Kidney, Transplantation
Conditions
Keywords
Renal infusion, Renal infusion device
Brief summary
Comparison of two techniques of renal pre-transplant infusion on the evolution of renal function in the recipient: multicentre randomized trial
Detailed description
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.
Interventions
DEVICELifePort® perfusion device
Renal Perfusion with LifePort® perfusion device
DEVICEWaves perfusion device
Renal Perfusion with Waves perfusion device
Sponsors
University Hospital, Tours
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glomerular Filtration Rate | 3 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine <250 mg / dL | 1 week | Time for obtaining a serum creatinine \<250 mg / dL and need for dialysis in recovery during the first seven days post transplant. |
| RFG | 1 month | Absence of a recovery renal function at 1 month. |
| MDRD | 1 year | Modification of Diet in Renal the Disease at 1 year |
| GSR | 1 year | graft survival rate at 1 year. |
| Renal Biopsie results | 3 months | Results of analyzes of kidney biopsies punctures to 3 months. |
Countries
France
Outcome results
None listed