Table 1. Baseline Characteristics of Patients in the Intensive Care Unit (ICU).
| Characteristic | Balanced solution, No./total (%)a | Saline solution, No./total (%)a,b |
|---|---|---|
| No. of patients | 5230 | 5290 |
| Age, mean (SD), y | 60.9 (17.0) | 61.2 (16.9) |
| Sex, No. (%) | ||
| Female | 2321 (44.4) | 2334 (44.1) |
| Male | 2909 (55.6) | 2956 (55.9) |
| Admission type | ||
| No. of missing patients | 18 | 9 |
| Planned (elective surgery) | 2491/5212 (47.8) | 2588/5281 (49.0) |
| Unplannedc | 2721/5212 (52.2) | 2693/5281 (51.0) |
| Emergency department | 1194/5212 (22.9) | 1188/5281 (22.5) |
| Nonelective surgery | 653/5212 (12.5) | 652/5281 (12.3) |
| Ward | 549/5212 (10.5) | 507/5281 (9.6) |
| Transfer from another hospital | 288/5212 (5.5) | 306/5281 (5.8) |
| Transfer from another ICU | 37/5212 (0.7) | 40/5281 (0.8) |
| Illness severity at enrollment | ||
| APACHE II scored | ||
| No. of patients | 5195 | 5271 |
| No. of missing patients | 35 | 29 |
| Median (IQR) | 12 (8-17) | 12 (8-17) |
| SOFA scoree | ||
| No. of patients | 5195 | 5271 |
| No. of missing patients | 35 | 29 |
| Median (IQR) | 4 (2-7) | 4 (2-7) |
| KDIGO stagef | 1683/5198 (32.4) | 1765/5265 (33.5) |
| No. of missing patients | 32 | 25 |
| Sepsis | 966/5212 (18.5) | 1015/5280 (19.2) |
| No. of missing patients | 18 | 10 |
| Traumatic brain injury | 247/5212 (4.7) | 236/5281 (4.5) |
| No. of missing patients | 18 | 9 |
| Hypotensiong | 3161/5211 (60.7) | 3195/5280 (60.5) |
| No. of missing patients | 19 | 10 |
| Type of mechanical ventilation | ||
| No. of missing patients | 18 | 9 |
| Noninvasive for >12 h | 332/5212 (6.4) | 341/5281 (6.5) |
| Invasive | 2304/5212 (44.2) | 2340/5281 (44.3) |
| Serum creatinine level, mean (SD), mg/dL | ||
| No. of patients | 5187 | 5247 |
| No. of missing patients | 43 | 43 |
| Mean (SD) | 1.2 (0.9) | 1.2 (0.9) |
| Creatinine level, mg/dL | ||
| <1.5 | 4139/5187 (79.8) | 4162/5247 (79.3) |
| 1.6-2.5 | 719/5187 (13.9) | 720/5247 (13.7) |
| >2.5 | 329/5187 (6.3) | 365/5247 (7.0) |
| Cirrhosis or acute liver failure | 132/5212 (2.5) | 135/5281 (2.5) |
| No. of missing patients | 18 | 9 |
| Heart failure | 593/5212 (11.4) | 543/5281 (10.3) |
| No. of missing patients | 18 | 9 |
| Time from ICU admission to randomization, d | ||
| No. of patients | 5212 | 5281 |
| No. of missing patients | 18 | 9 |
| Median (2.5%-97.5%) | 0 (0-1) | 0 (0-1) |
| Administration of balanced solution within the 24 h before enrollmenth | ||
| No. of missing patients | 18 | 10 |
| Received any | 2503/5212 (48.0) | 2561/5280 (48.5) |
| Received >1000 mL | 1626/5212 (31.2) | 1692/5280 (32.0) |
| Volume of balanced solutions adminstered within the 24 h before enrollment | ||
| No. of patients | 5212 | 5280 |
| No. of missing patients | 18 | 10 |
| Median (IQR), mL | 0 (0-1500) | 0 (0-1500) |
| Administration of saline solution within the 24 h before enrollment | ||
| No. of missing patients | 18 | 10 |
| Received any | 1987/5212 (38.1) | 1971/5280 (37.3) |
| Received >1000 mL | 935/5212 (17.9) | 994/5280 (18.8) |
| Volume of saline solution adminstered within the 24 h before enrollment | ||
| No. of patients | 5212 | 5280 |
| No. of missing patients | 18 | 10 |
| Median (IQR), mL | 0 (0-1000) | 0 (0-1000) |
| Administration of any fluid within the 24 h before enrollment | ||
| No. of missing patients | 18 | 10 |
| Received any | 3551/5212 (68.1) | 3609/5280 (68.4) |
| Received >1000 mL | 2327/5212 (44.6) | 2427/5280 (46) |
| Volume of any fluids adminstered within the 24 h before enrollment | ||
| No. of patients | 5212 | 5280 |
| No. of missing patients | 18 | 10 |
| Median (IQR), mL | 1000 (0-2500) | 1000 (0-2500) |
Abbreviations: APACHE II, Acute Physiology and Chronic Health Evaluation II; IQR, interquartile range; KDIGO, Kidney Disease: Improving Global Outcomes; SOFA, Sequential Organ Failure Assessment.
SI conversion factor: To convert creatinine to μmol/L, multiply by 88.4.
Unless otherwise indicated. eTable 1 in Supplement 3 compares all 4 treatment groups.
Saline solution is 0.9% sodium chloride.
Total sum does not include patients whose admission type was imputed; additional details appear in Supplement 3.
Measures illness severity. Scores range from 0 to 71; a higher score indicates more severe disease. A score of 12 predicts an in-hospital mortality rate of 15%.
Measures illness severity. Scores range from 0 to 24; a higher score indicates more severe disease. A score of 4 predicts an in-hospital mortality rate of 20%.
Classifies acute kidney injury. Stages range from 0 (no acute kidney injury) to 3 (severe kidney injury).
Defined as mean arterial pressure of less than 65 mm Hg, systolic blood pressure of less than 90 mm Hg, or vasopressor use.
Plasma-Lyte 148 and lactated ringer.