Table 1.
Characteristics at randomization of responders and nonresponders.
| Responders (n = 190) |
Nonresponders (n = 105) |
P value | |
|---|---|---|---|
| Allocated to HES - n (%) | 98 (52) | 42 (40) | 0.06 |
| Age - years | 66 (59-74) | 56 (49-66) | < 0.0001 |
| Male gender - no. (%) | 105 (55) | 65 (62) | 0.27 |
| Included at university hospital - no. (%) | 71 (37) | 37 (35) | 0.72 |
| Surgery1 - no. (%) | |||
| Emergency | 64 (34) | 29 (28) | 0.28 |
| Elective | 24 (13) | 10 (10) | 0.42 |
| Source of sepsis2 - no. (%) | |||
| Lungs | 80 (42) | 59 (56) | - |
| Abdomen | 73 (38) | 24 (23) | - |
| Urinary tract | 26 (14) | 15 (14) | - |
| Soft tissue | 23 (12) | 15 (14) | - |
| Other | 22 (12) | 8 (8) | - |
| SAPS II | 49 (38-58) | 47 (34-55) | 0.16 |
| SOFA score3 | 7 (5-9) | 7 (5-9) | 0.64 |
| Shock4 - no. (%) | 160 (84) | 76 (72) | 0.02 |
| Acute kidney injury5 - no. (%) | 71 (37) | 34 (32) | 0.39 |
| Mechanical ventilation - no. (%) | 98 (52) | 59 (56) | 0.45 |
| Comorbidities | |||
| Diabetes mellitus - no. (%) | 28 (15) | 23 (22) | 0.12 |
| Arterial hypertension - no. (%) | 81 (43) | 33 (31) | 0.06 |
| Chronic renal disease6 - no. (%) | 23 (13) | 20 (21) | 0.11 |
| Hematological malignancy - no. (%) | 15 (8) | 3 (3) | 0.08 |
| Previous admission for - no. (%) | |||
| Heart failure or myocardial infarction | 22 (12) | 9 (9) | 0.42 |
| Stroke | 13 (7) | 11 (10) | 0.27 |
| Asthma or COPD | 24 (13) | 15 (14) | 0.69 |
1Numbers are for patients who underwent surgery during the index hospitalization, but before randomization. 2Some patients had more than one source of infection. The 'other' category included sepsis from a vascular catheter-related infection, meningitis, or endocarditis, as well as sepsis from unknown sources. 3The SOFA scoring was modified because cerebral failure was not assessed. 4Shock at randomization was defined as a mean arterial pressure of less than 70 mm Hg, the need for ongoing treatment with vasopressor or inotropic agents, or a plasma lactate level of more than 4.0 mmol per liter in the hour before randomization. 5Acute kidney injury was defined as a renal SOFA score of 2 or higher (plasma creatinine level > 170 μmol/l (1.9 mg/dl) or urinary output < 500 ml/d). 6Chronic renal disease was defined as a preadmission plasma creatinine > 100 μmol/l (1.2 mg/dl). HES, hydroxyethyl starch; SAPS, simplified acute physiology score; SOFA, sequential organ failure assessment, COPD, chronic obstructive pulmonary disease.