Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency (HORNbILL)
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- STATUS
- Recruiting
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- End date
- Feb 21, 2026
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- participants needed
- 1092
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- sponsor
- Assistance Publique - Hôpitaux de Paris
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.
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 called critical illness related corticosteroids insufficiency (CIRCI) in which body homeostasis is lost owing to insufficient cortisol production or bioactivity in tissues. Recent updates of international guidelines have spelled out the pathophysiology, diagnosis and management of CIRCI. The prevalence of CIRCI varies according to case mix and severity of illness. The combination of hydrocortisone and fludrocortisone improved outcomes in septic shock, a condition often complicated with CIRCI. However, there is insufficient evidence on the efficacy of corticosteroids in patients with CIRCI and without septic shock. The hypothesis of the study is that the hydrocortisone-fludrocortisone association will improve ventilation and vasopressor free survival in ICU patients with Critical illness related Corticosteroid Insufficiency.
Patients with a SOFA score ≥ 6 will be screened for CIRCI. Patients suffering from CIRCI will be randomized to receive hydrocortisone and fludrocortisone or their placebo. Patients without CIRCI will receive standard of care and will be followed up during 90 days (cohort-observational study).
Details
| Condition | Critical Illness Related Corticosteroids Insufficiency |
|---|---|
| Treatment | Placebo Administration, Investigational products administration |
| Clinical Study Identifier | NCT04404400 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Last Modified on | 21 March 2022 |
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