Hydrocortisone plus fludrocortisone for high-risk heart surgery patients
Official title: Hydrocortisone Plus Fludrocortisone in High-risk Patients Undergoing for Cardiac Surgery
Run by Centre Hospitalier Universitaire, Amiens · NCT07037043 · Data updated 2026-11-12
This trial tests whether adding hydrocortisone and fludrocortisone helps high-risk adults undergoing planned cardiac surgery see if inflammation-related complications improve.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 196 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | April 30, 2025 |
| Main results expected | May 2028 |
| Study ends | June 2028 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07037043 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ at intermediate or high risk for cardiac surgery (EuroSCORE II > 4%) undergoing planned CPB-assisted procedures such as CABG or valve surgeries.
✕Probably not a fit
Patients without a significant inflammatory dysregulation or those with exclusion criteria (e.g., autoimmune disease, chronic steroid use, end-stage renal disease) may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In patients aged 18 or older with intermediate to high surgical risk undergoing planned cardiac procedures and on cardiopulmonary bypass, the study tests a regimen of hydrocortisone plus fludrocortisone against a placebo. The goal is to see if the combination moderates the inflammatory response after surgery and reduces organ dysfunction and other adverse outcomes. The design is phase 3 and randomized, with predefined inclusion and exclusion criteria to identify eligible participants. The trial is led by Centre Hospitalier Universitaire in Amiens with collaboration from Rouen and Lille universities. Outcomes likely focus on postoperative organ function, vasopressor requirements, and rates of complications.
Why it matters
Potential benefit: If successful, patients could experience fewer inflammatory complications and better organ function after high-risk cardiac surgery.
How similar studies have gone: Previous approaches with glucocorticoids in cardiac surgery have shown mixed results; this study tests a specific hydrocortisone–fludrocortisone combination in a modern phase 3 setting.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
-
CHRU Amiens
Amiens, France Recruiting
Study contacts
- Study coordinator: Christophe Beyls, MD
- Email: Beyls.christophe@chu-amiens.fr
- Phone: (33)3 22 08 78 66
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.