Table 2 Baseline clinical and laboratory parameters (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 | |
Leucocytes (× 109/L) | 11.1 (4.9–17.4) | 12.3 (6.5–17.0) | 0.41 | 11.1 (4.9–17.4) | 12.3 (6.6–17.0) | 0.45 |
Platelets (× 109/L) | 135.0 (82.0–197.5) | 143.0 (90.5–223.5) | 0.10 | 135.0 (83.0–198.0) | 143.0 (90.5–223.5) | 0.14 |
PT (s) | 15.3 (13.7–17.8) | 15.5 (14.2–18.1) | 0.08 | 15.3 (13.7–17.9) | 15.5 (14.1–18.3) | 0.10 |
PH | 7.3 (7.3–7.4) | 7.4 (7.3–7.4) | 0.38 | 7.4 (7.3–7.4) | 7.4 (7.3–7.4) | 0.52 |
PaO2/FiO2 (mmHg) | 240.8 (179. 5–359.5) | 225.0 (159.6–344.4) | 0.24 | 240.8 (174.0–361.0) | 225.0 (159.1–344.4) | 0.26 |
Lactate (mmol/L) | 3.1 (2.3–4.4) | 2.9 (2.2–4.3) | 0.43 | 3.1 (2.3–4.4) | 3.0 (2.2–4.4) | 0.70 |
Total bilirubin (μmol/L) | 17.9 (12.9–32.6) | 21.9 (14.7–33.4) | 0.13 | 17.6 (12.8–32.1) | 21.9 (14.9–33.4) | 0.07 |
Creatinine (μmol/L) | 117.7 (73.0–223.5) | 118.0 (76.7–209.4) | 0.69 | 118.5 (73.0–223.5) | 120.0 (76.9–211.3) | 0.70 |
Bacteremia, n (%) | 79 (37.1) | 62 (29.1) | 0.08 | 75 (36.9) | 60 (29.3) | 0.10 |
LOS prior to randomization (d) | 0.4 (0.3–1.4) | 0.5 (0.3–3.5) | 0.11 | 0.4 (0.3–1.6) | 0.6 (0.3–3.6) | 0.12 |
Time from diagnosis to randomization (h) | 2.0 (0.0–6.0) | 1.5 (0.0–6.3) | 0.85 | 2.0 (0.0–6.0) | 1.8 (0.0–6.5) | 0.88 |
Time from randomization to first study drug (h) | 1.0 (0.0–3.0) | 1.0 (1.0–3.0) | 0.11 | 1.0 (0.0–3.0) | 1.0 (1.0–3.0) | 0.11 |
Time from randomization to first antibiotic (h) | 2.0 (1.0–3.0) | 2.0 (1.0–3.0) | 0.45 | 2.0 (1.0–3.0) | 2.0 (1.0–3.0) | 0.54 |
Antibiotic before randomization, n (%) | 134 (62.9) | 141 (66.2) | 0.48 | 130 (64.0) | 134 (65.4) | 0.84 |
Appropriateness of antimicrobials, n (%) | 108 (50.7) | 101 (47.4) | 0.50 | 96 (47.3) | 108 (52.7) | 0.28 |
Open-label hydrocortisone: Additional steroidsa | 5:6 | 4:10 | 0.56c | 5:4 | 4:9 | 0.35c |
Amount of fluid administered before vasopressor (L) | 0.8 (0.6–1.2) | 0.7 (0.5–1.3) | 0.56 | 0.8 (0.6–1.2) | 0.7 (0.5–1.3) | 0.71 |
Need for ventilator supportb, n (%) | 175 (82.2) | 185 (86.9) | 0.18 | 168 (82.8) | 179 (87.3) | 0.20 |
IMV: HFNC: NIVb | 143:21:11 | 158:19:8 | 0.42 | 138:21:9 | 154:17:8 | 0.45 |
Need for RRTb, n (%) | 85 (39.9) | 68 (31.9) | 0.09 | 83 (40.9) | 68 (33.2) | 0.11 |