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

Civil Hospices of Lyon

Status: Completed

Conditions: Chronic Renal Failure

Treatments: Procedure: Static incubation; Procedure: Pulsatile perfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01170910

2009.550/3

Details and patient eligibility

About

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

Enrollment: 162 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Static incubation

Other group

Description:

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.

Treatment:

Procedure: Static incubation

Pulsatile perfusion

Experimental group

Description:

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

Treatment:

Procedure: Pulsatile perfusion