Rapid Recognition of Corticosteroid Resistant or Sensitive Sepsis

NCT04280497 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2020-04-10

Last updated

2025-10-01

Condition(s) studied

Sepsis

Investigational drug(s) / intervention(s)

Administration procedures

Administration procedures: Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off.

Study 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 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

3-month mortality — Daily up to 3 months
Patient's vital status.
Persistent organ dysfunction — At baseline, 1 month and 3 months
Persistent organ dysfunction (defined as continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors) and with SOFA score ≤6 up to 90 days.

Trial sites (1)

Facility	City	Region	Status
Department of medical and surgical Intensive Care Unit, Raymond Poincaré Hospital - APHP	Garches	Hauts-de-Seine	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04280497 on ClinicalTrials.gov ↗ ← All trials in France