Research Article: Potassium canrenoate in brain-dead organ donors: a randomised controlled clinical trial protocol (CANREO-PMO)
Abstract:
Introduction 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. Methods and analysis 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?mg potassium canrenoate or its matching placebo every 6?hours 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?months after renal transplantation, (2) percentage of patients dependent on dialysis and/or with an estimated GFR <20?mL/min/1.73?m 2 at 3?months, (3) vital status of the kidney graft recipients at 3?months, and (4) vital status of the kidney graft recipients and creatinine levels (in ?mol/L), with the estimated GFR according to CKD-EPI (in mL/min/1.73?m 2 ), at 1?year, 3?years and 10 years after transplantation. Ethics and dissemination This trial has full ethical approval (Comité 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. Trial registration number NCT04714710 .
Introduction:
The kidney is the most frequently transplanted organ worldwide. In France, 17?277 patients were on the waiting list in 2021 and only 3252 transplantations were performed. This organ shortage has an adverse impact on the survival of patients with chronic kidney disease. To improve access to transplantation, an increasing proportion of grafts have come from donors with expanded criteria. Expanded criteria donors (ECDs) are defined as donors who are brain dead and aged >60 years or from 50 to 59 years with two of…
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