RecruitingPhase 3NCT04404400

Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

1,092 participants

Start Date

Feb 17, 2022

Study Type

INTERVENTIONAL

Conditions

Critical Illness Related Corticosteroids Insufficiency

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Investigational products administration and a drug called Placebo administration for people with critical illness related corticosteroids insufficiency. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInvestigational 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.

DRUGPlacebo 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

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NCT04404400