NCT07037043 Hydrocortisone Plus Fludrocortisone in High-risk Patients Undergoing for Cardiac Surgery

Eligibility & Interventions

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You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 196 participants in total. It began in 2025-04-30 with a primary completion date of 2028-05.

Brief Summary

Cardiac surgery is a high-risk surgery and is associated with a rate of postoperative adverse outcomes. Like many others major surgery, cardiac surgery procedures induce a proinflammatory phase usually counterbalanced with an immunosuppressive phase so the immune response remained balanced. In some cases, the immune response might be dysregulated with a more pronounced pro inflammatory state that compromises organ perfusion and with the occurrence of organ failure. From a mechanistic approach, the relationship between organ failure is complex and multifactorial with a high level of proinflammatory cytokines, a decrease in microcirculation, an endothelial dysfunction and an activation of coagulation and over. The clinical expression is an increase in vasopressor exposure and dose, an increase in mortality and in adverse outcomes with a predominance of acute kidney injury. Various therapies have been assessed to manage cardiac surgery related sepsis including glucocorticoid therapy. Briefly, two major randomized trials assessed glucocorticoid therapy solely in scheduled cardiac surgery with cardiopulmonary bypass. No clinical benefit was demonstrated in term of reduction in postoperative mortality or adverse outcomes. Since, data support that the selection of patients at risk is crucial to demonstrate such a strategy. Indeed, data support that surprisingly some patients will have a very light immune response reflected by a low pro inflammatory cytokine. The hypothesis is that the combination glucocorticoid and fludrocortisone could decrease adverse outcomes in selected patients.

Eligibility Criteria

Inclusion Criteria: * Age \> 18 years. * Patient at intermediate/high risk (EuroSCORE II \> 4%). * Patient admitted for scheduled cardiac surgery: * Coronary artery bypass grafting (CABG). * Aortic valve replacement. * Mitral valve repair or replacement. * Surgery of the aortic root (aortic tube, Bentall procedure, Tirone David procedure, or other). * Combined surgery. * Patient undergoing cardiopulmonary bypass (CPB). * Informed consent signed by the patient. Exclusion Criteria: * Endocarditis * Off-pump heart surgery * Heart transplantation or long-term ventricular assist device (VAD) * Emergency surgery: aortic dissection, emergency coronary artery bypass grafting (CABG) * Failure to wean from CPB requiring short-term mechanical support (intra-aortic balloon pump, ECMO) * Hypothermic surgery * History of cardiac surgery * Patient on long-term corticosteroid therapy * Autoimmune disease or chronic inflammatory condition * End-stage renal disease on long-term dialysis * Contraindications to the administration of hydrocortisone and/or fludrocortisone according to the summary of product characteristics (SmPC) * Pregnant or breastfeeding woman * Patient under legal protection (guardianship, curators, or judicial safeguard).

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