Clinical trial NCT01170910: Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors
Official title: Interest of Pulsatile Perfusion Preservation on Outcomes in Kidney Transplantation From Expanded Criteria Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Failure
Keywords: Chronic renal failure
Transplantation
Marginal kidney graft
Pulsatile perfusion machine
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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

Primary outcomes:
measure: 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.
timeFrame: First week after transplantation
Secondary outcomes:
measure: Evaluate improvement in the glomerular filtering rate
timeFrame: 12 months after transplantation
measure: Evaluate the recourse to dialysis
timeFrame: 3 months following transplantation
measure: Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis)
timeFrame: 12 months after transplantation
measure: Evaluate patient survival
timeFrame: 12 months after transplantation
measure: 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.
timeFrame: 12 months after transplantation
measure: Identify perfusion profiles of the machine, which predict regaining renal function (absence of dialysis during the week after transplantation) and graft survival
timeFrame: 12 months after transplantation
measure: Evaluate the medico-economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts
timeFrame: 12 months after transplantation
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service d'Urologie et Chirurgie de la Tranplantation - Hôpital Edourad Herriot
Study officials:
References: