Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors

Chronic Renal Failure Clinical Trial

— IMPULSION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170910
• Other study ID #: 2009.550/3
• Status: Completed
• Phase: N/A
• First received: July 26, 2010
• Last updated: May 29, 2017
• Start date: April 2010
• Est. completion date: August 2016

Study information

• Verified date: May 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Service d'Urologie et Chirurgie de la Tranplantation - Hôpital Edourad Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate improvement in the glomerular filtering rate		12 months after transplantation
Secondary	Evaluate the recourse to dialysis		3 months following transplantation
Secondary	Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis)		12 months after transplantation
Secondary	Evaluate patient survival		12 months after transplantation
Secondary	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
Secondary	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
Secondary	Evaluate the medico-economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts		12 months after transplantation