Rapid Recognition of Corticosteroid Resistant or Sensitive Sepsis

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Beckman Coulter, Inc.; Biothelis; Commissariat A L'energie Atomique; Elice; Institut National de la Santé Et de la Recherche Médicale, France; Lumedix; Université Paris Est Créteil; Université Paris Saclay; Versailles Saint-Quentin-en-Yvelines University
• Treatments: Fludrocortisone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

Criteria

Inclusion Criteria:

• Patient ≥18 years old;

• Admitted to ICU;

• Patient 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 RECORDS specific biomarkers:

1. CIRCI neg

2. Endocan < 2 ng/L

3. GILZ < x (to be defined)

4. CPD pos

5. Transcriptomic SRS2

6. Endotype B;

• Patient who has signed the informed consent whenever he/she is able to consent, if not, patient's representative signed ascent whenever he/she is present at 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.

Exclusion Criteria:

• Pregnant woman;

• Expected death or withdrawal of life-sustaining treatments within 48 hours;

• Previously enrolled in this study.