Table 3.
Outcomes.*
| Outcome | Restrictive Fluid Group (N = 782) | Liberal Fluid Group (N = 781) | Difference (95% CI)† | ||
|---|---|---|---|---|---|
| No. of Patients | Mean (95% CI) | No. of Patients | Mean (95% CI) | ||
| Death before discharge home by day 90 — % of patients‡ | 782 | 14.0 (11.6 to 16.4) | 781 | 14.9 (12.4 to 17.4) | −0.9 (−4.4 to 2.6)§ |
| No. of days free from organ-support therapy at 28 days | 778 | 24.0 (23.4 to 24.6) | 778 | 23.6 (23.0 to 24.3) | 0.3 (−0.5 to 1.2) |
| No. of days free from ventilator use at 28 days | 773 | 23.4 (22.7 to 24.1) | 771 | 22.8 (22.0 to 23.5) | 0.6 (−0.4 to 1.6) |
| No. of days free from renal-replacement therapy at 28 days | 737 | 24.1 (23.4 to 24.8) | 738 | 23.9 (23.2 to 24.6) | 0.2 (−0.8 to 1.2) |
| No. of days free from vasopressor use at 28 days¶ | 778 | 22.0 (21.4 to 22.7) | 778 | 21.6 (20.9 to 22.3) | 0.4 (−0.5 to 1.3) |
| No. of days out of the ICU from day 1 to day 28 | 778 | 22.8 (22.2 to 23.4) | 778 | 22.7 (22.0 to 23.3) | 0.1 (−0.8 to 1.0) |
| No of days out of the hospital by day 28 | 778 | 16.2 (15.4 to 17.0) | 778 | 15.4 (14.6 to 16.2) | 0.8 (−0.3 to 1.9) |
| New intubation with invasive mechanical ventilation by 28 days — no. of patients (%) | 701 | 77 (11.0) | 687 | 87 (12.7) | −1.7 (−5.1 to 1.7) |
| Initiation of renal-replacement therapy by 28 days — no. of patients (%) | 738 | 24 (3.3) | 738 | 24 (3.3) | 0.0 (−1.8 to 1.8) |
| KDIGO score on day 3‖ | 585 | 0.35 (0.28 to 0.41) | 604 | 0.34 (0.28 to 0.41) | 0.0 (−0.1 to 0.1) |
| Change in SOFA score from baseline to 72 hr | 619 | −0.7 (−0.9 to −0.4) | 634 | −0.8 (−1.0 to −0.5) | 0.1 (−0.3 to 0.4) |
| Death from any cause at any location by day 90 — no. of patients (%) | 768 | 172 (22.4) | 773 | 169 (21.9) | 0.5 (−3.6 to 4.7) |
| ARDS onset between day 1 and day 7 — no. of patients (%) | 757 | 19 (2.5) | 758 | 20 (2.6) | −0.1 (−1.7 to 1.5) |
| New-onset atrial or ventricular arrhythmia to day 28 — no. of patients (%) | 779 | 59 (7.6) | 778 | 67 (8.6) | −1.0 (−3.7 to 1.7) |
| Severe adverse event — no. of events** | 782 | 21 | 781 | 19 | 2 (−10 to 14) †† |
Percentages and mean values were calculated from nonmissing records. The numbers of patients with data are shown. Confidence intervals have not been adjusted for multiplicity and may not be used for hypothesis testing. ARDS denotes acute respiratory distress syndrome.
Differences are either means (for differences in numbers of days or events or in scores) or percentage points (for differences between percents).
The primary-outcome analysis included all deaths that occurred after randomization in any heath care facility before discharge home until day 90 of the trial. Estimates were from Kaplan–Meier curves. There were 109 deaths and 5 patients with censored data in the restrictive fluid group and 116 deaths and 4 patients with censored data in the liberal fluid group.
P = 0.61.
The analysis excluded vasopressor use during the first 48 hours in order to account for treatment assignment and a washout period.
Kidney International Improving Global Outcomes (KDIGO) scores range from 1 to 3, with a score of 3 indicating the worst renal function.
All the adverse events are listed in Tables S14 and S15. Participants may have had more than one adverse event.
P = 0.75.