Hydrocortisone Plus Fludrocortisone in High-risk Patients Undergoing for Cardiac Surgery
Status:
NOT_YET_RECRUITING
Trial end date:
2028-06-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE3
Details
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Collaborators:
University Hospital, Lille University Hospital, Rouen