Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors

Not Applicable

Completed

• Conditions: Chronic Renal Failure
• Interventions: Procedure: Pulsatile perfusion; Procedure: Static incubation

• Registration Number: NCT01170910
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Our hypothesis is that the Waters Medical® pulsatile perfusion machine (RM 3) is a way to improve delayed graft function (DGF) in marginal grafts, and some perfusion profiles (flow, pressure, resistance index, venous effluent pH) are correlated with better recovery of renal function (without dialysis during the first week after transplant).

Observation or Investigation Method Used :

The study is multicenter, prospective, open, controlled and randomized:grafts are divided into two parallel groups:

* group 1 corresponds to a conservation of grafts in static incubation

* group 2 corresponds to conservation using a pulsatile perfusion machine

Duration and Organizational Arrangements for Research :

The total duration of the study is planned for 36 months. This duration includes:

* an inclusion period that will last 24 months,

* the follow-up of recipient patients from the day of transplantation until twelve months after the operation

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Primary Completion: 2015-08
• Study Completion: 2016-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-29
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsatile perfusion	Pulsatile perfusion	If conservation in a pulsatile perfusion machine (group 2) is chosen by random selection, the kidney will be placed in the perfusion machine within two hours and should be kept there at least 6 hours and 8 hours if possible, before being transplanted
Static incubation	Static incubation	If conservation in static incubation (group 1) is chosen by random selection, the transplant should be carried out while keeping the cold ischemic time (CIT) as short as possible (preferably less than 18 hours). Keep in mind that for reasons of homogeneity for result analysis and for conservation quality, it is recommended that kidneys in group 1 be conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution.

Primary Outcome Measures

Name	Time	Method
Delayed graft function (DGF) rate defined as the need to resort to dialysis during the first week after transplantation. The main dialysis factors retained are hydrosodic and/or hyperkalemic overload.	First week after transplantation

Secondary Outcome Measures

Name	Time	Method
Evaluate improvement in the glomerular filtering rate	12 months after transplantation
Evaluate the recourse to dialysis	3 months following transplantation
Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis)	12 months after transplantation
Evaluate patient survival	12 months after transplantation
Stratify the analysis of regaining function and graft survival using Nyberg's classification in order to determine which risk groups would most benefit from pulsatile perfusion.	12 months after transplantation
Evaluate the medico-economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts	12 months after transplantation
Identify perfusion profiles of the machine, which predict regaining renal function (absence of dialysis during the week after transplantation) and graft survival	12 months after transplantation

Trial Locations

Locations (1)

Service d'Urologie et Chirurgie de la Tranplantation - Hôpital Edourad Herriot; 🇫🇷 Lyon, France