Status:
RECRUITING
Rapid Recognition of Corticosteroid Resistant or Sensitive Sepsis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Versailles Saint-Quentin-en-Yvelines University
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Main objective and primary endpoint: To compare the effect hydrocortisone plus fludrocortisone vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on ...
Detailed Description
The potential benefits of a lower dose ( ≤ 400 mg of hydrocortisone or equivalent per day), and a longer duration at full dose ( ≥ three days) of treatment, have been investigated in numerous randomiz...
Eligibility Criteria
Inclusion
- Patient ≥18 years old;
- Admitted to ICU with proven or suspected infection as the main diagnosis;
- 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;
- Patients who have been tested for one or more RECORDS specific biomarkers:
- CIRCI
- Endocan
- GILZ
- DUSP-1
- MDW
- lymphopenia
- Transcriptomic SRS2
- Endotype B
- PCR COVID-19
- PCR Influenza
- PCR other respiratory virus
- Cutaneous vasoconstrictor response to glucocorticoids
- 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;
- Patient affiliated to a social security system or to an universal health coverage (Couverture Maladie Universelle (CMU) in France;
- Patient under guardianship or curatorship will be included;
- Patient in case of simple emergency (legal definition) will be included;
- Patients managed with covid 19 and having biological samples available.
Exclusion
- Pregnancy;
- Expected death or withdrawal of life-sustaining treatments within 48 hours;
- Previously enrolled in this study
- Formal indication for corticosteroids according to most recent international guidelines
- Vaccination with live virus within past 6 months
- Hypersensitivity to hydrocortisone or fludrocortisone or (microsined betamethasone dipropionate\*) or any of their excipients (spc)
- Women of childbearing potential not using contraception
- Nursing women \* For patients included in this stratum, if applicable, do not apply the cream to an infected or ulcerated area
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT04280497
Start Date
April 10 2020
End Date
December 1 2025
Last Update
October 1 2025
Active Locations (1)
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1
Department of medical and surgical Intensive Care Unit, Raymond Poincaré Hospital - APHP
Garches, Hauts-de-Seine, France, 92380