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Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial

INTRODUCTION: Ageing of the general population has led to an increase in the use of suboptimal kidneys from expanded criteria donation after brain death (ECD-DBD) and donation after circulatory death (DCD) donors. However, these kidneys have inferior graft outcomes and lower rates of immediate funct...

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Autores principales: Rijkse, Elsaline, Bouari, Sarah, Kimenai, Hendrikus J. A. N., de Jonge, Jeroen, de Bruin, Ron W. F., Slagter, Julia S., van den Hoogen, Martijn W. F., IJzermans, Jan N. M., Hoogduijn, Martin J., Minnee, Robert C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: IJS Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8499718/
https://www.ncbi.nlm.nih.gov/pubmed/34708171
http://dx.doi.org/10.29337/ijsp.165
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author Rijkse, Elsaline
Bouari, Sarah
Kimenai, Hendrikus J. A. N.
de Jonge, Jeroen
de Bruin, Ron W. F.
Slagter, Julia S.
van den Hoogen, Martijn W. F.
IJzermans, Jan N. M.
Hoogduijn, Martin J.
Minnee, Robert C.
author_facet Rijkse, Elsaline
Bouari, Sarah
Kimenai, Hendrikus J. A. N.
de Jonge, Jeroen
de Bruin, Ron W. F.
Slagter, Julia S.
van den Hoogen, Martijn W. F.
IJzermans, Jan N. M.
Hoogduijn, Martin J.
Minnee, Robert C.
author_sort Rijkse, Elsaline
collection PubMed
description INTRODUCTION: Ageing of the general population has led to an increase in the use of suboptimal kidneys from expanded criteria donation after brain death (ECD-DBD) and donation after circulatory death (DCD) donors. However, these kidneys have inferior graft outcomes and lower rates of immediate function. Normothermic machine perfusion (NMP) may improve outcomes of these suboptimal donor kidneys. Previous non-randomized studies have shown the safety of this technique and suggested its efficacy in improving the proportion of immediate functioning kidneys compared to static cold storage (SCS). However, its additional value to hypothermic machine perfusion (HMP), which has already been proved superior to SCS, has not yet been established. METHODS AND ANALYSIS: This single-center, open-label, randomized controlled trial aims to assess immediate kidney function after 120 minutes additional, end-ischemic NMP compared to HMP alone. Immediate kidney function is defined as no dialysis treatment in the first week after transplant. Eighty recipients on dialysis at the time of transplant who receive an ECD-DBD or DCD kidney graft are eligible for inclusion. In the NMP group, the donor kidney is taken of HMP upon arrival in the recipient hospital and thereafter put on NMP for 120 minutes at 37 degrees Celsius followed by transplantation. In the control group, donor kidneys stay on HMP until transplantation. The primary outcome is immediate kidney function. ETHICS AND DISSEMINATION: The protocol has been approved by the Medical Ethical Committee of Erasmus Medical Center (2020-0366). Results of this study will be submitted to peer-reviewed journals. REGISTRATION: registered in clinicaltrials.gov (NCT04882254). HIGHLIGHTS: This is the first RCT to compare additional NMP to HMP alone. Extensive sampling will offer in-depth analysis of kidney physiology during NMP. This RCT may help identify biomarkers to predict clinical outcomes during NMP. Biomarkers can help develop NMP as assessment tool for declined kidneys.
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spelling pubmed-84997182021-10-26 Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial Rijkse, Elsaline Bouari, Sarah Kimenai, Hendrikus J. A. N. de Jonge, Jeroen de Bruin, Ron W. F. Slagter, Julia S. van den Hoogen, Martijn W. F. IJzermans, Jan N. M. Hoogduijn, Martin J. Minnee, Robert C. Int J Surg Protoc Protocol INTRODUCTION: Ageing of the general population has led to an increase in the use of suboptimal kidneys from expanded criteria donation after brain death (ECD-DBD) and donation after circulatory death (DCD) donors. However, these kidneys have inferior graft outcomes and lower rates of immediate function. Normothermic machine perfusion (NMP) may improve outcomes of these suboptimal donor kidneys. Previous non-randomized studies have shown the safety of this technique and suggested its efficacy in improving the proportion of immediate functioning kidneys compared to static cold storage (SCS). However, its additional value to hypothermic machine perfusion (HMP), which has already been proved superior to SCS, has not yet been established. METHODS AND ANALYSIS: This single-center, open-label, randomized controlled trial aims to assess immediate kidney function after 120 minutes additional, end-ischemic NMP compared to HMP alone. Immediate kidney function is defined as no dialysis treatment in the first week after transplant. Eighty recipients on dialysis at the time of transplant who receive an ECD-DBD or DCD kidney graft are eligible for inclusion. In the NMP group, the donor kidney is taken of HMP upon arrival in the recipient hospital and thereafter put on NMP for 120 minutes at 37 degrees Celsius followed by transplantation. In the control group, donor kidneys stay on HMP until transplantation. The primary outcome is immediate kidney function. ETHICS AND DISSEMINATION: The protocol has been approved by the Medical Ethical Committee of Erasmus Medical Center (2020-0366). Results of this study will be submitted to peer-reviewed journals. REGISTRATION: registered in clinicaltrials.gov (NCT04882254). HIGHLIGHTS: This is the first RCT to compare additional NMP to HMP alone. Extensive sampling will offer in-depth analysis of kidney physiology during NMP. This RCT may help identify biomarkers to predict clinical outcomes during NMP. Biomarkers can help develop NMP as assessment tool for declined kidneys. IJS Publishing Group 2021-10-06 /pmc/articles/PMC8499718/ /pubmed/34708171 http://dx.doi.org/10.29337/ijsp.165 Text en Copyright: © 2021 The Author(s) https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC-BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. See http://creativecommons.org/licenses/by/4.0/.
spellingShingle Protocol
Rijkse, Elsaline
Bouari, Sarah
Kimenai, Hendrikus J. A. N.
de Jonge, Jeroen
de Bruin, Ron W. F.
Slagter, Julia S.
van den Hoogen, Martijn W. F.
IJzermans, Jan N. M.
Hoogduijn, Martin J.
Minnee, Robert C.
Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial
title Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial
title_full Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial
title_fullStr Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial
title_full_unstemmed Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial
title_short Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial
title_sort additional normothermic machine perfusion versus hypothermic machine perfusion in suboptimal donor kidney transplantation: protocol of a randomized, controlled, open-label trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8499718/
https://www.ncbi.nlm.nih.gov/pubmed/34708171
http://dx.doi.org/10.29337/ijsp.165
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