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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

June 30, 2028

Conditions
Inflammation in Cardiac Surgery
Interventions
DRUG

hydrocortisone plus fludrocortisone

"* Hydrocortisone 200 mg/day for 5 days or until ICU discharge, starting at the initiation of cardiopulmonary bypass (CPB), administered intravenously via syringe pump in a double-blind manner~* Fludrocortisone 50 µg/day in the morning for 5 days or until ICU discharge, administered orally or via nasogastric tube (if the patient is sedated), diluted in a glass of water, in a double-blind manner"

DRUG

placebo of hydrocortisone plus fludrocortisone

"* Placebo for hydrocortisone (0.9% NaCl) administered following the same protocol as fludrocortisone in the intervention group~* Placebo for fludrocortisone (capsule containing microcrystalline cellulose diluted in a glass of water) administered following the same protocol as fludrocortisone in the intervention group"

Trial Locations (1)

80480

CHRU Amiens, Amiens

All Listed Sponsors
collaborator

University Hospital, Rouen

OTHER

collaborator

University Hospital, Lille

OTHER

lead

Centre Hospitalier Universitaire, Amiens

OTHER