Status:
RECRUITING
Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Critical Illness Related Corticosteroids Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
The hypothalamic-pituitary-adrenal axis together with the noradrenergic/vasopressinergic system are the main systems of host response to stress. In 2008 the scientific community described a syndrome c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
1092 Patients enrolled
Trial Details
Trial ID
NCT04404400
Start Date
February 17 2022
End Date
February 1 2026
Last Update
April 27 2025
Active Locations (1)
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1
General Intensive care Unit, Raymond Poincaré Hospital, APHP
Garches, France, 92380