Table 1 Baseline characteristics (intention-to-treat and per-protocol population)
Characteristics | Intention-to-treat analysis | Per-protocol analysis | ||||
|---|---|---|---|---|---|---|
Intervention (N = 213) | Placebo (N = 213) | P value | Intervention (N = 203) | Placebo (N = 205) | P value | |
Age (y) | 69.0 (60.0–78.0) | 71.0 (61.0–78.0) | 0.24 | 69.0 (60.0–78.0) | 71.0 (62.0–78.5) | 0.13 |
Male, n (%) | 138 (64.8) | 147 (69.0) | 0.35 | 131 (64.5) | 142 (69.3) | 0.31 |
APACHE II | 20.0 (14.5–24.0) | 19.0 (14.0–24.0) | 0.39 | 20.0 (15.0–24.0) | 19.0 (14.0–24.0) | 0.52 |
SOFA | 10.0 (7.0–12.0) | 9.0 (7.0–11.0) | 0.26 | 10.0 (7.0–12.0) | 9.0 (7.0–11.0) | 0.30 |
Locale before ICU admission, Emergency department, n (%) | 87 (40.8) | 73 (34.3) | 0.16 | 82 (40.4) | 67 (32.7) | 0.11 |
At least one comorbidity, n (%) | 146 (68.5) | 153 (71.8) | 0.46 | 138 (68.0) | 149 (72.7) | 0.30 |
 Hypertension | 97 (45.5) | 99 (46.5) | 0.85 | 93 (45.8) | 97 (47.3) | 0.76 |
 COPD | 9 (4.2) | 9 (4.2) | 1.00 | 7 (3.4) | 9 (4.4) | 0.62 |
 CAD | 26 (12.2) | 16 (7.5) | 0.10 | 23 (11.3) | 15 (7.3) | 0.16 |
 DM | 42 (19.7) | 52 (24.4) | 0.24 | 41 (20.2) | 51 (24.9) | 0.26 |
 CRD | 9 (4.2) | 9 (4.2) | 1.00 | 9 (4.4) | 9 (4.4) | 0.98 |
 Malignancy | 32 (15.0) | 41 (19.2) | 0.25 | 29 (14.3) | 40 (19.5) | 0.16 |
Primary site of infection, n (%) | ||||||
 Lung | 59 (27.7) | 72 (33.8) | 0.17 | 56 (27.6) | 68 (33.2) | 0.22 |
 Abdominal cavity | 120 (56.3) | 103 (48.4) | 0.10 | 113 (55.7) | 101 (49.3) | 0.20 |
 Urinary tract | 32 (15.0) | 31 (14.6) | 0.89 | 32 (15.8) | 28 (13.7) | 0.55 |
 Skin and soft tissue | 10 (4.7) | 11 (5.2) | 0.82 | 10 (4.9) | 11 (5.4) | 0.84 |
 Other | 21 (9.9) | 20 (9.4) | 0.87 | 20 (9.9) | 20 (9.8) | 0.97 |