Clinical trial NCT02826213: Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient
Official title: Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient: Multicentre Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplantation
Kidney
Keywords: Renal infusion
Renal infusion device
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 228
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: RENAL Donors and recipients

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.

Eligibility 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).

Primary outcomes:
measure: Glomerular Filtration Rate
timeFrame: 3 months
Secondary outcomes:
measure: Creatinine <250 mg / dL
timeFrame: 1 week
measure: RFG
timeFrame: 1 month
measure: MDRD
timeFrame: 1 year
measure: GSR
timeFrame: 1 year
measure: Renal Biopsie results
timeFrame: 3 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Coordination Hospitalière de PMO , Pôle USSAR-Anestéthésie -Réa CHU-ANGERS
city: Bordeaux
country: France
facility: Coordination Hospitalière de PMO-Anestésiste -réanimateur, CHU-Bordeaux -GROUPE HOSPITALIER PELLEGRIN DAR I
city: La Roche-sur-Yon
country: France
facility: CHD-Vendée-Les Oudairies
city: Limoges
country: France
facility: Coordination des prélèvements d'organes et de Tissus- CHU-Limoges -CHU- DUPUYTREN
city: Lyon
country: France
facility: Chirurgien-Chirurgie de la transplantation et d'Urologie, Pavillon V, Hôpital Edouard HERRIOT
city: Nantes
country: France
facility: Coordination des prélèvements d'organes et de Tissus,CHU-NANTES
city: Tours
country: France
facility: Coordination des prélèvements d'organes et de Tissus Pôle Anesthésie-Réanimations,University Hospital
Study officials:
affiliation: University Hospital, Tours
name: Jean-Christophe VENHARD, MD-PhD
role: STUDY_DIRECTOR
References: