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Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency
EU CTIS ID: 2024-516021-32-00
What this study is testing
To assess the efficacy on ventilator- and vasopressor-free days within 30 days (deaths assigned zero days) post randomization of hydrocortisone combined with fludrocortisone compared to placebo in ICU adults with critical illness related corticosteroid insufficiency.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult (≥18 years)
- Hospitalized in an intensive care unit
- SOFA score (SOFA; Sequential Organ Failure Assessment) ≥4, for at least 6 consecutive hours
- Informed written consent from patient or from legally authorized trusted person or next of kin, if present at time of inclusion. When a patient is unable to be informed, and no legally authorized trusted person or next of kin is present, the patient may still be included (emergency procedure), and patient’s, or, where appropriate, the legally authorized trusted person or next of kin’s, deferred consent needs to be obtained as soon as possible (Article L1122-1-3; Public Health Code).
- Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU)
You likely can't join if
- Any suspected or proven acute adrenal insufficiency (As defined in international guidelines; basal cortisol < 5 μg/dl or peak (T60) cortisol <18 μg/dL)
- Current treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30days
- Diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
- Pregnant or breastfeeding woman
- Moribund patient
- Previously enrolled in this study
See the full eligibility criteria
- Adult (≥18 years)
- Hospitalized in an intensive care unit
- SOFA score (SOFA; Sequential Organ Failure Assessment) ≥4, for at least 6 consecutive hours
- Informed written consent from patient or from legally authorized trusted person or next of kin, if present at time of inclusion. When a patient is unable to be informed, and no legally authorized trusted person or next of kin is present, the patient may still be included (emergency procedure), and patient’s, or, where appropriate, the legally authorized trusted person or next of kin’s, deferred consent needs to be obtained as soon as possible (Article L1122-1-3; Public Health Code).
- Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU)
- Any suspected or proven acute adrenal insufficiency (As defined in international guidelines; basal cortisol < 5 μg/dl or peak (T60) cortisol <18 μg/dL)
- Current treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30days
- 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 adresses a similar primary endpoint as Hornbill (survival or use of vasopressors or of mechanical ventilation)
- 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.
- 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 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.