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Kidney transplantation (KT) has emerged as the mainstay of treatment for end-stage kidney disease. In an effort to address the widening gap between demand and supply of donor organs, there has been an increase in the numbers of "marginal" or functionally impaired renal allografts that had to be accepted for KT over the decades. The use of extended criteria donor (ECD) allografts is associated with a higher incidence of primary graft non-function (PNF) and/or delayed graft function (DGF). Hypothermic oxygenated machine perfusion (HOPE) has been successfully tested in pre-clinical experiments and in a few clinical series of donation after cardiac death (DCD) in liver transplantation. The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in donation after brain death (DBD) KT. Fifteen kidney allografts will be submitted to 2 hours of HOPE before implantation and are going to be compared to a case matched group transplanted after conventional cold storage (CCS).
The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in DBD KT. Fifteen kidney allografts with defined inclusion/exclusion criteria will be submitted to 2 hours of HOPE via the renal artery before implantation and are going to be compared to a case matched group of 30 patients (1:2 matching) transplanted after CCS. Besides the clinical evaluation of HOPE-"reconditioned" allograft function, a targeted biomarker analysis is planned using tissue, serum, and urine samples as the translational and basic research aspect of the present study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional cold storage | Active Comparator | Conventional static cold storage (CCS) on temperature 0-4 °C from organ procurement (historical case matched group) |
|
| Hypothermic oxygenated perfusion (HOPE) | Experimental | HOPE for 1 hour via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HOPE | Procedure | HOPE for 1 hour via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP) |
| Measure | Description | Time Frame |
|---|---|---|
| DGF | DGF (defined as the need for dialysis in the first 7-days post-transplantation) | 7 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| CRR2, CRR5 | Creatinine reduction ratio day 2 (CRR2= creatinine day 1-creatinine day 2/creatinine day 1) and CRR5 (CRR5=pre-transplant creatinine-creatinine day 5/pre-transplant creatinine) | 5 days post-transplant |
| postoperative complications |
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Inclusion Criteria:
Dialysis-requiring Patients, suffering from end stage kidney disease, listed for KT and receiving ECD organs at the Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany. Informed consent is obtained from all subjects participating in the trial by a qualified member of the study team.
ECD is defined as followed: deceased donors > 60 years and older, and those aged between 50-59 years with at least two of the following conditions: cerebrovascular cause of death, serum Creatinine greater than 1.5 mg/dL (132.6 µmol/L), history of arterial hypertension
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georg Lurje, M.D. | RWTH Aachen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery and Transplantation, University Hospital RWTH Aachen | Aachen | 52074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33082420 | Derived | Meister FA, Czigany Z, Rietzler K, Miller H, Reichelt S, Liu WJ, Boecker J, Moeller MJ, Tolba RH, Hamesch K, Strnad P, Boor P, Stoppe C, Neumann UP, Lurje G. Decrease of renal resistance during hypothermic oxygenated machine perfusion is associated with early allograft function in extended criteria donation kidney transplantation. Sci Rep. 2020 Oct 20;10(1):17726. doi: 10.1038/s41598-020-74839-7. | |
| 31613224 |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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Pilot study, case matched (1:2)
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| Conventional cold storage | Other | No intervention |
|
Clavien-Dindo complication score
| Subjects will be followed 6 months postoperatively |
| Cumulative postoperative complications | Comprehensive complication index (CCI) | Subjects will be followed 6 months postoperatively |
| Duration of intensive care stay | Duration of ICU stay | Subjects will be followed 6 months postoperatively |
| Duration of hospital stay | Duration of hospitalisation | Subjects will be followed 6 months postoperatively |
| Graft survival | Six months graft survival | Subjects will be followed 6 months postoperatively |
| Renal function | Renal function (serum creatinine and estimated glomerular filtration rate (eGFR)) | Subjects will be followed 6 months postoperatively |
| Perfusion Parameter | Flow and thus renal resistance | During HOPE |
| Derived |
| Meister FA, Czigany Z, Bednarsch J, Bocker J, Amygdalos I, Morales Santana DA, Rietzler K, Moeller M, Tolba R, Boor P, Rohlfs W, Neumann UP, Lurje G. Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts from Brain Dead Donors: Protocol for a Prospective Pilot Study. JMIR Res Protoc. 2019 Oct 14;8(10):e14622. doi: 10.2196/14622. |
| D013568 | Pathological Conditions, Signs and Symptoms |