Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors

NCT ID: NCT01170910

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2016-08-31

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

Conditions

Chronic Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Static incubation

Intervention Type: PROCEDURE

Kidneys in this group are conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution before being transplanted.

.

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

Group Type: EXPERIMENTAL

Pulsatile perfusion

Intervention Type: PROCEDURE

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

Interventions

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.

.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service d'Urologie et Chirurgie de la Tranplantation - Hôpital Edourad Herriot

Lyon, , France

Countries

France

References

Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.

Reference Type: DERIVED

PMID: 38979743 (View on PubMed)

Other Identifiers

2009.550/3

Identifier Type: -

Identifier Source: org_study_id