Study of Hydrocortisone and Fludrocortisone to Reduce Complications in Adults Having High-Risk Cardiac Surgery with Cardiopulmonary Bypass

What this Trial Is About

Researchers are evaluating the use of combined hydrocortisone and fludrocortisone therapy in patients at intermediate to high risk undergoing scheduled cardiac surgery with cardiopulmonary bypass. Cardiac surgery can trigger a complex immune response that sometimes becomes unbalanced, leading to organ failure and increased complications such as acute kidney injury. Previous studies on glucocorticoid therapy alone showed no clear benefit, so this study aims to assess whether the combination of hydrocortisone and fludrocortisone can reduce adverse outcomes in selected patients. Participants will be randomly assigned to receive either hydrocortisone 200 mg per day intravenously for 5 days or until ICU discharge, starting at the beginning of cardiopulmonary bypass, along with fludrocortisone 50 micrograms daily administered orally or via nasogastric tube. The control group will receive placebos matching the administration schedule of both drugs. This double-blind treatment period lasts up to 5 days or until ICU discharge. During the study, patients will be closely monitored for the occurrence of acute kidney injury, postoperative pulmonary complications, and norepinephrine requirements within 7 days after surgery. Additional assessments include rates of atrial fibrillation, myocardial infarction, stroke, glucocorticoid side effects, and mortality at 28 days. The research team will evaluate these outcomes to understand the therapys impact and ensure patient safety throughout the trial, which will continue until June 2028.

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