Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency
Assistance Publique - Hôpitaux de Paris
1,092 participants
Feb 17, 2022
INTERVENTIONAL
Conditions
Summary
The study aims at assessing the efficacy and the safety of hydrocortisone combined with fludrocortisone compared to placebo in ICU adults with critical illness related corticosteroid insufficiency.
Eligibility
Inclusion Criteria5
- Adult (≥ 18 years);
- Hospitalized in an intensive care unit;
- SOFA score ≥ 4, 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 Criteria17
- Any suspected or proven acute adrenal insufficiency (As defined in international guidelines; basal cortisol \< 5 μg/dL or peak (60) cortisol \<18 μg/dL)
- Expected death or withdrawal of life-sustaining treatments within 48 hours
- Known chronic adrenal insufficiency
- Concomitant treatment that inhibits cortisol production
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Investigational products include: * Hydrocortisone hemisuccinate 50 mg: one intravenous injection every 6 hours, and * 9 alpha fludrocortisone 50 μg: one tablet per day via a nasogastric tube. All treatments will be stopped after 7 days or until the patient has left the intensive care unit (whichever occurs first) without tapering off.
Placebos for hydrocortisone and for fludrocortisone, administered in same manner as the active drugs in the interventional arm, for 7 days.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04404400