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RECRUITING
NCT04404400
PHASE3

Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

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.

Locations (1)

General Intensive care Unit, Raymond Poincaré Hospital, APHP

Garches, France