Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors (IMPULSION)

• Evaluate improvement in the glomerular filtering rate [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: Yes ]
• Evaluate the recourse to dialysis [ Time Frame: 3 months following transplantation ] [ Designated as safety issue: Yes ]
• Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis) [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: Yes ]
• Evaluate patient survival [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: Yes ]
• 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. [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: Yes ]
• Identify perfusion profiles of the machine, which predict regaining renal function (absence of dialysis during the week after transplantation) and graft survival [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: Yes ]
• Evaluate the medico-economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: No ]

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

• Procedure: Static incubation

  Kidneys in this group are conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution before being transplanted.

  .

• Procedure: Pulsatile 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

• Static incubation
  If conservation in static incubation (group 1) is chosen by random selection, the transplant should be carried out while keeping the cold ischemic time (CIT) as short as possible (preferably less than 18 hours). Keep in mind that for reasons of homogeneity for result analysis and for conservation quality, it is recommended that kidneys in group 1 be conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution.
  Intervention: Procedure: Static incubation
• Experimental: Pulsatile perfusion
  If conservation in a pulsatile perfusion machine (group 2) is chosen by random selection, the kidney will be placed in the perfusion machine within two hours and should be kept there at least 6 hours and 8 hours if possible, before being transplanted
  Intervention: Procedure: Pulsatile perfusion

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