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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:
Duration and Organizational Arrangements for Research :
The total duration of the study is planned for 36 months. This duration includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. . |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate improvement in the glomerular filtering rate | 12 months after transplantation | |
| Evaluate the recourse to dialysis | 3 months following transplantation | |
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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 :
Inclusion criteria for recipient :
Exclusion Criteria for recipient:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Urologie et Chirurgie de la Tranplantation - Hôpital Edourad Herriot | Lyon | 69437 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38979743 | Derived | 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. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D011673 | Pulsatile Flow |
| ID | Term |
|---|---|
| D009038 | Motion |
| D055585 | Physical Phenomena |
| D018056 | Hemorheology |
| D006439 | Hemodynamics |
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| 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 |
|
| 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 |
| Identify perfusion profiles of the machine, which predict regaining renal function (absence of dialysis during the week after transplantation) and graft survival | 12 months after transplantation |
| Evaluate the medico-economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts | 12 months after transplantation |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002320 |
| Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |