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Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors

NCT01170910 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2017-05-31

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-08-31
Completion
2016-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01170910 on ClinicalTrials.gov