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Completed

NCT Number: NCT02826213

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

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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Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Coordination Hospitalière de PMO , Pôle USSAR-Anestéthésie -Réa CHU-ANGERS, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

LifePort® perfusion device

Device

Renal Perfusion with LifePort® perfusion device

Other names: A

Waves perfusion device

Device

Renal Perfusion with Waves perfusion device

Other names: B

Primary outcomes

  1. Glomerular Filtration Rate

    Time frame: 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 outcomes

  1. Creatinine <250 mg / dL

    Time frame: 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

    Time frame: 1 month

    Absence of a recovery renal function at 1 month.

  3. MDRD

    Time frame: 1 year

    Modification of Diet in Renal the Disease at 1 year

  4. GSR

    Time frame: 1 year

    graft survival rate at 1 year.

  5. Renal Biopsie results

    Time frame: 3 months

    Results of analyzes of kidney biopsies punctures to 3 months.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: RENOMAP

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2016
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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