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

Primary Purpose

Chronic Renal Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Static incubation
Pulsatile perfusion
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Renal Failure focused on measuring Chronic renal failure, Transplantation, Marginal kidney graft, Pulsatile perfusion machine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Static incubation

Pulsatile perfusion

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluate improvement in the glomerular filtering rate
Evaluate the recourse to dialysis
Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis)
Evaluate patient survival
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.
Identify perfusion profiles of the machine, which predict regaining renal function (absence of dialysis during the week after transplantation) and graft survival
Evaluate the medico-economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts

Full Information

First Posted
July 26, 2010
Last Updated
May 29, 2017
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01170910
Brief Title
Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors
Acronym
IMPULSION
Official Title
Interest of Pulsatile Perfusion Preservation on Outcomes in Kidney Transplantation From Expanded Criteria Donors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
Chronic renal failure, Transplantation, Marginal kidney graft, Pulsatile perfusion machine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Static incubation
Arm Type
Other
Arm 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.
Arm Title
Pulsatile perfusion
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Static incubation
Intervention Description
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
Intervention Name(s)
Pulsatile perfusion
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Time Frame
First week after transplantation
Secondary Outcome Measure Information:
Title
Evaluate improvement in the glomerular filtering rate
Time Frame
12 months after transplantation
Title
Evaluate the recourse to dialysis
Time Frame
3 months following transplantation
Title
Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis)
Time Frame
12 months after transplantation
Title
Evaluate patient survival
Time Frame
12 months after transplantation
Title
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.
Time Frame
12 months after transplantation
Title
Identify perfusion profiles of the machine, which predict regaining renal function (absence of dialysis during the week after transplantation) and graft survival
Time Frame
12 months after transplantation
Title
Evaluate the medico-economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts
Time Frame
12 months after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Service d'Urologie et Chirurgie de la Tranplantation - Hôpital Edourad Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France

12. IPD Sharing Statement

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Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors

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