Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient

Study Overview
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Brief Summary
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Comparison of two techniques of renal pre-transplant infusion on the evolution of renal function in the recipient: multicentre randomized trial

Detailed Description
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Both machines differ in their operation: the LifePort® machine manufactured by the Organ Recovery System (ORS), says renal perfusion by maintaining a continuous perfusion pressure that is adjustable, while the Waves machine company Medical Waters assures infusion maintaining a controlled pulsatile flow. Both machines are now available but the investigators currently have no study of whether an infusion type is superior to the other in terms of results on renal function recipients. Study the impact of both types of infusion on renal function recipients evaluated in the early days of transplantation, at three months and one year after the transplant.

Official Title
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Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient: Multicentre Randomized Trial

Conditions
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Transplantation, Kidney

Intervention / Treatment
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* Device: LifePort® perfusion device
* Device: Waves perfusion device


Participation Criteria
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Eligibility Criteria
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RENAL Donors: Inclusion Criteria: Deceased donor in brain-dead Donor presenting the expanded criteria of kidney removal (ECD criteria: elderly over 60 or aged 50 to 59 years and has two of the three following criteria: hypertension, stroke deaths, serum creatinine> 1.5 mg / dL) Possibility of both kidneys perfused machines Sampling of both kidneys, for two distinct recipients Exclusion Criteria: none RENAL recipients: The grafts are addressed to transplant centers in France according to the distribution rules of the National Center of Distribution of transplants . (Pôle National de Répartition des Greffons (PNRG).

Ages Eligible for Study
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Minimum Age: 50 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney : perfusion device lifeport<br>Each donor (n=140) will provide one kidney for pulsatile perfusion. | Device: LifePort® perfusion device<br>* Renal Perfusion with LifePort® perfusion device<br>* Other names: A;|
| Kidney : perfusion device waves<br>Each donor (n=140) will provide one kidney for continuous perfusion. | Device: Waves perfusion device<br>* Renal Perfusion with Waves perfusion device<br>* Other names: B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular Filtration Rate | Rate of patients with a Glomerular Filtration Rate (GFR) calculated by the MDRD ≥ 45 ml / min / 1,73m² (considered normal in a renal graft) at 3 months post-transplantation (MDRD: Modification of Diet in Renal the Disease) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine <250 mg / dL | Time for obtaining a serum creatinine <250 mg / dL and need for dialysis in recovery during the first seven days post transplant. | 1 week | 
| RFG | Absence of a recovery renal function at 1 month. | 1 month | 
| MDRD | Modification of Diet in Renal the Disease at 1 year | 1 year | 
| GSR | graft survival rate at 1 year. | 1 year | 
| Renal Biopsie results | Results of analyzes of kidney biopsies punctures to 3 months. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal infusion, Renal infusion device