, Netherlands
RECRUITINGLeiden University Medical Center
Leiden, Netherlands
RECRUITINGglomerular filtration rate (GFR)
renal function defined by the estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Time frame: 6 months post transplantation
glomerular filtration rate (GFR)
renal function defined by the estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Time frame: 1 month post transplantation
glomerular filtration rate (GFR)
renal function defined by the estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Time frame: 3 months post transplantation
primary non-function
defined as permanent lack of graft function from the time of transplantation, was diagnosed when a kidney graft was well perfused (confirmed by ultrasound examination) but never functioned, necessitating dialysis after kidney transplantation
Time frame: 6 months post transplantation
delayed graft function (DGF)
defined as the need for postoperative dialysis during the first 7 days after transplantation
Time frame: 6 months post transplantation
patient and graft survival
time from transplant to patient death, and graft failure
Time frame: 6 months post transplantation
adverse events
defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the normothermic machine perfusion of the donor kidney prior to transplantation
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Time frame: 6 months post transplantation
postoperative complications
graded according to the comprehensive complication index
Time frame: 6 months post transplantation