Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors

Hospices Civils de Lyon162 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

162

Conditions

Chronic Renal Failure

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: First week after transplantation