Table 3 Primary and secondary outcomes (intention-to-treat and per-protocol population)
Parameter | Intention-to-treat analysis | Per-protocol analysis | ||||
|---|---|---|---|---|---|---|
Intervention (N = 213) | Placebo (N = 213) | P value | Intervention (N = 203) | Placebo (N = 205) | P value | |
90-day mortality, n (%) | 86 (40.4) | 83 (39.0) | 0.77 | 81 (39.9) | 80 (39.0) | 0.86 |
28-day mortality, n (%) | 79 (37.1) | 77 (36.2) | 0.84 | 74 (36.5) | 74 (36.1) | 0.94 |
ICU mortality, n (%) | 68 (31.9) | 62 (29.1) | 0.53 | 64 (31.5) | 59 (28.8) | 0.55 |
Hospital mortality, n (%) | 75 (35.2) | 71 (33.3) | 0.68 | 70 (34.5) | 68 (33.2) | 0.78 |
Reversal of shock, n (%) | 172 (80.8) | 174 (81.7) | 0.80 | 164 (80.8) | 168 (82.0) | 0.76 |
Time to shock reversal (d) | 3.0 (1.0–4.0) | 2.0 (1.0–3.0) | 0.30 | 3.0 (1.0–4.0) | 2.0 (1.0–3.0) | 0.40 |
72-h Delta SOFA score | 2.0 (− 1.0–5.0) | 2.0 (− 1.0–4.0) | 0.59 | 1.0 (− 1.0–4.0) | 2.0 (− 1.0–4.0) | 0.65 |
ICU-free daysa | 13.0 (0.0–22.0) | 14.0 (0.0–23.0) | 0.67 | 13.0 (0.0–22.0) | 14.0 (0.0–23.0) | 0.23 |
Vasopressor-free daysa | 23.9 (0.0–26.3) | 25.0 (0.0–26.5) | 0.26 | 23.9 (0.0–26.3) | 25.0 (0.0–26.5) | 0.36 |
Ventilator support-free daysa | 17.6 (0.0–25.3) | 19.3 (0.0–26.0) | 0.42 | 17.6 (0.0–25.3) | 19.6 (0.0–25.9) | 0.51 |
LOS in ICU, days | 7.0 (4.0–12.5) | 6.0 (4.0–13.5) | 0.85 | 7.0 (4.0–13.0) | 6.0 (4.0–13.5) | 0.93 |
LOS in hospital, days | 16.0 (9.0–25.0) | 17.0 (9.0–29.0) | 0.35 | 16.0 (9.0–26.0) | 17.0 (10.0–29.0) | 0.26 |