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

Not Applicable

Completed

• Conditions: Renal Transplantation
• Interventions: Device: LifePort® perfusion machine

• Registration Number: NCT03024229
• Lead Sponsor: University Hospital, Tours

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Study Start: 2017-03-15
• Primary Completion: 2019-09-15
• Status Verified: 2020-01
• Study Completion: 2020-01-14
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LifePort® perfusion machine	LifePort® perfusion machine	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.

Primary Outcome Measures

Name	Time	Method
IGF	7 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CHR-ORLEANS Service d'Urologie; 🇫🇷 Orléans, Loiret, France

Urology CHRU-TOURS; 🇫🇷 Tours, I&L, France