Could a steroid combo be the key to fighting sepsis? large trial seeks answers
NCT ID NCT04280497
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a combination of two steroids (hydrocortisone and fludrocortisone) can reduce death or long-term organ failure in adults with sepsis in the ICU. About 1,800 participants will receive either the steroid combo or a placebo, and researchers will track their health for up to 6 months. The goal is to find out which sepsis patients benefit most from this treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2020
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient ≥18 years old; 2. Admitted to ICU with proven or suspected infection as the main diagnosis; 3. Community acquired pneumonia related sepsis or vasopressors dependency (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine) or septic shock (vasopressor to maintain mean blood pressure of at least 65 mmHg and lactate levels above 2 mmol/l) or acute respiratory distress syndrome (ARDS: a- acute onset, i.e. within one week of an apparent clinical insult and with progression of respiratory syndrome, b- bilateral opacities on chest imaging not explained by other pulmonary pathologies, e.g. pleural effusion, atelectasis, nodules etc, c- no evidence for heart failure or volume overload, d- PaO2/FiO2 ≤ 300 mm Hg, - PEEP ≥ 5 cm H2O; 4. Patients who have been tested for one or more RECORDS specific biomarkers: 1. CIRCI 2. Endocan 3. GILZ 4. DUSP-1 5. MDW 6. lymphopenia 7. Transcriptomic SRS2 8. Endotype B 9. PCR COVID-19 10. PCR Influenza 11. PCR other respiratory virus 12. Cutaneous vasoconstrictor response to glucocorticoids 5. Patient who has signed an informed and written consent whevener he/she is able of consent, if not, if not ascent from his/her representant whenever he/she is present at time of screening for inclusion; 6. Patient affiliated to a social security system or to an universal health coverage (Couverture Maladie Universelle (CMU) in France; 7. Patient under guardianship or curatorship will be included; 8. Patient in case of simple emergency (legal definition) will be included; 9. Patients managed with covid 19 and having biological samples available. Exclusion Criteria: 1. Pregnancy; 2. Expected death or withdrawal of life-sustaining treatments within 48 hours; 3. Previously enrolled in this study 4. Formal indication for corticosteroids according to most recent international guidelines 5. Vaccination with live virus within past 6 months 6. Hypersensitivity to hydrocortisone or fludrocortisone or (microsined betamethasone dipropionate\*) or any of their excipients (spc) 7. Women of childbearing potential not using contraception 8. Nursing women \* For patients included in this stratum, if applicable, do not apply the cream to an infected or ulcerated area
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of medical and surgical Intensive Care Unit, Raymond Poincaré Hospital - APHP
RECRUITINGGarches, Hauts-de-Seine, 92380, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can warming the body help sepsis patients who cannot make a fever?
- Can a simple ultrasound measurement reveal heart strain in sepsis?
- Clotting clues: simple blood test eyed to catch sepsis before it turns deadly
- Can two blood markers catch sepsis before it turns deadly?
- Two cheap blood ratios put to the test as sepsis death predictors
- Can a computer model speed up sepsis blood tests?