Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors (IMPULSION)

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Renal Failure
• Intervention / Treatment: Procedure: Static incubation; Procedure: Pulsatile perfusion

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69437
    • Service d'Urologie et Chirurgie de la Tranplantation - Hôpital Edourad Herriot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria for marginal graft:

• donors over 60 years of age

• donors between 50 and 60 years of age with at least one of the following characteristics :

  • history of diabetes mellitus
  • history of high blood pressure
  • serum creatinine >1,5 mg/dL
  • death by stroke (haemorrhagic or thrombotic)

Inclusion criteria for recipient :

• patients registered on the kidney transplant waiting list likely to receive a marginal kidney
• immunized patients whose anti-HLA antibody specificities have been determined

Exclusion Criteria for recipient:

• pregnant or breastfeeding women
• people who have been incarcerated
• minors
• adults under guardianship
• people who are not affiliated with the French healthcare system
• people with HLA immunization whose HLA antibody specificities have not been determined

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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. .
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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
Evaluate the medico-economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts	12 months after transplantation

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (Estimate): July 27, 2010

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 29, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Transplantation; Chronic renal failure; Marginal kidney graft; Pulsatile perfusion machine
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 2009.550/3