Table 2. Primary and Secondary Outcomes by Treatment Group.
| Outcomesa | Acetaminophen (n = 227) | Placebo (n = 220) | Difference, Mean (95% CI)b | P value | ||
|---|---|---|---|---|---|---|
| No. | Mean (SD)a | No. | Mean (SD) | |||
| Primary outcome | ||||||
| Days free to day 28 | ||||||
| Organ supportc | 223 | 20.2 (10.6) | 218 | 19.6 (10.6) | 0.6 (−1.4 to 2.6) | .56 |
| Assisted ventilation | 223 | 21.5 (10.2) | 218 | 20.5 (10.6) | 1.1 (−0.9 to 3.0) | .29 |
| Vasopressors | 223 | 22.2 (9.4) | 218 | 21.4 (9.5) | 0.8 (−1.0 to 2.6) | .38 |
| Kidney replacement therapy | 223 | 23.7 (9.0) | 218 | 23.6 (8.7) | 0.1 (−1.5 to 1.8) | .89 |
| 28-d All-cause mortality, No. (%) | 223 | 39 (17.5) | 218 | 49 (22.5) | −5.0 (−12.4 to 2.5) | .19 |
| Secondary outcomes | ||||||
| 28-d Hospital mortality, No. (%) | 224 | 37 (16.5) | 218 | 47 (21.6) | −5.0 (−12.4 to 2.3) | .18 |
| Days free to day 28 | ||||||
| Ventilatord | 223 | 20.9 (11.0) | 218 | 19.4 (11.8) | 1.5 (−0.7 to 3.6) | .18 |
| Vasopressorsd | 223 | 21.4 (10.4) | 218 | 20.0 (11.4) | 1.5 (−0.6 to 3.5) | .16 |
| Kidney replacement therapyd | 223 | 22.4 (11.0) | 218 | 21.5 (11.7) | 0.9 (−1.3 to 3.0) | .42 |
| ICUd | 223 | 19.3 (9.9) | 218 | 18.9 (10.1) | 0.4 (−1.5 to 2.3) | .67 |
| Hospitald | 223 | 11.3 (10.9) | 217 | 11.0 (10.8) | 0.2 (−1.8 to 2.3) | .83 |
| ICU days to day 28 | 222 | 5.3 (6.2) | 217 | 5.1 (6.2) | 0.2 (−0.9 to 1.4) | .70 |
| Initiation of assisted ventilation to day 28, No. (%) | 125 | 21 (16.8) | 132 | 23 (17.4) | −0.6 (−9.8 to 8.6) | .89 |
| Initiation of kidney replacement therapy to day 28, No. (%) | 223 | 22 (9.9) | 218 | 18 (8.3) | 1.6 (−3.7 to 7.0) | .56 |
| Change in SOFA score from baseline to day 7 | 148 | −3.2 (3.3) | 153 | −2.9 (3.1) | −0.2 (−0.9 to 0.5) | .53 |
| 90-d Hospital mortality, No. (%) | 224 | 50 (22.3) | 218 | 54 (24.8) | −2.4 (−10.4 to 5.5) | .54 |
| Development of ARDS within 7 d of randomization, No. (%)e | 183 | 4 (2.2) | 188 | 16 (8.5) | −6.3 (−10.8 to −1.8) | .01 |
| Change in serum creatinine (mg/dL)f | 198 | −0.3 (1.0) | 200 | −0.2 (0.9) | −0.1 (−0.2 to 0.1) | .55 |
| MAKE28, No. (%)g | 221 | 55 (24.9) | 218 | 56 (25.7) | −0.8 (−8.9 to 7.3) | .85 |
| 90-d All-cause all-location mortality, No. (%) | 223 | 58 (26.0) | 218 | 69 (31.7) | −5.6 (−14.1 to 2.8) | .19 |
| Any adverse events, No. of eventsh | 36 | 32 | 4 (−12 to 20) | .63 | ||
Abbreviations: ARDS, acute respiratory distress syndrome; ICU, intensive care unit; MAKE28, Major Adverse Kidney Events at 28 days; SOFA, Sequential Organ Failure Assessment.
SI conversion factor: To convert creatinine from mg/dL to μmol/L, multiply by 88.4.
Unless otherwise indicated, values are mean (SD). The percentage and mean were calculated from the nonmissing records.
Differences are either means (for differences in numbers of days or events or in scores/values) or percentage points (for differences between percents).
Days free of organ support to day 28 are all calendar days without vasopressor use, kidney replacement therapy, and assisted ventilation (free of all 3) to day 28 in survivors and nonsurvivors. Days free of vasopressors, kidney replacement therapy, and assisted ventilation are the number of days free of each of these organ supports individually in survivors and nonsurvivors.
Patients who do not survive for 28 days are assigned zero free days. Patients transferred to another hospital or health care facility were followed up to day 28 to assess these end points.
P value is calculated from Fisher exact test.
Change from enrollment to discharge, death, initiation of dialysis or 28 days, whichever occurs first.
Defined as a persistent increase in serum creatinine by 200% from baseline and need for new kidney replacement therapy, or death.
Participants may have had more than 1 adverse event.