{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T12:28:33Z","timestamp":1770985713050,"version":"3.50.1"},"reference-count":46,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2023,10,11]],"date-time":"2023-10-11T00:00:00Z","timestamp":1696982400000},"content-version":"unspecified","delay-in-days":10,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"French Eastern Interregional Group of Clinical Research and Innovation","award":["APJ 2019"],"award-info":[{"award-number":["APJ 2019"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,9,28]]},"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Ischaemia\/reperfusion injuries (IRIs) are associated with poorer survival of kidney grafts from expanded criteria donors. Preclinical studies have shown that mineralocorticoid receptor antagonists (MRAs) prevent acute and chronic post-ischaemic renal dysfunction by limiting IRI. However, data concerning the safety of MRAs in brain-dead donor patients are scarce. We seek to investigate the tolerance of MRAs on the haemodynamics in this population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      CANREO-PMO is a randomised, controlled, single-centre, double-blind study. Brain-dead organ donors hospitalised in intensive care are randomised 1:1 after consent to receive 200\u2009mg potassium canrenoate or its matching placebo every 6\u2009hours until organ procurement. The primary outcome is a hierarchical composite endpoint that includes: (1) cardiocirculatory arrest, (2) the impossibility of kidney procurement, (3) the average hourly dose of norepinephrine\/epinephrine between randomisation and departure to the operating room, and (4) the average hourly volume of crystalloids and\/or colloids received. Thirty-six patients will be included. The secondary endpoints evaluated among the graft recipients are the: (1) vital status of the kidney graft recipients and serum creatinine level with estimated glomerular filtration rate (GFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) at 3\u2009months after renal transplantation, (2) percentage of patients dependent on dialysis and\/or with an estimated GFR &lt;20\u2009mL\/min\/1.73\u2009m\n                      <jats:sup>2<\/jats:sup>\n                      at 3\u2009months, (3) vital status of the kidney graft recipients at 3\u2009months, and (4) vital status of the kidney graft recipients and creatinine levels (in \u03bcmol\/L), with the estimated GFR according to CKD-EPI (in mL\/min\/1.73\u2009m\n                      <jats:sup>2<\/jats:sup>\n                      ), at 1\u2009year, 3\u2009years and 10 years after transplantation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This trial has full ethical approval (Comit\u00e9 de Protection des Personnes: CPP Ouest II-ANGERS, France), and the written consent of relatives will be obtained. Results will be reported at conferences, peer-reviewed publications and using social media channels.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04714710\">NCT04714710<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-073831","type":"journal-article","created":{"date-parts":[[2023,10,11]],"date-time":"2023-10-11T12:18:02Z","timestamp":1697026682000},"page":"e073831","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Potassium canrenoate in brain-dead organ donors: a randomised controlled clinical trial protocol (CANREO-PMO)"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct04714710","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02490904","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04714710","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02490904","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6531-1868","authenticated-orcid":false,"given":"Lilia","family":"Belarif","sequence":"first","affiliation":[{"name":"Department of Anesthesiology and Critical Care Medicine, CHRU de Nancy, Nancy, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sophie","family":"Girerd","sequence":"additional","affiliation":[{"name":"Department of Nephrology, CHRU de Nancy, Nancy, France"},{"name":"Centre d'Investigations Cliniques-Plurith\u00e9matique 1433 (CIC-P), INI-CRCT-Cardiovascular and Renal Clinical Trialists, CHRU de Nancy, Nancy, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fr\u00e9d\u00e9ric","family":"Jaisser","sequence":"additional","affiliation":[{"name":"Centre d'Investigations Cliniques-Plurith\u00e9matique 1433 (CIC-P), INI-CRCT-Cardiovascular and Renal Clinical Trialists, CHRU de Nancy, Nancy, France"},{"name":"INSERM UMRS 1138, Centre de Recherche des Cordeliers, Sorbonne Universite, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xavier","family":"Lepage","sequence":"additional","affiliation":[{"name":"Centre d'Investigations Cliniques-Plurith\u00e9matique 1433 (CIC-P), INI-CRCT-Cardiovascular and Renal Clinical Trialists, CHRU de Nancy, Nancy, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ludovic","family":"Merckle","sequence":"additional","affiliation":[{"name":"Centre d'Investigations Cliniques-Plurith\u00e9matique 1433 (CIC-P), INI-CRCT-Cardiovascular and Renal Clinical Trialists, CHRU de Nancy, Nancy, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin","family":"Duarte","sequence":"additional","affiliation":[{"name":"Centre d'Investigations Cliniques-Plurith\u00e9matique 1433 (CIC-P), INI-CRCT-Cardiovascular and Renal Clinical Trialists, CHRU de Nancy, Nancy, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicolas","family":"Girerd","sequence":"additional","affiliation":[{"name":"Centre d'Investigations Cliniques-Plurith\u00e9matique 1433 (CIC-P), INI-CRCT-Cardiovascular and Renal Clinical Trialists, CHRU de Nancy, Nancy, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4664-1861","authenticated-orcid":false,"given":"Philippe","family":"Guerci","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Critical Care Medicine, CHRU de Nancy, Nancy, France"},{"name":"INSERM U1116, DCAC, University of Lorraine, Nancy, France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2023,10,11]]},"reference":[{"key":"2025121411145601000_13.10.e073831.1","unstructured":"Agence de la Biom\u00e9decine-Agence de la Biom\u00e9decine - le rapport Annuel M\u00e9dical et Scientifique. 2019. 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