Identifying Corticosteroid Response in Sepsis Patients
A Multicentre Concealed-Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy
This study is testing if a combination of hydrocortisone and fludrocortisone can help sepsis patients in the ICU feel better and recover more effectively than a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Garches, Hauts-de-Seine) |
| Trial ID | NCT04280497 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of hydrocortisone combined with fludrocortisone compared to a placebo in patients with sepsis who are admitted to the intensive care unit. It focuses on patients with different immune response profiles to corticosteroids, assessing outcomes such as mortality and organ dysfunction over a 90-day period. Secondary objectives include monitoring quality of life, organ function, secondary infections, and cognitive function. The study seeks to identify biomarkers that can predict which patients will benefit from corticosteroid treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are admitted to the ICU with proven or suspected infection and meet specific criteria related to sepsis severity.
Not a fit: Patients who do not have a confirmed infection or those who are not admitted to the ICU may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for sepsis patients, improving survival rates and quality of life.
How similar studies have performed: Other studies have explored corticosteroid use in sepsis, but this approach of identifying biomarkers for sensitivity and resistance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Garches, Hauts-de-Seine
- Department of medical and surgical Intensive Care Unit, Raymond Poincaré Hospital - APHP — Garches, Hauts-de-Seine, France (Recruiting)
Study contacts
- Principal investigator: Djillali ANNANE, MD, PhD — Department of medical and surgical Intensive Care Unit, - Raymond Poincaré Hospital - APHP
- Study coordinator: Djillali ANNANE, MD, PhD
- Email: djillali.annane@aphp.fr
- Phone: +33 1 47 10 77 87
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.