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Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1092
Start Date
2022-02-17
Completion Date
2026-02
Last Updated
2025-04-27
Healthy Volunteers
No
Interventions
Investigational products administration
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.
Placebo administration
Placebos for hydrocortisone and for fludrocortisone, administered in same manner as the active drugs in the interventional arm, for 7 days.
Locations (1)
General Intensive care Unit, Raymond Poincaré Hospital, APHP
Garches, France