Kidney transplantation postmortal kidney transplantation
Conditions
Interventions
The intervention for the donor kidney is 2 hours of normothermic, end-ischemic
machine perfusion.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Kidney related: In order to be eligible to participate in this study, the donor kidney must meet the following criteria: - Donation after Circulatory Death (DCD) type III/IV/V (Maastricht criteria) OR - Donation after Brain Death (DBD) donor kidney IF the kidney meets ECD criteria: o Donor >=60, OR o Donor 50-59 years with 2 of the following risk factors: history of high blood pressure, creatinine greater than or equal to 1.5 mg/dl (133 umol/l), death resulting from stroke. Recipient related: - Adult (>=18 years old) recipients. - Mentally competent recipients. - Recipients who receive renal replacement therapy at the moment of transplantation. - Recipients who provided written informed consent.
Exclusion criteria
Exclusion criteria: - Multi-organ transplant recipients (such as combined liver/kidney). - Receiving a donor kidney preserved on static cold storage. - Receiving a donor kidney that is explanted after normothermic regional perfusion. - DCD type I and II (Maastricht criteria). - Dual kidney transplantation - The patient receives another immunosuppression regime than standard-of-care (which is induction with basiliximab followed by triple therapy with tacrolimus, mycofenolate mofetil and prednisone)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of DGF/PNF. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical objectives: To evaluate the impact of NMP on the following graft outcomes: • The overall incidence of DGF. • The incidence of DGF, excluding dialysis sessions for hyperkalaemia or volume overload. • Duration of DGF, which is defined as the time between transplant and the last dialysis session. • Total number of post-transplant dialysis sessions (measured up to 3 months post-transplantation) • The incidence of PNF. • Estimated Glomerular Filtration Rate (eGFR) trajectory in the first year after transplant calculated with the Chronic Kidney Disease Epidemiology collaboration (CKD-EPI) formula. • eGFR at 1 year, 3 years and 5 years calculated with the CKD-EPI formula. • Biopsy-proven acute rejection within the first year post-transplant. • Graft survival up to 5 years. • Patient survival up to 5 years. • Length of hospital stay, calculated from transplantation date until the date of discharge. • The incidence and severity of (serious) adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) • Postoperative complications, graded according to the Clavien-Dindo classification Measures of microcirculation and pathophysiological processes: • To evaluate the association between microcirculation/oxyhaemoglobin concentration during NMP and immediate kidney function (no DGF/PNF). • To evaluate the association between microcirculation/oxyhaemoglobin concentration during NMP and other important graft outcomes: • DGF duration • Biopsy-proven acute rejection within the 1st year post-transplant • Estimated Glomerular Filtration Rate trajectory in the first year post-transplant • Graft survival up to 5 years • To investigate differences in gene expression profile of the donor kidney during the course of NMP (measured in biopsies taken during NMP hourly), and differences in gene expression profile in NMP compared to HMP. • To investigate the quantity of donor-derived cell-free DNA after tra | — |
Countries
Netherlands
Outcome results
None listed