Table 3.
Primary and Secondary Efficacy End Points.*
| End Point | Dexmedetomidine (N = 214) | Propofol (N =208) |
|---|---|---|
| Primary end point | ||
| Days alive without delirium or coma at 14 days | ||
| Unadjusted no. of days — median (IQR) | 8.0 (1.0–12.8) | 7.5 (1.8–11.2) |
| Adjusted no. of days — median (95% CI) | 10.7 (8.5–12.5) | 10.8 (8.7–12.6) |
| Adjusted odds ratio (95% CI) | 0.96 (0.74–1.26) | Reference |
| Secondary end points | ||
| Ventilator-free days at 28 days | ||
| Unadjusted no. of days — median (IQR) | 20.9 (0.0–26.1) | 19.9 (4.2–24.9) |
| Adjusted no. days — median (95% CI) | 23.7 (20.5–25.4) | 24.0 (20.9–25.4) |
| Adjusted odds ratio (95% CI) | 0.98 (0.63–1.51) | Reference |
| Death at 90 days | ||
| Unadjusted no. of patients (%) | 81 (38) | 82 (39) |
| Adjusted hazard ratio (95% CI) | 1.06 (0.74–1.52) | Reference |
| TICS-T score at 6 mo† | ||
| Unadjusted score — median (IQR) | 39 (28–48) | 38 (30–46) |
| Adjusted score — median (95% CI) | 40.9 (33.6–47.1) | 41.4 (34.0–47.3) |
| Adjusted odds ratio (95% CI) | 0.94 (0.66–1.33) | Reference |
Variables in adjusted analyses, except for analysis of death at 90 days, included the following: age at trial enrollment; education; baseline cognitive function as determined according to the IQCODE-SF; preexisting coexisting conditions according to the Charlson Comorbidities Index; SOFA assessment on the day of enrollment (excluding central nervous system component); level of arousal at randomization according to the RASS score closest to the time of randomization; exposure to propofol, dexmedetomidine, benzodiazepines, opioids, and antipsychotics between the time of ICU admission and midnight before enrollment; medical (vs. surgical) patient; and infection type. Variables in adjusted analyses for death at 90 days included the following: age at trial enrollment, baseline cognitive function as determined according to the IQCODE-SF, preexisting coexisting conditions according to the Charlson Comorbidities Index, SOFA assessment on the day of enrollment (excluding central nervous system component), medical (vs. surgical) patient, and infection type.
Age-adjusted total scores on the Telephone Interview for Cognitive Status questionnaire (TICS-T) range from 0 to 100 with a mean of 50±10; lower scores indicate worse cognition, and a score of 35 or less indicates cognitive impairment.