NCT04404400 Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency
| NCT ID | NCT04404400 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Critical Illness Related Corticosteroids Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,092 participants |
| Start Date | 2022-02-17 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,092 participants in total. It began in 2022-02-17 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Adult (≥ 18 years); * Hospitalized in an intensive care unit; * SOFA score ≥ 4, for at least 6 consecutive hours; * Informed written consent from patient or from legally authorized next of kin, or emergency deferred consent; * Affiliation to a social security system or to a universal health coverage (Couverture Maladie Universelle, CMU). Exclusion Criteria: * Any suspected or proven acute adrenal insufficiency (As defined in international guidelines; basal cortisol \< 5 μg/dL or peak (60) cortisol \<18 μg/dL) * Expected death or withdrawal of life-sustaining treatments within 48 hours * Known chronic adrenal insufficiency * Concomitant treatment that inhibits cortisol production * Septic shock (Singer Jama 2016) * Active tuberculosis or fungal infection * Active viral hepatitis or active infection with herpes viruses * Hypersensitivity or contraindication to hydrocortisone, fludrocortisone or Synacthène® or any of their excipients ( SmPC) * Patient needing either anti-inflammatory corticosteroids or substitutive hydrocortisone for any reason (Such as those suffering from COVID-19 pneumonia requiring oxygen therapy). * Current treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30 days * Diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome * Pregnant or breastfeeding woman * Moribund patient * Previously enrolled in this study * Participation to another interventional study that focuses on CIRCI and/or corticoid drugs and/or that addresses a similar primary endpoint as Hornbill ( ventilator- and vasopressor-free survival ) * Patient under guardianship or tutorship Note: Included patients for whom acute adrenal insufficiency would be detected in the Synacthen ® test performed as part of the research for the diagnosis of CIRCI will not be randomized since they should be treated by corticosteroids.
Contact & Investigator
Nicholas HEMING, MD, PhD
PRINCIPAL INVESTIGATOR
General Intensive care Unit, Raymond Poincaré Hospital, APHP
Frequently Asked Questions
Who can join the NCT04404400 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness Related Corticosteroids Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04404400 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,092 participants.
Is NCT04404400 currently recruiting?
Yes, NCT04404400 is actively recruiting participants. Contact the research team at nicholas.heming@aphp.fr for enrollment information.
Where is the NCT04404400 trial being conducted?
This trial is being conducted at Garches, France.
Who is sponsoring the NCT04404400 clinical trial?
NCT04404400 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Nicholas HEMING, MD, PhD at General Intensive care Unit, Raymond Poincaré Hospital, APHP. The trial plans to enroll 1,092 participants.