Table 3.
Key End points
| Parameter | Modified Intent-to-Treat Population |
|||
|---|---|---|---|---|
| Intervention (N = 83) | Usual Care (N = 41) | Treatment Difference in Mean or Percentage (95% CI) | P Valuea,b | |
| Primary efficacy end point | ||||
| Fluid balance at 72 h or ICU discharge, L | ||||
| Mean ± SD (No.) | 0.65 ± 2.85 (83) | 2.02 ± 3.44 (41) | −1.37 (−2.53 to −0.21) | .021 |
| Median (Q1, Q3) | 0.53 (−0.84, 2.53) | 1.22 (−0.03, 3.73) | … | … |
| Secondary end points for formal testing | ||||
| Requirement for renal replacement therapy,c % (n/N) | 5.1 (4/79) | 17.5 (7/40) | −12.4% (−0.27 to −0.01) | .042∗∗ |
| Requirement for ventilator use,d % (n/N) | 17.7 (14/79) | 34.1 (14/41) | −16.42% (−0.33 to 0.00) | .044∗∗ |
| Length of ICU stay,e d | ||||
| Mean ± SD (No.) | 3.31 ± 3.51 (74) | 6.22 ± 10.72 (35) | −2.91 (−6.67 to 0.85) | .113 |
| Median (Q1, Q3) | 2.09 (0.85, 3.75) | 2.90 (1.27, 3.80) | … | … |
| Ventilator use (30-day period),f h | ||||
| Mean ± SD (No.) | 46.99 ± 52.33 (14) | 119.42 ± 134.90 (14) | −72.43 (−154.08 to 9.22) | .079 |
| Median (Q1, Q3) | 20.47 (6.23, 59.04) | 75.60 (10.49, 213.63) | … | … |
| Vasopressor use,g h | ||||
| Mean ± SD (No.) | 40.74 ± 51.23 (55) | 55.64 ± 87.42 (26) | −14.91 (−52.50 to 22.68) | .426 |
| Median (Q1, Q3) | 20.98 (7.62, 45.27) | 30.85 (13.75, 47.60) | … | … |
| Changes in serum creatinine levels from baseline to 72 hh | ||||
| Mean ± SD (No.) | 0.13 ± 1.10 (79) | 0.04 ± 0.97 (34) | 0.09 (−0.34 to 0.52) | .453 |
| Median (Q1, Q3) | 0.00 (−0.19, 0.23) | −0.11 (−0.39, 0.12) | … | … |
| Exploratory end point: loop diuretic use, % (n/N) | ||||
| 0 to 24 h | 6.0 (5/83) | 9.8 (4/41) | −3.7% (−14.2% to 6.7%) | .451 |
| 24 to 48 h | 3.6 (3/83) | 12.2 (5/41) | −8.6% (−19.4% to 2.2%) | .067 |
| 48 to 72 h | 6.0 (5/83) | 7.3 (3/41) | −1.3% (−10.8% to 8.2%) | .783 |
| Discharge location, % (n/N) | ||||
| Home | 63.9 (53/83) | 43.9 (18/41) | 20.0% (1.6% to 38.3%) | .035 |
| Otheri | 36.1 (30/83) | 56.1 (23/41) | … | … |
See Table 1 legend for expansion of abbreviation.
Student t-test was used to compare the treatment groups.
Testing of the secondary end points followed a predefined hierarchic sequence. Because the the primary end point was met, secondary end points were tested in this manner. End points were tested at a two-sided alpha of .05. Formal testing under this predefined criterion is intended to account for multiple is intended to account for multiple comparisons and prevent the likelihood of a false finding. Significance is denoted with an asterisk; the successful passing of the hierarchic order denoted by a double asterisk.
Patients who entered the study on dialysis were excluded from the RRT end point, which was tested by Fisher exact test for proportions.
Patients who entered the study on ventilation were excluded from the end point, which was tested using a Chi-squared test for proportions.
Patients who died while in the ICU were censored from the analysis; the Wilcoxon Rank Sum test was used for the statistical analysis.
Patients who did not enter the study on ventilation, but required ventilator use during the study, were included in the analysis.
Patients who had vasopressors initiated throughout the trial are included in this analysis.
Change from baseline was defined as the change in serum creatinine from the earliest value collected to 72 hours after enrollment or ICU discharge; an analysis of variance that adjusted for baseline creatinine was used to compare groups.
Includes extended care facility, rehab facility, hospital, unknown, and other.