Table 2 Primary, secondary endpoints and posthoc analyses
Primary endpoint | Secondary endpoints | Post-hoc analyses |
|---|---|---|
28-day mortality | 90-day mortality Delirium incidence | Effectiveness in groups of predicted risk up to 50%, 50–70%, 70–90%, above 90% will be evaluated |
Number of delirium and coma free-days in 28 days | Effectiveness in diagnosis groups: medical, surgical and trauma patients | |
Duration of mechanical ventilation | Effectiveness per APACHE-II score: <20, 20–25, >25 | |
Incidence of unintended tube or catheter removal | Effectiveness in groups with 1, 2, or more positive CAM-ICU scores | |
Incidence of ICU re-admission | ||
Quality of life measured at time of ICU admission, after 1 and 6 months using SF-12 | ||
Incidence and severity of side effects of prophylactic haloperidol (all patients) |