Oxygenated End-Hypothermic Machine Perfusion in Expanded Criteria Donor Kidney Transplant : A Randomized Clinical Trial
Importance: Continuous hypothermic machine perfusion during organ preservation has a beneficial effect on graft function and survival in kidney transplant when compared with static cold storage (SCS).
Objective: To compare the effect of short-term oxygenated hypothermic machine perfusion preservation (end-HMPo2) after SCS vs SCS alone on 1-year graft survival in expanded criteria donor kidneys from donors who are brain dead.
Design, Setting, and Participants: In a prospective, randomized, multicenter trial, kidneys from expanded criteria donors were randomized to either SCS alone or SCS followed by end-HMPo2 prior to implantation with a minimum machine perfusion time of 120 minutes. Kidneys were randomized between January 2015 and May 2018, and analysis began May 2019. Analysis was intention to treat.
Interventions: On randomization and before implantation, deceased donor kidneys were either kept on SCS or placed on HMPo2.
Main Outcome and Measures: Primary end point was 1-year graft survival, with delayed graft function, primary nonfunction, acute rejection, estimated glomerular filtration rate, and patient survival as secondary end points.
Results: Centers in 5 European countries randomized 305 kidneys (median [range] donor age, 64 [50-84] years), of which 262 kidneys (127 [48.5%] in the end-HMPo2 group vs 135 [51.5%] in the SCS group) were successfully transplanted. Median (range) cold ischemia time was 13.2 (5.1-28.7) hours in the end-HMPo2 group and 12.9 (4-29.2) hours in the SCS group; median (range) duration in the end-HMPo2 group was 4.7 (0.8-17.1) hours. One-year graft survival was 92.1% (n = 117) in the end-HMPo2 group vs 93.3% (n = 126) in the SCS group (95% CI, -7.5 to 5.1; P = .71). The secondary end point analysis showed no significant between-group differences for delayed graft function, primary nonfunction, estimated glomerular filtration rate, and acute rejection.
Conclusions and Relevance: Reconditioning of expanded criteria donor kidneys from donors who are brain dead using end-HMPo2 after SCS does not improve graft survival or function compared with SCS alone. This study is underpowered owing to the high overall graft survival rate, limiting interpretation.
Trial Registration: isrctn.org Identifier: ISRCTN63852508.
| Errataetall: |
CommentIn: Transpl Int. 2021 Sep;34(9):1583-1585. - PMID 34448262 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:156 |
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| Enthalten in: |
JAMA surgery - 156(2021), 6 vom: 01. Juni, Seite 517-525 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Husen, Peri [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 26.01.2022 Date Revised 23.04.2022 published: Print CommentIn: Transpl Int. 2021 Sep;34(9):1583-1585. - PMID 34448262 Citation Status MEDLINE |
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| doi: |
10.1001/jamasurg.2021.0949 |
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| funding: |
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| PPN (Katalog-ID): |
NLM324357966 |
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| 100 | 1 | |a Husen, Peri |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Oxygenated End-Hypothermic Machine Perfusion in Expanded Criteria Donor Kidney Transplant |b A Randomized Clinical Trial |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Completed 26.01.2022 | ||
| 500 | |a Date Revised 23.04.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a CommentIn: Transpl Int. 2021 Sep;34(9):1583-1585. - PMID 34448262 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Importance: Continuous hypothermic machine perfusion during organ preservation has a beneficial effect on graft function and survival in kidney transplant when compared with static cold storage (SCS) | ||
| 520 | |a Objective: To compare the effect of short-term oxygenated hypothermic machine perfusion preservation (end-HMPo2) after SCS vs SCS alone on 1-year graft survival in expanded criteria donor kidneys from donors who are brain dead | ||
| 520 | |a Design, Setting, and Participants: In a prospective, randomized, multicenter trial, kidneys from expanded criteria donors were randomized to either SCS alone or SCS followed by end-HMPo2 prior to implantation with a minimum machine perfusion time of 120 minutes. Kidneys were randomized between January 2015 and May 2018, and analysis began May 2019. Analysis was intention to treat | ||
| 520 | |a Interventions: On randomization and before implantation, deceased donor kidneys were either kept on SCS or placed on HMPo2 | ||
| 520 | |a Main Outcome and Measures: Primary end point was 1-year graft survival, with delayed graft function, primary nonfunction, acute rejection, estimated glomerular filtration rate, and patient survival as secondary end points | ||
| 520 | |a Results: Centers in 5 European countries randomized 305 kidneys (median [range] donor age, 64 [50-84] years), of which 262 kidneys (127 [48.5%] in the end-HMPo2 group vs 135 [51.5%] in the SCS group) were successfully transplanted. Median (range) cold ischemia time was 13.2 (5.1-28.7) hours in the end-HMPo2 group and 12.9 (4-29.2) hours in the SCS group; median (range) duration in the end-HMPo2 group was 4.7 (0.8-17.1) hours. One-year graft survival was 92.1% (n = 117) in the end-HMPo2 group vs 93.3% (n = 126) in the SCS group (95% CI, -7.5 to 5.1; P = .71). The secondary end point analysis showed no significant between-group differences for delayed graft function, primary nonfunction, estimated glomerular filtration rate, and acute rejection | ||
| 520 | |a Conclusions and Relevance: Reconditioning of expanded criteria donor kidneys from donors who are brain dead using end-HMPo2 after SCS does not improve graft survival or function compared with SCS alone. This study is underpowered owing to the high overall graft survival rate, limiting interpretation | ||
| 520 | |a Trial Registration: isrctn.org Identifier: ISRCTN63852508 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 700 | 1 | |a Boffa, Catherine |e verfasserin |4 aut | |
| 700 | 1 | |a Jochmans, Ina |e verfasserin |4 aut | |
| 700 | 1 | |a Krikke, Christina |e verfasserin |4 aut | |
| 700 | 1 | |a Davies, Lucy |e verfasserin |4 aut | |
| 700 | 1 | |a Mazilescu, Laura |e verfasserin |4 aut | |
| 700 | 1 | |a Brat, Aukje |e verfasserin |4 aut | |
| 700 | 1 | |a Knight, Simon |e verfasserin |4 aut | |
| 700 | 1 | |a Wettstein, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Cseprekal, Orsolya |e verfasserin |4 aut | |
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| 700 | 1 | |a Bellini, Maria Irene |e verfasserin |4 aut | |
| 700 | 1 | |a Szabo, Laszlo |e verfasserin |4 aut | |
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| 700 | 1 | |a Quiroga, Isabel |e verfasserin |4 aut | |
| 700 | 1 | |a Mourad, Michel |e verfasserin |4 aut | |
| 700 | 1 | |a Pratschke, Johann |e verfasserin |4 aut | |
| 700 | 1 | |a Papalois, Vassilios |e verfasserin |4 aut | |
| 700 | 1 | |a Mathe, Zoltan |e verfasserin |4 aut | |
| 700 | 1 | |a Leuvenink, Henri G D |e verfasserin |4 aut | |
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