Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors

Study Overview
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Brief Summary
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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

Official Title
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Interest of Pulsatile Perfusion Preservation on Outcomes in Kidney Transplantation From Expanded Criteria Donors

Conditions
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Chronic Renal Failure

Intervention / Treatment
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* Procedure: Static incubation
* Procedure: Pulsatile perfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Static incubation<br>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. | Procedure: Static incubation<br>* Kidneys in this group are conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution before being transplanted. .<br>|
| Experimental: Pulsatile perfusion<br>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 | Procedure: Pulsatile perfusion<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate improvement in the glomerular filtering rate |  | 12 months after transplantation | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplantation, Chronic renal failure, Marginal kidney graft, Pulsatile perfusion machine