chronic kidney failure renal failure
Conditions
Interventions
At the Erasmus MC operating room complex, the donor kidney(s) will be unpacked
under sterile conditions, benched to assess acceptability for transplantation.
During the benching, 2 pre-defined biops
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Recipient age * 65 yr - Listed for renal transplantation due to end stage renal disease on the ET list
Exclusion criteria
Exclusion criteria: - Donor kidney which is unsuitable for transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the logistic challenges in including patients and treatment with normothermic ex vivo kidney perfusion (e.g. failed perfusion procedures, renal artery or vein thrombosis, participation rate). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Renal histology at start and end of normothermic perfusion 2. Measured glomerular filtration rate * the best surrogate of graft function * (first 4 weeks, 3-months post-transplant), which is considered to be a predictor of long term kidney graft survival as well. 3. 3-month graft (censored and uncensored for recipient death) and patient survival 4. Incidence and severity of delayed graft function defined as the need for dialysis within the first 7 days after kidney transplantation and preceding the return of kidney function. * 5. Incidence of primary non-function (PNF) defined as the permanent lack of function of the graft from time of transplantation until months post-transplant. This endpoint is determined post-hoc at 3 months post-transplant. * 6. Biopsy proven acute rejection within 3 months post-transplant. | — |
Countries
Netherlands
Outcome results
None listed