Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency (HORNbILL)

This is an interventional treatment trial for Critical Illness Related Corticosteroids Insufficiency focused on measuring critical illness related corticosteroids insufficiency, hydrocortisone, fludrocortisone, ICU, survival Read More

Inclusion Criteria:

• ≥ 18 years;
• Hospitalized in an intensive care unit;
• SOFA score ≥ 6, for at least 6 consecutive hours;
• Informed written consent from patient or from legally authorized next of kin, or emergency deferred consent;
• Affiliation to a social security system or to a universal health coverage (Couverture Maladie Universelle, CMU).

Exclusion Criteria:

• Any suspected or proven acute adrenal insufficiency (As defined in international guidelines; basal cortisol or peak cortisol <18 μg/dL)
• Known chronic adrenal insufficiency
• Concomitant treatment that inhibits cortisol production
• Sepsis, Septic shock (Singer Jama 2016)
• Active tuberculosis or fungal infection
• Active viral hepatitis or active infection with herpes viruses
• Hypersensitivity or contraindication to hydrocortisone, fludrocortisone or Synacthène® or any of their excipients ( SmPC)
• Patient needing either anti-inflammatory corticosteroids or substitutive hydrocortisone for any reason (Such as those suffering from COVID-19 pneumonia requiring oxygen therapy).
• Current treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30 days
• Diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
• Pregnant or breastfeeding woman
• Moribund patient
• Previously enrolled in this study
• Participation to another interventional study that focuses on CIRCI and/or corticoid drugs and/or that addresses a similar primary endpoint as Hornbill ( ventilator- and vasopressor-free survival )
• Patient under guardianship or tutorship Note: Included patients for whom acute adrenal insufficiency would be detected in the Synacthen ® test performed as part of the research for the diagnosis of CIRCI will not be randomized since they should be treated by corticosteroids.