Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,092

Participants

Timeline

Start Date

February 17, 2022

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2026

Conditions
Critical Illness Related Corticosteroids Insufficiency
Interventions
DRUG

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."

DRUG

Placebo administration

Placebos for hydrocortisone and for fludrocortisone, administered in same manner as the active drugs in the interventional arm, for 7 days.

Trial Locations (1)

92380

RECRUITING

General Intensive care Unit, Raymond Poincaré Hospital, APHP, Garches

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER