Table 1.
Patient baseline characteristics
| Variables | Treatment (n = 53) | Placebo (n = 58) | p value |
|---|---|---|---|
| Age (years) | 70 (62–76) | 69 (62–74) | 0.85 |
| Sex (male) | 20 (37.7) | 22 (37.9) | 0.98 |
| Comorbidities | |||
| Hypertension | 19 (35.9) | 24 (41.4) | 0.55 |
| Diabetes | 16 (30.2) | 21 (36.2) | 0.5 |
| Cardiac disease | 5 (9.4) | 6 (10.3) | 0.87 |
| Cerebrovascular disease | 4 (7.6) | 4 (6.9) | > 0.99 |
| Chronic lung disease | 4 (7.6) | 3 (5.2) | 0.71 |
| Chronic renal disease | 3 (5.7) | 0 (0) | 0.11 |
| Chronic liver disease | 4 (7.6) | 6 (10.3) | 0.74 |
| Solid cancer | 22 (41.5) | 22 (37.9) | 0.7 |
| Hematologic malignancy | 9 (17) | 10 (17.2) | 0.97 |
| Suspected infection focus | 0.67 | ||
| Respiratory infection | 11 (20.8) | 16 (27.6) | |
| Intra-abdominal infection | 27 (50.9) | 24 (41.4) | |
| Urinary tract infection | 10 (18.9) | 10 (17.2) | |
| Other or unknown | 5 (9.4) | 8 (13.8) | |
| Blood culture-positive | 30 (56.6) | 34 (58.6) | 0.83 |
| Vital signs at enrolment | |||
| Mean atrial pressure (mmHg) | 72 (63–81) | 74 (66–83) | 0.32 |
| Respiratory rate (per minute) | 22 (20–26) | 21.5 (18–24) | 0.22 |
| Heart rate (per minute) | 108 (98–125) | 104.5 (92–115) | 0.13 |
| Body temperature (ºC) | 37.6 (36.8–38.3) | 37.4 (36.7–38.1) | 0.37 |
| Laboratory data at enrolment | |||
| White blood cell count (103/L) | 6.1 (1.3–15.4) | 7.6 (1.9–12.6) | 0.75 |
| Platelet count (103/L) | 94 (49–191) | 115 (51–178) | 0.98 |
| Creatinine (mg/dL) | 1.4 (1.1–2.2) | 1.2 (1.1–2.1) | 0.53 |
| Total bilirubin (mg/dL) | 0.9 (0.6–2.4) | 0.9 (0.6–2.6) | 0.88 |
| Albumin (g/dL) | 2.7 (2.4–3.2) | 2.9 (2.3–3.4) | 0.56 |
| Lactate (mmol/L) | 4.4 (2.6–6.2) | 4.0 (2.5–5.3) | 0.26 |
| CRP (mg/dL) | 15.3 (6–26.9) | 13.9 (4.7–25.9) | 0.4 |
| Procalcitonin (mmol/L)a | 19.0 (3.5–57.2) | 16.8 (4.7–48.8) | 0.64 |
| SOFA score at enrolment | 8 (6–10) | 8 (6–10) | 0.85 |
| APACHE II score | 22 (14–32) | 22 (17–32) | 0.82 |
| Acute kidney injury | 0.89 | ||
| Stage 1 | 13 (24.5) | 15 (25.9) | |
| Stage 2 | 13 (24.5) | 17 (29.3) | |
| Stage 3 | 15 (28.3) | 13 (22.4) | |
| Time from ED arrival to the first study drug administration (h) | 8.4 (5.7–14.9) | 9.9 (7.4–15.6) | 0.21 |
| Time from meeting eligibility criteria to the first study drug administration (h) | 3.1 (1.4–7.5) | 3.8 (2–7.4) | 0.61 |
| Time from randomization to the first study drug (h) | 0.8 (0.3–2.1) | 1.2 (0.5–2.5) | 0.23 |
Data are shown as median with interquartile range or n (%)
SOFA sequential organ failure assessment; APACHE acute physiology and chronic health evaluation; ED emergency department
aThere is one missing datum for procalcitonin in the placebo group