Hydrocortisone Plus Fludrocortisone in High-risk Patients Undergoing for Cardiac Surgery
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 re
| Condition(s) | Inflammation in Cardiac Surgery |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 increa |
| Who can participate | 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 su |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Centre Hospitalier Universitaire, Amiens |
| Locations | Amiens, France |
| Start date | 2025-04-30 |
| NCT ID | NCT07037043 |
| Official listing | https://clinicaltrials.gov/study/NCT07037043 |