Sepsis
Conditions
Brief summary
Dual primary endpoints will be 1/ 28-day all-cause mortality 2/ Number of days alive without life-supportive therapies (respiratory support: high flow oxygen, non-invasive or invasive mechanical ventilation, extracorporeal membrane oxygenation or CO2 removal; cardiovascular support: continuous infusion of any dose of vasopressor or inotrope, or mechanical circulatory assistance; renal support: intermittent or continuous renal replacement therapy) at day 28 after randomization
Detailed description
Composite and hierarchised of the 2 dual primary outcomes, using a Generalized Pairwise Comparison (GPC) for Prioritized Outcomes,, 90-day, 1-year, and 3-year survival, 1- and 3-years hospital free days, Time to recover walking without aid, Time to resume previous social and professional activities, Quality of life at 90-day, 1-year, and 3-year using, in adults, SF-36, and 5-level EQ-5D version (EQ-5D-5L), and in children the Functional Status Scale (FSS) and the PedsQL.
Interventions
DRUGHYDROCORTISONE
DRUGANAKINRA
DRUGTOCILIZUMAB
DRUGOCTAPLASLG
DRUGsolution pour perfusion
DRUGINTERFERON GAMMA
DRUGBARICITINIB
DRUGHEPARIN
DRUGDALTEPARIN
DRUGFLUDROCORTISONE
DRUGFILGRASTIM
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dual primary endpoints will be 1/ 28-day all-cause mortality 2/ Number of days alive without life-supportive therapies (respiratory support: high flow oxygen, non-invasive or invasive mechanical ventilation, extracorporeal membrane oxygenation or CO2 removal; cardiovascular support: continuous infusion of any dose of vasopressor or inotrope, or mechanical circulatory assistance; renal support: intermittent or continuous renal replacement therapy) at day 28 after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite and hierarchised of the 2 dual primary outcomes, using a Generalized Pairwise Comparison (GPC) for Prioritized Outcomes,, 90-day, 1-year, and 3-year survival, 1- and 3-years hospital free days, Time to recover walking without aid, Time to resume previous social and professional activities, Quality of life at 90-day, 1-year, and 3-year using, in adults, SF-36, and 5-level EQ-5D version (EQ-5D-5L), and in children the Functional Status Scale (FSS) and the PedsQL. | — |
Countries
France
Outcome results
None listed