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

R

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Kidney
Transplantation

Treatments

Device: LifePort® perfusion device
Device: Waves perfusion device

Study type

Observational

Funder types

Other

Identifiers

NCT02826213
PHRI14-JCV-RENOMAP

Details and patient eligibility

About

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

Full 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.

Enrollment

228 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

228 participants in 2 patient groups

Kidney : perfusion device lifeport
Description:
Each donor (n=140) will provide one kidney for pulsatile perfusion.
Treatment:
Device: LifePort® perfusion device
Kidney : perfusion device waves
Description:
Each donor (n=140) will provide one kidney for continuous perfusion.
Treatment:
Device: Waves perfusion device

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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