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

Sponsor
University Hospital, Tours (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02826213
Collaborator
(none)
280
Enrollment
7
Locations
45.1
Anticipated Duration (Months)
40
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
280 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient: Multicentre Randomized Trial
Actual Study Start Date :
Nov 29, 2017
Anticipated Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    2. RFG [1 month]

      Absence of a recovery renal function at 1 month.

    3. MDRD [1 year]

      Modification of Diet in Renal the Disease at 1 year

    4. GSR [1 year]

      graft survival rate at 1 year.

    5. Renal Biopsie results [3 months]

      Results of analyzes of kidney biopsies punctures to 3 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • University Hospital, Tours

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Tours
    ClinicalTrials.gov Identifier:
    NCT02826213
    Other Study ID Numbers:
    • PHRI14-JCV-RENOMAP
    First Posted:
    Jul 7, 2016
    Last Update Posted:
    Sep 25, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University Hospital, Tours
    Renal infusion
    Renal infusion device

    Study Results

    No Results Posted as of Sep 25, 2020