Table 1.
Characteristics of the Patients at Baseline.*
| Characteristic | Restrictive Fluid Group (N = 782) | Liberal Fluid Group (N = 781) | Total (N = 1563) |
|---|---|---|---|
| Age — yr | 59.1±16.0 | 59.9±15.9 | 59.5±15.9 |
| Female sex — no. (%) | 371 (47.4) | 366 (46.9) | 737 (47.2) |
| Race — no. (%)† | |||
| White | 534 (68.3) | 571 (73.1) | 1105 (70.7) |
| Black | 135 (17.3) | 112 (14.3) | 247 (15.8) |
| Asian | 28 (3.6) | 26 (3.3) | 54 (3.5) |
| Other | 10 (1.3) | 6 (0.8) | 16 (1.0) |
| Not reported | 78 (10.0) | 67 (8.6) | 145 (9.3) |
| Hispanic or Latino ethnic group — no. (%)† | |||
| Yes | 118 (15.1) | 108 (13.8) | 226 (14.5) |
| No | 628 (80.3) | 646 (82.7) | 1274 (81.5) |
| Not reported | 36 (4.6) | 27 (3.5) | 63 (4.0) |
| Coexisting conditions — no./total no. (%) | |||
| Diabetes | 222/777 (28.6) | 224/773 (29.0) | 446/1550 (28.8) |
| Chronic heart failure | 99/777 (12.7) | 79/773 (10.2) | 178/1550 (11.5) |
| End-stage renal disease treated with hemodialysis | 33/777 (4.2) | 40/773 (5.2) | 73/1550 (4.7) |
| SOFA score‡ | 3.4±2.8 | 3.5±2.7 | 3.4±2.7 |
| Systolic blood pressure — mm Hg | 93.2±12.0 | 93.8±12.2 | 93.5±12.1 |
| Median time from meeting trial eligibility criteria to randomization (IQR) — min | 61 (26–116) | 60 (25–117) | 61 (26–116) |
| Location at randomization — no. (%) | |||
| Emergency department | 729 (93.2) | 708 (90.7) | 1437 (91.9) |
| ICU | 44 (5.6) | 62 (7.9) | 106 (6.8) |
| Other | 9 (1.2) | 11 (1.4) | 20 (1.3) |
| Median volume of fluid administered before randomization (IQR) — ml | 2050 (1500–2457) | 2050 (1371–2442) | 2050 (1450–2450) |
*
Plus–minus values are means ±SD. ICU denotes intensive care unit, and IQR interquartile range.
†
Race and ethnic group were reported by the patients or their legal representative. More than one race may have been reported per patient. “Other” race included Native American or Pacific Islander.
‡
Sequential Organ Failure Assessment (SOFA) scores range from 0 to 20, with higher scores indicating greater severity.