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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether giving two medicines—hydrocortisone and fludrocortisone—can help reduce complications after heart surgery in patients who are at higher risk for problems. Heart surgery can cause inflammation in the body, which sometimes leads to serious issues like kidney problems or organ failure. The researchers think that this combination of medicines might better control the immune response and lower the chance of these complications.

To join the study, patients need to be adults having planned heart surgery involving a heart-lung machine, such as bypass surgery or valve repair, and have a moderate to high risk of complications. People with certain conditions like infections, emergency surgeries, or long-term steroid use won’t be eligible. If you join, you can expect to receive the study medicines during and after surgery under close medical supervision. The goal is to see if this treatment improves recovery and reduces serious side effects after surgery. This study is not yet recruiting participants but is designed to help improve care for patients undergoing complex heart surgeries.

Gender

ALL

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).