Informations générales (source: ClinicalTrials.gov)
A Multicentre Concealed-Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
avril 2020
mai 2025
12 septembre 2025
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 mechanical ventilation, new renal replacement therapy,
or vasopressors - assessed at 90 days on intensive care unit (ICU) adults and having
different biological profiles for immune responses and corticosteroids bioactivity.
Secondary objectives and endpoints:
- Mortality and health-related quality of life at 6 months;
- Daily organ function (SOFA score days 1, 2, 3, 4, 7, 10, 14, 28, and 90);
- Daily secondary infections (up to 90 days)
- Daily blood and urinary levels of glucose, sodium and potassium (up to 28 day)
- Daily gastroduodenal bleeding (up to 28 day)
- Daily cognitive function and muscles' strength (days 1 to 28, 90 and 180 days).
Etablissements
Critères
Tous
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.
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.
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