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Study identifier: NCT07037043 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Inflammation in Cardiac Surgery  ·  Sponsor: Centre Hospitalier Universitaire, Amiens

PhasePhase 3
Planned participants196
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 tha…

This description comes directly from the study's public registry record.

Talk to the study team

Christophe Beyls, MD  ·  (33)3 22 08 78 66  ·  Beyls.christophe@chu-amiens.fr

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Locations (1)

CHRU AmiensAmiens, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT07037043