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Completed

NCT Number: NCT01170910

Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors

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

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Key information

Conditions

Chronic Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Static incubation

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

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

Primary outcomes

  1. 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 outcomes

  1. Evaluate improvement in the glomerular filtering rate

    Time frame: 12 months after transplantation

  2. Evaluate the recourse to dialysis

    Time frame: 3 months following transplantation

  3. Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis)

    Time frame: 12 months after transplantation

  4. Evaluate patient survival

    Time frame: 12 months after transplantation

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: IMPULSION

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Jul 27, 2010
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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