Critically ill patients who are dependent on high level medical care including mechanical ventilation, vasopressors and sedative/analgesic medication
Conditions
Brief summary
The study primary outcome is 90-day all-cause mortality.
Detailed description
• Number of days alive and free of coma and delirium at 28 days, • Number of days alive and ventilator free at 28 days, • Major Adverse Kidney Events at 28 days (Mortality + Acute Kidney Injury > stage II, defined by Kidney Disease Improving Global Outcome (KDIGO) definition, • Duration of mechanical ventilation in survivors, • Hospital length of stay in survivors
Interventions
DRUGPlacebo is 2 ml of saline manufactured by EVER Pharma according to the same GMP manufacturing certificate
DRUGDexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution for infusion
Sponsors
Monash University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study primary outcome is 90-day all-cause mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number of days alive and free of coma and delirium at 28 days, • Number of days alive and ventilator free at 28 days, • Major Adverse Kidney Events at 28 days (Mortality + Acute Kidney Injury > stage II, defined by Kidney Disease Improving Global Outcome (KDIGO) definition, • Duration of mechanical ventilation in survivors, • Hospital length of stay in survivors | — |
Countries
Finland, Germany, Ireland, Netherlands
Outcome results
None listed