Chronic Renal Failure
Conditions
Keywords
Chronic renal failure, Transplantation, Marginal kidney graft, Pulsatile perfusion machine
Brief summary
Our hypothesis is that the Waters Medical® pulsatile perfusion machine (RM 3) is a way to improve delayed graft function (DGF) in marginal grafts, and some perfusion profiles (flow, pressure, resistance index, venous effluent pH) are correlated with better recovery of renal function (without dialysis during the first week after transplant). Observation or Investigation Method Used : The study is multicenter, prospective, open, controlled and randomized:grafts are divided into two parallel groups: * group 1 corresponds to a conservation of grafts in static incubation * group 2 corresponds to conservation using a pulsatile perfusion machine Duration and Organizational Arrangements for Research : The total duration of the study is planned for 36 months. This duration includes: * an inclusion period that will last 24 months, * the follow-up of recipient patients from the day of transplantation until twelve months after the operation
Interventions
PROCEDUREStatic incubation
Kidneys in this group are conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution before being transplanted. .
PROCEDUREPulsatile perfusion
Kidneys in this group are placed in the pulsatile perfusion machine(RM 3) within two hours and should be kept there at least 6 hours and 8 hours if possible, before being transplanted
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
for marginal graft: * donors over 60 years of age * donors between 50 and 60 years of age with at least one of the following characteristics : * history of diabetes mellitus * history of high blood pressure * serum creatinine \>1,5 mg/dL * death by stroke (haemorrhagic or thrombotic) Inclusion criteria for recipient : * patients registered on the kidney transplant waiting list likely to receive a marginal kidney * immunized patients whose anti-HLA antibody specificities have been determined
Exclusion criteria
for recipient: * pregnant or breastfeeding women * people who have been incarcerated * minors * adults under guardianship * people who are not affiliated with the French healthcare system * people with HLA immunization whose HLA antibody specificities have not been determined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delayed graft function (DGF) rate defined as the need to resort to dialysis during the first week after transplantation. The main dialysis factors retained are hydrosodic and/or hyperkalemic overload. | First week after transplantation |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the recourse to dialysis | 3 months following transplantation |
| Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis) | 12 months after transplantation |
| Evaluate patient survival | 12 months after transplantation |
| Evaluate improvement in the glomerular filtering rate | 12 months after transplantation |
| Identify perfusion profiles of the machine, which predict regaining renal function (absence of dialysis during the week after transplantation) and graft survival | 12 months after transplantation |
| Evaluate the medico-economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts | 12 months after transplantation |
| Stratify the analysis of regaining function and graft survival using Nyberg's classification in order to determine which risk groups would most benefit from pulsatile perfusion. | 12 months after transplantation |
Countries
France
Outcome results
None listed