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

Recruiting Phase 3 Interventional Study
Inflammation in Cardiac Surgery
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
196 (estimated)
Sponsor
Centre Hospitalier Universitaire, Amiens · Other
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About This Trial
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…
Trial Locations
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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 (aorti…
Contacts

Christophe Beyls, MD

(33)3 22 08 78 66

Beyls.christophe@chu-amiens.fr

CONTACT