Table 3.
Primary and Secondary Outcomes.*
| Outcome | Intensive Strategy (N = 563) |
Less-Intensive Strategy (N = 561) |
Odds Ratio or Mean Difference (95% CI)† |
P Value | |
|---|---|---|---|---|---|
| Death from any cause by day 60 — no. (%) |
302 (53.6) | 289 (51.5) | 1.09 (0.86 to 1.40) | 0.47 | |
| In-hospital death — no. (%) | 288 (51.2) | 269 (48.0) | 1.15 (0.90 to 1.47) | 0.27 | |
| Discharged to home, off dialysis, by day 60 — no./no. with data (%) |
88/560 (15.7) | 92/561 (16.4) | 0.95 (0.68 to 1.32) | 0.75 | |
| Recovery of kidney function by day 28 — no./no. with data (%)‡ |
0.03 (0.02 to 0.07) | 0.24 | |||
| Complete | 85/553 (15.4) | 102/555 (18.4) | |||
| Partial | 49/553 (8.9) | 50/555 (9.0) | |||
| None | 419/553 (75.8) | 403/555 (72.6) | |||
| RRT-free days through day 28 | 6.0±0.4 | 7.0±0.4 | −0.9 (−1.9 to 0.1) | 0.07 | |
| Hospital-free days through day 60 | 11.0±0.7 | 13.0±0.7 | −1.9 (−3.9 to 0.0) | 0.053 | |
| ICU-free days through day 60 | 18.7±0.9 | 20.1±0.9 | −1.5 (−4.0 to 1.0) | 0.25 | |
| Organ-failure–free days through day 14, according to SOFA organ- system score |
|||||
| Cardiovascular | 7.4±0.2 | 7.4±0.2 | 0.0 (−0.6 to 0.5) | 0.94 | |
| Respiratory | 7.1±0.2 | 7.2±0.2 | −0.1 (−0.8 to 0.5) | 0.71 | |
| Liver | 8.8±0.2 | 8.7±0.2 | 0.0 (−0.6 to 0.7) | 0.91 | |
| Coagulation | 9.0±0.2 | 9.1±0.2 | 0.0 (−0.6 to 0.6) | 0.95 | |
| Central nervous system | 7.1±0.2 | 7.2±0.2 | −0.1 (−0.7 to 0.6) | 0.89 | |
Plus–minus values are adjusted means ±SE. CI denotes confidence interval, ICU intensive care unit, and RRT renalreplacement therapy.
Odds ratios are reported for death by 60 days, in-hospital death, and discharge. Mean differences are reported for all other variables. The odds ratios were calculated with the use of conditional logistic-regression analysis adjusted for site and randomization strata: the Sequential Organ Failure Assessment (SOFA) cardiovascular organ-system score and the presence or absence of oliguria. Except for recovery of kidney function, the mean difference between the group receiving intensive therapy and that receiving less-intensive therapy was calculated with the use of analysis of variance adjusted for the following prespecified baseline covariates: age, sex, SOFA cardiovascular score, and presence or absence of oliguria; the reported mean is a least-squares mean.
Recovery of kidney function was coded as 2 for complete recovery, 1 for partial recovery, and 0 for no recovery; the mean difference between the group receiving intensive therapy and that receiving less-intensive therapy was calculated with the use of weighted least-squares analysis adjusted for the SOFA cardiovascular score and the presence or absence of oliguria.