Table 2.
Patient demographic and baseline characteristics.
| HES 130/0.4 (n = 100) |
NaCl 0.9% (n = 96) |
|
|---|---|---|
| Gender, n (%) | ||
| - Male | 64 (64) | 57 59) |
| - Female | 36 (36) | 39 (41) |
| Age, years, mean ± SD | 65.8 ± 15.4 | 65.9 ± 14.7 |
| Race, n (%) | ||
| - Caucasian | 96 (96) | 93 97) |
| - Asian | 1 (1) | 1 (1) |
| - Black | 1 (1) | 1 (1) |
| - Other | 2 (2) | 1 (1) |
| Mean body mass index, kg/m2 | 26.2 | 26.0 |
| Type of patient, n (%) | ||
| - Medical | 73 (73) | 70 73) |
| - Surgical | 27 (27) | 26 (27) |
| Renal impairment prior to screening*, n (%) | 62 (63.9) | 65 (68.4) |
| SAPS II prior to randomization, mean | 50 | 53 |
| SOFA at screening, mean | 7.9 | 9.1 |
| Fluid input prior to randomization, ml/kg body weight, mean ± SD | 35.5 ± 25.3 | 39.9 ± 28.6 |
| Origin of sepsis, n (%) | ||
| - Lungs | 53 (53) | 58 (60) |
| - Abdomen | 24 (24) | 18 (19) |
| - Urogenital | 8 (8) | 14 (15) |
| - Skin, bone and soft tissue | 6 (6) | 4 (4) |
| - Other | 5 (5) | 2 (2) |
| - Unknown | 4 (4) | 2 (2) |
| - Neurological system | 3 (3) | 2 (2) |
| - Ear nose and throat | 2 (2) | 0 (0) |
| Causative organism, n (%) | ||
| - Gram-negative bacteria | 35 (35) | 41 (43) |
| - Gram-positive bacteria | 25 (25) | 27 (28) |
| - Other classes | 40 (40) | 32 (33) |
None of the differences were statistically significant; *known serum creatinine >3.39 mg/dl; SD, standard deviation; SAPS II, simplified acute physiology score; SOFA, sequential organ failure assessment; HES, hydroxyethyl starch; NaCI, sodium chloride.