NCT01170910

Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors

Interest of Pulsatile Perfusion Preservation on Outcomes in Kidney Transplantation From Expanded Criteria Donors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Renal Failure

Interventions

Type	Name	Description
PROCEDURE	Static incubation	Kidneys in this group are conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution before being transplanted. .
PROCEDURE	Pulsatile perfusion	Kidneys in this group are placed in the pulsatile perfusion machine(RM 3) within two hours and should be kept there at least 6 hours and 8 hours if possible, before being transplanted

Timeline

• Start date: 2010-04-01
• Primary completion: 2015-08-01
• Completion: 2016-08-01
• First posted: 2010-07-27
• Last updated: 2017-05-31

Locations

1 site across 1 country: France