Table 2. Primary and Secondary Outcomes.
| Outcomes | Intervention (n = 107) | Control (n = 104) | Difference (95% CI) | P Value |
|---|---|---|---|---|
| Primary Outcome | ||||
| Time alive and free of vasopressors, median (IQR), h | 122.1 (76.3 to 145.4) | 124.6 (82.1 to 147.0) | –0.6 (–8.3 to 7.2)a | .83 |
| Secondary Outcomes | ||||
| 28-d Mortality, No. (%) | 24 (22.6) [n = 106] | 21 (20.4) [n = 103] | 2.3 (–8.9 to 13.4) | .69 |
| 90-d Mortality, No. (%) | 30 (28.6) [n = 105] | 25 (24.5) [n = 102] | 4.1 (–8.0 to 16.1) | .51 |
| ICU mortality, No. (%) | 21 (19.6) | 19 (18.3) | 1.4 (–9.2 to 11.9) | .80 |
| Hospital mortality, No. (%) | 25 (23.4) | 21 (20.4) [n = 103] | 3.0 (–8.2 to 14.1) | .60 |
| 28-d Cumulative vasopressor-free days, median (IQR) | 25.6 (17.8 to 26.8) [n = 106] | 25.8 (19.6 to 26.8) [n = 103] | –0.2 (–1.7 to 1.2) | .66 |
| 28-d Cumulative mechanical ventilation-free days, median (IQR) | 25.3 (5.2 to 28.0) [n = 106] | 24.8 (9.5 to 28.0) [n = 103] | 0.4 (–2.6 to 3.4) | .73 |
| 28-d Renal replacement therapy–free days, median (IQR) | 28.0 (23.5 to 28.0) [n = 105] | 28.0 (21.0 to 28.0) [n = 103] | 0.0 (–0.6 to 0.6) | .71 |
| Change in SOFA score at day 3, median (IQR)b | –2 (–4 to 0) [n = 82] | –1 (–3 to 0) [n = 75] | –1.0 (–1.9 to –0.1) | .02 |
| 28-d ICU-free days, median (IQR) | 21.9 (0 to 25.8) [n = 106] | 22.1 (3.9 to 25.8) [n = 103] | –0.2 (–4.1 to 3.7) | .66 |
| Hospital length of stay, median (IQR), d | 12.3 (6.2 to 26.0) | 12.3 (6.2 to 26.1) [n = 103] | 0.0 (–4.9 to 4.9) | .75 |
| Prespecified Exploratory Outcome | ||||
| Acute kidney injury, No. (%) | ||||
| Stage 1 | 18 (16.8) | 14 (13.5) | 3.4 (–6.3 to 13.0) | .80 |
| Stage 2 | 18 (16.8) | 22 (21.2) | –4.3 (–14.9 to 6.2) | |
| Stage 3 | 39 (36.4) | 39 (37.5) | –1.1 (–14.1 to 12.0) | |
Abbreviations: ICU, intensive care unit; IQR, interquartile range; SOFA, Sequential Organ Failure Assessment.
a
Hodges-Lehmann estimate, the median of all paired differences between observations in the intervention group minus the control group.
b
Change in SOFA score: score at day 3 minus score at baseline.