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

Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient: Multicentre Randomized Trial

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

Study Overview

• Status: Completed
• Conditions: Transplantation; Kidney
• Intervention / Treatment: Device: LifePort® perfusion device; Device: Waves perfusion device

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.

• Study Type: Observational
• Enrollment (Actual): 228

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Coordination Hospitalière de PMO , Pôle USSAR-Anestéthésie -Réa CHU-ANGERS
  • Bordeaux, France, 33076
    • Coordination Hospitalière de PMO-Anestésiste -réanimateur, CHU-Bordeaux -GROUPE HOSPITALIER PELLEGRIN DAR I
  • La Roche-sur-Yon, France, 85925
    • CHD-Vendée-Les Oudairies
  • Limoges, France, 84042
    • Coordination des prélèvements d'organes et de Tissus- CHU-Limoges -CHU- DUPUYTREN
  • Lyon, France, 69003
    • Chirurgien-Chirurgie de la transplantation et d'Urologie, Pavillon V, Hôpital Edouard HERRIOT
  • Nantes, France, 44093
    • Coordination des prélèvements d'organes et de Tissus,CHU-NANTES
  • Tours, France, 37044
    • Coordination des prélèvements d'organes et de Tissus Pôle Anesthésie-Réanimations,University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

RENAL Donors and recipients

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Kidney : perfusion device lifeport; Each donor (n=140) will provide one kidney for pulsatile perfusion.	Device: LifePort® perfusion device; Renal Perfusion with LifePort® perfusion device; Other Names: A
Kidney : perfusion device waves; Each donor (n=140) will provide one kidney for continuous perfusion.	Device: Waves perfusion device; Renal Perfusion with Waves perfusion device; Other Names: B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Study Director: Jean-Christophe VENHARD, MD-PhD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2017
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Renal infusion; Renal infusion device
• Other Study ID Numbers: PHRI14-JCV-RENOMAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No