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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

228 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-29

Study Completion Date

2021-09-01

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

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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.

Conditions

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Transplantation Kidney

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Kidney : perfusion device lifeport

Each donor (n=140) will provide one kidney for pulsatile perfusion.

LifePort® perfusion device

Intervention Type DEVICE

Renal Perfusion with LifePort® perfusion device

Kidney : perfusion device waves

Each donor (n=140) will provide one kidney for continuous perfusion.

Waves perfusion device

Intervention Type DEVICE

Renal Perfusion with Waves perfusion device

Interventions

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LifePort® perfusion device

Renal Perfusion with LifePort® perfusion device

Intervention Type DEVICE

Waves perfusion device

Renal Perfusion with Waves perfusion device

Intervention Type DEVICE

Other Intervention Names

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A B

Eligibility Criteria

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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).

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No