Table 2.
Primary and secondary endpoints
| CRAI (n = 20) | IV (n = 19) | Difference | P | |
|---|---|---|---|---|
| Primary endpoint | ||||
| Pancreatic necrosis involving more than 1/3 of the pancreas |
25.0% (5), 8.7–49.1% |
15.8% (3), 3.4–39.6% |
− 9.2%, − 39.9 to 20.9% |
0.694 |
| Pancreatic necrosis involving more than 2/3 of the pancreas |
20.0% (4), 5.7–43.7% |
5.3% (1), 0.1–26.0% |
− 14.7%, − 44.5 to 15.9% |
0.341 |
| Secondary endpoints | ||||
| CTSI |
5.3 ± 2.8, 4.0–6.7 |
5.2 ± 1.8, 4.3–6.0 |
0.2, − 1.4 to 1.7 |
0.837 |
| 24-h CFC | ||||
| Day 2 (N) |
0.46 ± 0.21 (9), 0.30–0.62 |
0.85 ± 0.42 (11), 0.56–1.13 |
− 0.39, − 0.72 to − 0.06 |
0.021 |
| Day 3 (N) |
0.50 ± 0.12 (6), 0.37–0.62 |
0.95 ± 0.58 (10), 0.53–1.36 |
− 0.45, − 0.87 to − 0.02 |
0.040 |
| Day 4 (N) |
0.45 ± 0.16 (6), 0.28–0.62 |
0.81 ± 0.69 (9), 0.28–1.34 |
− 0.3613, − 0.90 to 0.18 |
0.163 |
| 24-h AFA | ||||
| Day 2 (N) |
0.7 ± 1.0 (9), − 0.1 to 1.4 |
4.0 ± 3.9 (11), 1.4–6.6 |
− 3.3, − 6.0 to − 0.7 |
0.018 |
| Day 3 (N) |
2.8 ± 3.3 (6), − 0.6 to 6.2 |
5.1 ± 5.1 (10), 1.5–8.7 |
− 2.3, − 7.3 to 2.7 |
0.346 |
| Day 4 (N) |
2.3 ± 4.3 (6), − 2.2 to 6.8 |
4.8 ± 5.7 (9), 0.4–9.1 |
− 2.4, − 8.3 to 3.5 |
0.386 |
| Revised Atlanta classification severe |
35.0% (7), 15.4–59.2% |
26.8% (5), 9.1–51.2% |
8.7%, − 21.2% to 38.8% |
0.731 |
| Highest prognostic score |
3.6 ± 1.9, 2.7–4.5 |
2.8 ± 1.8, 2.0–3.7 |
0.8, − 0.4 to 2.0 |
0.210 |
| Highest CRP (mg/dL) |
27.9 ± 9.5, 23.4–32.3 |
24.9 ± 8.6, 20.7–29.0 |
3.0, − 2.9 to 8.9 |
0.303 |
| Duration of SIRS positivity (days) |
4.0, 2.0–5.0 |
2.0, 1.0–5.0 |
− 1.0, − 3.0 to 0.0 |
0.108 |
| Necrosectomy |
0% (0), 0.0–16.8% |
5.3% (1), 0.1–26.0% |
− 5.3%, − 35.3 to 25.7% |
0.487 |
| Survival | 0.605 | |||
| Day 30 (N at risk) | 100.0% (20) | 94.7% (18) | ||
| Day 60 (N at risk) | 95.0% (19) | 94.7% (18) | ||
| Day 90 (N at risk) | 90.0% (18) | 94.7% (18) | ||
Data are shown as percentage (n), 95% CI; mean ± standard deviation, 95% CI; or median 95% CI. Differences and 95% CIs between the groups are shown in the “Difference” column. Pancreatic necrosis was assessed by blinded central review of contrast-enhanced CT images obtained on Day 14 after the start of the study drug administration. CTSI is the CT severity index. CFC is the cumulative fentanyl consumption. AFA is the additional fentanyl administration. The numbers of participants who underwent pain assessment in the CRAI group were nine on Day 2, six on Day 3, and six on Day 4, while the corresponding numbers in the IV group were 11 on Day 2, 10 on Day 3, and nine on Day 4