Table 2.
Primary and Secondary Efficacy Endpoints by Treatment Group
| Endpoint | Methylprednisolone (n = 30) | Placebo (n = 30) | P Value | Relative Risk (95% CI) |
|---|---|---|---|---|
| Primary endpoint (any of the following: death, cardiac index ≤2.2 L/min/m2, PaO2/FiO2 ≤55) | 11/30 (37%) | 15/30 (50%) | .44a | 0.73 (.41–1.32) |
| Deaths | 8/30 (27%) | 12/30 (40%) | .41a | 0.67 (.32–1.39) |
| Cardiac index <2.2 L/min/m2 | 1/3 (33%) | 2/6 (33%) | 1.00a | 1.00 (.14–7.09) |
| PaO2/FiO2 ratio ≤55 | 5/28 (18%) | 5/30 (17%) | 1.00a | 1.07 (.35–3.31) |
| Develops shock (only cases without shock at entry) | 4/21 (19%) | 6/15 (40%) | .26a | 0.47 (.16–1.40) |
| Develops respiratory failure requiring mechanical ventilation (only cases not intubated at entry) | 6/26 (23%) | 10/20 (50%) | .07a | 0.46 (.20–1.06) |
| Serum creatinine ≥3.0 mg/dL (only cases <3.0 at entry) | 1/29 (4%) | 6/30 (20%) | .10a | 1.21 (1.00–1.46) |
| Days in hospital, median (25th–75th percentiles) | 8.0 (5.3–11.3) | 10.0 (1.0–16.3) | .5476b | |
| Days in ICU, median (25th–75th percentiles) | 4.0 (2.0–7.0) | 5.0 (1.0–7.0) | .3623b | |
| No. of cases in ICU | 27 cases | 29 cases | ||
| Days of inotropic support, median (25th–75th percentiles) | 2.0 (1.3–2.8) | 3.0 (1.0–5.0) | .6299b | |
| No. of patients who received inotropic support | 12 cases | 20 cases | ||
| Days mechanical ventilation, median (25th–75th percentiles) | 2.0 (1.0–5.0) | 4.5 (1.0–7.0) | .2687b | |
| No. of cases on mechanical ventilation | 11 cases | 20 cases |
Abbreviations: CI, confidence interval; FiO2, fraction of inspired oxygen; ICU, intensive care unit;PaO2, partial pressure of arterial oxygen.
a Fisher exact test.
b Mann-Whitney test.