Rapid Recognition of Corticosteroid Resistant or Sensitive Sepsis
Status:
Recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
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
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