Actively Recruiting
Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-27
1092
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (18 years or older)
- Hospitalized in an intensive care unit
- SOFA score of 4 or higher for at least 6 consecutive hours
- Informed written consent from patient, legally authorized representative, or emergency deferred consent
- Affiliated with a social security system or universal health coverage
You will not qualify if you...
- Suspected or proven acute adrenal insufficiency (basal cortisol < 5 mcg/dL or peak cortisol <18 mcg/dL)
- Expected death or decision to withdraw life-sustaining treatments within 48 hours
- Known chronic adrenal insufficiency
- Taking medications that inhibit cortisol production
- Septic shock diagnosis
- Active tuberculosis or fungal infection
- Active viral hepatitis or herpes virus infection
- Allergy or contraindication to hydrocortisone, fludrocortisone, Synacthène®, or their ingredients
- Need for corticosteroids for other reasons such as COVID-19 pneumonia requiring oxygen
- Current treatment with more than 15 mg/day prednisone or equivalent for over 30 days
- Diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
- Pregnant or breastfeeding
- Moribund condition
- Previous participation in this study
- Participation in another interventional study focusing on CIRCI, corticosteroids, or similar endpoints
- Under guardianship or tutorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
General Intensive care Unit, Raymond Poincaré Hospital, APHP
Garches, France, 92380
Actively Recruiting
Research Team
N
Nicholas HEMING, MD, PhD
CONTACT
D
Djillali ANNANE, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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