Table 2.
Primary and secondary endpoints
| Tα1 group (N = 254) |
Placebo group (N = 254) |
Risk difference (95% CI) |
p value | |
|---|---|---|---|---|
| Primary endpoint | ||||
| IPN during the index admission, (n, %) | 40 (15.7) | 46 (18.1) | − 2.36 (− 7.41, 5.07) | 0.48 |
| Secondary endpoints* | ||||
| New-onset organ failure | 27 (10.6) | 38 (15) | − 4.26 (− 8.18, 1.93) | 0.15 |
| Respiratory, (n, %) | 9 (3.5) | 17 (6.7) | − 3.15 (− 5.08, 1.08) | 0.11 |
| Renal, (n, %) | 10 (3.9) | 7 (2.8) | 1.25 (− 1.19, 7.48) | 0.43 |
| Cardiovascular, (n, %) | 14 (5.5) | 20 (7.9) | − 2.33 (− 5.00, 2.82) | 0.30 |
| Mortality (n, %) | 18 (7.1) | 22 (8.7) | − 1.55 (− 4.73, 4.21) | 0.52 |
| 90-Day mortality (n, %) | 23 (9.1) | 23 (9.1) | 0.03 (− 3.79, 6.63) | 0.99 |
| IPN within 90 days after randomisation (n, %) | 57 (22.4) | 65 (25.6) | − 3.25 (− 9.18, 4.83) | 0.39 |
| Bleeding, (n, %) | 16 (6.3) | 9 (3.5) | 2.80 (− 0.69, 10.53) | 0.15 |
| Positive blood culture (n, %) | 18 (7.1) | 25 (9.8) | − 2.73 (− 5.85, 2.83) | 0.27 |
| Gastrointestinal fistula, (n, %) | 5 (2) | 6 (2.4) | − 0.41 (− 1.76, 3.91) | 0.75 |
| Length of ICU stay, mean (SD), d | 14.4 (16.2) | 13.6 (16.4) | 0.75 (− 2.07, 3.57) | 0.60 |
| Length of hospital stay, mean (SD), d | 21.0 (21.3) | 20.5 (20) | 0.46 (− 3.12, 4.03) | 0.80 |
| In-hospital cost, mean (SD), Kyuan | 143 (177) | 138 (206) | 5 (− 28, 38) | 0.77 |
| Use of invasive interventions | ||||
| Requiring catheter drainage (n, %)# | 36 (14.2) | 39 (15.4) | − 1.27 (− 6.08, 6.02) | 0.69 |
| Requiring MI debridement (n, %)** | 17 (6.7) | 12 (4.7) | 1.96 (− 1.44, 8.91) | 0.34 |
| Requiring open surgery (n, %) | 8 (3.1) | 5 (2) | 1.14 (− 0.93, 7.37) | 0.41 |
| Number of procedures in patients requiring invasive interventions during the index admission | ||||
| Number of catheter drainage procedures, median (IQR)+ | 2.5 (1–4) | 2 (1–3) | 0.14 (− 0.58, 0.85) | 0.71 |
| Number of MI debridement procedures, median (IQR)++ | 3 (2–6) | 4 (3–5) | − 0.52 (− 1.95, 0.91) | 0.48 |
CI denotes confidential interval. IPN denotes infected pancreatic necrosis. ICU denotes intensive care unit. MI denotes minimally invasive. *All secondary endpoints were registered during the index admission unless otherwise specified; # both percutaneous and transluminal drainage included; **27 patients underwent exclusive percutaneous surgical MI debridement, one patient underwent exclusive endoscopic transluminal debridement, and one combined; + only patients undergoing catheter drainage procedures are included; ++ only patients undergoing MI debridement procedures are included