Metabolomics in Assessing the Quality of Kidney Transplants Retained on a LifePort® Perfusion Machine

Study Overview
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Brief Summary
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When the kidneys are perfused on perfusion machines before transplantation, the resistance parameters as well as the histological score on the pre-implantation biopsy participate in the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could provide additional evidence.

Detailed Description
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The quality of the renal transplant prior to transplantation is essential for the recovery of graft function in the days following transplantation and its long-term survival. When the kidneys are perfused on perfusion machines before transplantation, the resistance parameters as well as the histological score on the pre-implantation biopsy participate in the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could provide additional evidence.

Official Title
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The Importance of Metabolomics in Assessing the Quality of Kidney Transplants Retained on a LifePort® Perfusion Machine Before Renal Transplantation

Conditions
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Renal Transplantation

Intervention / Treatment
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* Device: LifePort® perfusion machine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Donors aged 18 years or more in brain death or who died of cardiac arrest collected locally in Tours, associated with the major local recipients of the grafts over the same period. Exclusion Criteria: Kidney transplant removed but stored in a static preservative. Kidney grafts of donors aged 18 years or more, removed and not retained on a LifePort® perfusion machine.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Metabolic assessment in Urine and perfusion liquids
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LifePort® perfusion machine<br>Metabolomic analysis of the preservation fluid of the graft, donor and recipient urine by nuclear magnetic resonance spectroscopy, and if possible by liquid and gas chromatography coupled with mass spectrometry. | Device: LifePort® perfusion machine<br>* Renal perfusion on LifePort® machine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF | Immediate Graft Function (IGF), defined by serum creatinine less than 250 μM / L at day 7 post-kidney transplant, without requiring dialysis of the recipient patient. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DGF | DGF Delayed graft function : Dialysis need within 7 days post-transplant | 7 days | 
| BANFF-1 | Anatomo-pathological classification of the pre-implantation biopsy according to the revised Banff classification 2013 | PRE-OPERATIONAL | 
| BANFF-2 | Anatomo-pathological classification of systematic biopsy at 3 months post-transplant according to the revised Banff classification 2013 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplantation;perfusion machine