Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Criteria

Inclusion Criteria:

• ≥ 18 years;

• Hospitalized in an intensive care unit;

• SOFA score ≥ 6, for at least 6 consecutive hours;

• Informed written consent from patient or from legally authorized next of kin, or emergency deferred consent.

Exclusion Criteria:

• Septic shock;

• Active tuberculosis or fungal infection;

• Active viral hepatitis or active infection with herpes viruses;

• Hypersensitivity to corticosteroids;

• Patient requiring corticosteroids;

• Current treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30 days;

• Pregnant or breastfeeding woman;

• Moribund patient;

• Persons without social security;

• Under guardianship.