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

This study is currently recruiting participants.
Verified July 2011 by Hospices Civils de Lyon
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01170910
First received: July 26, 2010
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

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

Condition Intervention Phase
Chronic Renal Failure
 Procedure: Static incubation
Procedure: Pulsatile perfusion
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Interest of Pulsatile Perfusion Preservation on Outcomes in Kidney Transplantation From Expanded Criteria Donors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

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. [ Time Frame: First week after transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate improvement in the glomerular filtering rate [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: Yes ]
  • Evaluate the recourse to dialysis [ Time Frame: 3 months following transplantation ] [ Designated as safety issue: Yes ]
  • Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis) [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: Yes ]
  • Evaluate patient survival [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170910

Contacts
Contact: Lionel BADET 472110538 ext +33 lionel.badet@chu-lyon.fr
Contact: Laurent VILLENEUVE 478864536 ext +33 laurent.villeneuve@chu-lyon.fr

Locations
France
Service d'Urologie et Chirurgie de la Tranplantation - Hôpital Edourad Herriot Recruiting
Lyon, France, 69437
Contact: Lionel BADET     472110538 ext +33     lionel.badet@chu-lyon.fr    
Principal Investigator: Lionel BADET            
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pr Lionel BADET, Hospices Civils de Lyon : Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Lyon
ClinicalTrials.gov Identifier: NCT01170910     History of Changes
Other Study ID Numbers: 2009.550/3
Study First Received: July 26, 2010
Last Updated: July 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Chronic renal failure
Transplantation
Marginal kidney graft
Pulsatile perfusion machine

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 17, 2012