Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors

NCT01170910 | Completed DMC

• 1 other identifier: 2009.550/3
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Renal Failure

Keywords

Chronic renal failure; Transplantation; Marginal kidney graft; Pulsatile perfusion machine

Outcome Measures

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.

  First week after transplantation

Secondary Outcomes (7)

• Evaluate improvement in the glomerular filtering rate

  12 months after transplantation

• Evaluate the recourse to dialysis

  3 months following transplantation

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

  12 months after transplantation

• Evaluate patient survival

  12 months after transplantation

• 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

Study Arms (2)

Static incubation

OTHER

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

Pulsatile perfusion

EXPERIMENTAL

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

Interventions

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. .

Static incubation

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

Pulsatile perfusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• patients registered on the kidney transplant waiting list likely to receive a marginal kidney
• immunized patients whose anti-HLA antibody specificities have been determined

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Lyon, 69437, France

Location

Related Publications (1)

• Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.

  PMID: 38979743 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Pulsatile Flow

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motion; Physical Phenomena; Hemorheology; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 27, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

FR (1)