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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney : perfusion device lifeport | Each donor (n=140) will provide one kidney for pulsatile perfusion. |
| |
| Kidney : perfusion device waves | Each donor (n=140) will provide one kidney for continuous perfusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LifePort® perfusion device | Device | Renal Perfusion with LifePort® perfusion device |
|
| 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 |
| 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. |
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RENAL Donors:
Inclusion Criteria:
Exclusion Criteria:
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).
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RENAL Donors and recipients
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Christophe VENHARD, MD-PhD | University Hospital, Tours | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coordination Hospitalière de PMO , Pôle USSAR-Anestéthésie -Réa CHU-ANGERS | Angers | 49933 | France | |||
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| Waves perfusion device | Device | Renal Perfusion with Waves perfusion device |
|
|
| 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 |
| Coordination Hospitalière de PMO-Anestésiste -réanimateur, CHU-Bordeaux -GROUPE HOSPITALIER PELLEGRIN DAR I |
| Bordeaux |
| 33076 |
| France |
| CHD-Vendée-Les Oudairies | La Roche-sur-Yon | 85925 | France |
| Coordination des prélèvements d'organes et de Tissus- CHU-Limoges -CHU- DUPUYTREN | Limoges | 84042 | France |
| Chirurgien-Chirurgie de la transplantation et d'Urologie, Pavillon V, Hôpital Edouard HERRIOT | Lyon | 69003 | France |
| Coordination des prélèvements d'organes et de Tissus,CHU-NANTES | Nantes | 44093 | France |
| Coordination des prélèvements d'organes et de Tissus Pôle Anesthésie-Réanimations,University Hospital | Tours | 37044 | France |