Table 2. Primary, Secondary, and Tertiary Outcomes Comparing a Balanced Solution With Saline Solution (0.9% Sodium Chloride).
| Outcomes | No./total (%) | Absolute difference (95% CI) | Effect measure (95% CI) | |
|---|---|---|---|---|
| Balanced solution | Saline solution | |||
| Primary outcome | ||||
| 90-d Mortalitya | 1381/5230 (26.4) | 1439/5290 (27.2) | −1.0 (−2.9 to 0.8) | HR, 0.97 (0.90 to 1.05) |
| P value | .47 | |||
| Secondary outcomes | ||||
| Incidence of acute kidney failure with need for kidney replacement therapy within 90 d per 1000 patient-days | 414/471 (0.88) | 445/476 (0.93) | −0.05 (−0.15 to 0.06) | RR, 0.95 (0.83 to 1.08) |
| At day 1 | 28/5218 (0.5) | 30/5287 (0.6) | ||
| At day 2 | 115/5174 (2.2) | 137/5242 (2.6) | ||
| At day 3 | 181/5052 (3.6) | 213/5123 (4.2) | ||
| At day 7 | 267/4808 (5.6) | 314/4884 (6.4) | ||
| In the hospital (≥1 episode during stay) | 393/5218 (7.5) | 427/5287 (8.1) | −0.5 (−1.5 to 0.4) | OR, 0.93 (0.81 to 1.06) |
| Acute kidney injury assessed as KDIGO stage ≥2b | ||||
| At day 3 | 850/3128 (27.2) | 859/3094 (27.8) | −1.9 (−4.0 to 0.2) | OR, 0.99 (0.88 to 1.11) |
| At day 7 | 276/1180 (23.4) | 273/1170 (23.3) | −1.5 (−3.6 to 0.6) | OR, 1.07 (0.88 to 1.30) |
| KDIGO stage ≥2 or death | ||||
| At day 3 | 851/3128 (27.2) | 865/3094 (28.0) | −1.9 (−4.0 to 0.2) | OR, 0.98 (0.87 to 1.10) |
| At day 7 | 278/1180 (23.6) | 275/1170 (23.5) | −1.5 (−3.6 to 0.6) | OR, 1.07 (0.88 to 1.30) |
| Total SOFA score at day 3c | ||||
| No. of patients | 3789 | 3846 | ||
| Median (IQR) | 4 (2 to 6) | 4 (2 to 6) | 0.09 (−0.02 to 0.16) | |
| SOFA score >2 at day 3 | ||||
| Cardiovasculard | 1319/3789 (34.8) | 1271/3846 (33.0) | 1.7 (−0.4 to 3.9) | OR, 1.11 (1.00 to 1.22) |
| Neurologicale | 654/3789 (17.3) | 636/3846 (16.5) | 0.6 (−0.8 to 1.9) | OR, 1.06 (0.93 to 1.22) |
| Coagulationf | 163/3789 (4.3) | 163/3846 (4.2) | 0 (−0.8 to 0.9) | OR, 1.02 (0.82 to 1.27) |
| Respiratoryg | 266/3789 (7.0) | 258/3846 (6.7) | 0.2 (−0.7 to 1.1) | OR, 1.04 (0.87 to 1.24) |
| Hepatich | 44/3789 (1.2) | 49/3846 (1.3) | −0.1 (−0.5 to 0.3) | OR, 0.94 (0.65 to 1.36) |
| Total SOFA score at day 7c | ||||
| No. of patients | 1531 | 1594 | ||
| Median (IQR) | 4 (2 to 7) | 4 (2 to 7) | 0.27 (0.08 to 0.45) | |
| SOFA score >2 at day 7 | ||||
| Cardiovasculard | 420/1531 (27.4) | 409/1594 (25.7) | 2.0 (−1.0 to 5.1) | OR, 1.14 (0.97 to 1.34) |
| Neurologicale | 492/1531 (32.1) | 415/1594 (26.0) | 5.0 (2.3 to 7.8) | OR, 1.40 (1.18 to 1.66) |
| Coagulationf | 62/1531 (4.0) | 70/1594 (4.4) | −0.1 (−1.3 to 1.0) | OR, 1.01 (0.73 to 1.39) |
| Respiratoryg | 171/1531 (11.2) | 154/1594 (9.7) | 1.3 (−0.4 to 2.9) | OR, 1.21 (0.96 to 1.52) |
| Hepatich | 25/1531 (1.6) | 27/1594 (1.7) | 0 (−0.6 to 0.6) | OR, 1.04 (0.67 to 1.62) |
| Days not requiring mechanical ventilation within 28 d | 0.14 (−0.35 to 0.64) | |||
| No. of patients | 5217 | 5287 | ||
| Median (IQR) | 27 (13 to 28) | 27 (10 to 28) | ||
| Tertiary outcomes | ||||
| Died | ||||
| In the ICU | 907/5218 (17.4) | 922/5287 (17.4) | 0 (−0.6 to 0.6) | OR, 1.01 (0.90 to 1.13) |
| In the hospital | 1177/5218 (22.6) | 1217/5287 (23) | −0.6 (−2.4 to 1.1) | OR, 0.98 (0.88 to 1.09) |
| ICU length of stay, d | ||||
| No. of patients | 5218 | 5287 | ||
| Median (IQR) | 3 (2 to 7) | 3 (2 to 7) | 0 (−0.4 to 0.4) | MR, 0.99 (0.94 to 1.04) |
| Hospital length of stay, d | ||||
| No. of patients | 5218 | 5287 | ||
| Median (IQR) | 8 (5 to 18) | 9 (5 to 18) | −0.3 (−1.1 to 0.5) | MR, 0.98 (0.93 to 1.03) |
Abbreviations: HR, hazard ratio; ICU, intensive care unit; IQR, interquartile range; KDIGO, Kidney Disease: Improving Global Outcomes; MR, mean ratio; OR, odds ratio; RR, risk ratio; SOFA, Sequential Organ Failure Assessment.
Fifteen patients had missing data and their information was imputed.
Measured on specific day and not cumulative.
Measures illness severity. Six organs or systems are assessed and each receives 0 points (no dysfunction) to 4 points (more severe dysfunction). The sum of the scores for all systems ranges from 0 to 24; a higher score indicates more severe illness.
Patient received 5 µg/kg/min or greater dose of dopamine, any dose of epinephrine, or any dose of norepinephrine.
Glasgow Coma Scale score was 9 or less.
Platelet count was 49 000/μL or less.
Ratio of Pao2 to fraction of inspired oxygen was less than 200 mm Hg.
Serum bilirubin level was 6 mg/dL (102.6 μmol/L) or greater.