Table 1.
Baseline characteristics of the study subjects
| Characteristics | Tα1 group (N = 254) | Placebo group (N = 254) |
|---|---|---|
| Age, mean (SD), y | 44.3 (13.2) | 45.4 (13.4) |
| Gender | ||
| Women, (n, %) | 92 (36.2) | 97 (38.2) |
| Men, (n, %) | 162 (63.8) | 157 (61.8) |
| BMI, mean (SD), kg/m2 | 26.4 (3.9) | 26.8 (4.2) |
| Etiologies | ||
| Alcoholic, (n, %) | 17 (6.7) | 15 (5.9) |
| Biliary, (n, %) | 101 (39.8) | 100 (39.4) |
| Idiopathic, (n, %) | 12 (4.7) | 12 (4.7) |
| Hypertriglyceridemia, (n, %) | 124 (48.8) | 127 (50) |
| Charlson score, mean (SD) | 0.6 (0.7) | 0.5 (0.8) |
| Interval between onset and hospital admission, mean (SD),d | 2.9 (2.5) | 3.0 (1.9) |
| Interval between onset and ICU admission, mean (SD),d | 3.2 (2.7) | 3.2 (1.9) |
| Interval between onset and randomisation, mean (SD),d | 4.2 (2.6) | 4.1 (2) |
| Extent of pancreatic necrosis | ||
| < 30%, (n, %) | 165 (65) | 151 (59.4) |
| 30–50%, (n, %) | 55 (21.7) | 72 (28.3) |
| > 50%, (n, %) | 34 (13.4) | 31 (12.2) |
| Disease severity | ||
| CTSI score, median (IQR) | 6 (5–8) | 6 (5–8) |
| APACHE II score, median (IQR) | 10 (8–13) | 10 (8–13) |
| BISAP score, median (IQR) | 2 (1–2) | 2 (1–2) |
| PASS score, median (IQR) | 235 (190–523) | 235 (190–550) |
| CRP, median (IQR), mg/L | 172.1 (95.4–236.2) | 160.6 (105.5–236.4) |
| Lymphocyte count, median (IQR), × 109/L | 0.9 (0.6–1.2) | 0.9 (0.7–1.2) |
| SOFA score, median (IQR) | 4 (2–6) | 4 (2–6) |
| Respiration, median (IQR) | 2 (1–2) | 2 (1–2) |
| Cardiovascular, median (IQR) | 0 (0–0) | 0 (0–0) |
| Renal, mean median (IQR) | 0 (0–1) | 0 (0–1) |
| Requirement of organ support at randomisation | ||
| Mechanical ventilation, (n, %) | 63 (24.8) | 69 (27.2) |
| Renal replacement therapy, (n, %) | 63 (24.8) | 63 (24.8) |
| Vasoactive agents, (n, %) | 30 (11.8) | 26 (10.2) |
p > 0.05 for the comparison between the groups for all characteristics. SD denotes standard deviation. BMI denotes body mass index. ICU denotes intensive care unit. IQR denotes interquartile range. CTSI denotes computed tomography severity index. APACHE II denotes acute physiology and chronic health evaluation II, which ranges from 0 to 71, with higher scores indicating more severe disease. BISAP denotes bedside index for severity in acute pancreatitis. PASS denotes pancreatitis activity scoring system. CRP denotes C-reactive protein. SOFA denotes sequential organ failure assessment, which ranges from 0 to 24, with higher scores indicating more severe organ failure. Tα1 denotes thymosin α1