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Potassium canrenoate in brain-dead organ donors: a randomised controlled clinical trial protocol (CANREO-PMO)
Lilia Belarif1, Sophie Girerd2,3, Frédéric Jaisser3,4
1Department of Anesthesiology and Critical Care Medicine, CHRU de Nancy, Nancy, France.
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 m2 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 μmol/L), with the estimated GFR according to CKD-EPI (in mL/min/1.73 m2), 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.
Insights
Mineralocorticoid receptor antagonists (MRAs) may protect kidney grafts from ischaemia/reperfusion injuries (IRIs). This study assesses MRA safety and hemodynamic tolerance in brain-dead organ donors, crucial for improving graft survival.
Area of Science:
- Nephrology
- Transplantation immunology
- Critical care medicine
Background:
- Ischaemia/reperfusion injuries (IRIs) negatively impact kidney graft survival, especially from expanded criteria donors.
- Mineralocorticoid receptor antagonists (MRAs) show preclinical promise in mitigating IRI-induced renal dysfunction.
- Limited data exist on MRA safety in brain-dead organ donor populations.
Purpose of the Study:
- To investigate the hemodynamic tolerance of MRAs in brain-dead organ donor patients.
- To evaluate the safety and efficacy of MRAs in preserving kidney graft function post-transplantation.
Main Methods:
- A randomized, controlled, double-blind study (CANREO-PMO) involving brain-dead organ donors.
- Participants receive potassium canrenoate or placebo every 6 hours until organ procurement.
- Primary outcome: hierarchical composite endpoint including cardiocirculatory arrest, procurement impossibility, and vasopressor/fluid administration.
Main Results:
- The study aims to recruit 36 patients.
- Secondary outcomes assess graft recipient outcomes, including graft survival, serum creatinine, and estimated GFR at 3 months, 1, 3, and 10 years post-transplantation.
Conclusions:
- Findings will inform the use of MRAs to improve outcomes for kidney transplant recipients from expanded criteria donors.
- This research addresses a critical gap in understanding MRA safety in organ donors, potentially enhancing graft utilization and patient survival.
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