Table 1 Baseline characteristics by steroid use for treatment of septic shock at baseline and randomized treatment of all patients

Number

436

414

403

442

Age, years

0.1007

Median (25th, 75th percentile)

64.4 (52.5, 74.2)

66.2 (55.4, 76.0)

66.2 (54.5, 76.6)

63.6 (51.4, 75.2)

Female, n/total (%)

190/436 (43.6%)

169/414 (40.8%)

185/403 (45.9%)

194/442 (43.9%)

0.5350

Prior or preexisting conditions

Alcohol dependence

58/436 (13.3%)

59/414 (14.3%)

53/403 (13.2%)

61/442 (13.8%)

0.9604

Chronic liver disease

18/436 (4.1%)

11/414 (2.7%)

12/403 (3.0%)

17/442 (3.8%)

0.6109

Chronic obstructive airways disease

69/436 (15.8%)

59/414 (14.3%)

66/403 (16.4%)

65/442 (14.7%)

0.8084

Chronic renal disease

49/436 (11.2%)

35/414 (8.5%)

30/403 (7.4%)

37/442 (8.4%)

0.2380

Congestive heart failure

27/436 (6.2%)

21/414 (5.1%)

22/403 (5.5%)

23/442 (5.2%)

0.8837

Coronary artery disease

57/436 (13.1%)

55/414 (13.3%)

37/403 (9.2%)

49/442 (11.1%)

0.2024

Diabetes mellitus

100/436 (22.9%)

89/414 (21.5%)

90/403 (22.3%)

126/442 (28.5%)

0.0618

Hypertension

190/436 (43.6%)

191/414 (46.1%)

201/403 (49.9%)

201/442 (45.5%)

0.3341

Immunodeficiency

40/436 (9.2%)

11/414 (2.7%)

41/403 (10.2%)

18/442 (4.1%)

<0.0001

Malignancy (cancer)

81/436 (18.6%)

64/414 (15.5%)

83/403 (20.6%)

64/442 (14.5%)

0.0629

Pancreatitis

18/436 (4.1%)

12/414 (2.9%)

13/403 (3.2%)

12/442 (2.7%)

0.6509

Stroke

25/436 (5.7%)

23/414 (5.6%)

19/403 (4.7%)

25/442 (5.7%)

0.9048

Positive blood culture

143/436 (32.8%)

127/414 (30.7%)

122/403 (30.3%)

117/442 (26.5%)

0.2262

Source control of infection^b

138/151 (91.4%)

137/152 (90.1%)

133/149 (89.3%)

131/146 (89.7%)

0.9355

Number of baseline organ dysfunctions

<0.0001

1

8/436 (1.8%)

10/414 (2.4%)

6/403 (1.5%)

17/442 (3.8%)

2

41/436 (9.4%)

74/414 (17.9%)

35/403 (8.7%)

77/442 (17.4%)

3

133/436 (30.5%)

144/414 (34.8%)

132/403 (32.8%)

162/442 (36.7%)

4

185/436 (42.4%)

142/414 (34.3%)

162/403 (40.2%)

154/442 (34.8%)

5

69/436 (15.8%)

44/414 (10.6%)

68/403 (16.9%)

32/442 (7.2%)

Time from start of vasopressor to infusion start, hours

0.1390

Median (25th, 75th percentile)

19.1 (13.0, 22.7)

17.0 (13.0, 21.5)

18.2 (12.8, 22.0)

18.0 (11.6, 22.2)

Apache II score

<0.0001

Median (25th, 75th percentile)

25.0 (20.0, 31.0)

24.0 (19.0, 30.0)

26.0 (21.0, 32.0)

23.0 (18.0, 29.0)

Recent surgery

159/436 (36.5%)

157/414 (37.9%)

143/403 (35.5%)

165/442 (37.3%)

0.8968

Mechanical ventilation

379/436 (86.9%)

316/414 (76.3%)

361/403 (89.6%)

339/442 (76.7%)

<0.0001

Renal replacement therapy

88/432 (20.4%)

32/413 (7.7%)

80/402 (19.9%)

27/442 (6.1%)

<0.0001

Acute respiratory distress syndrome

144/436 (33.0%)

80/414 (19.3%)

123/403 (30.5%)

114/442 (25.8%)

<0.0001

Intravenous fluids from start of vasopressor to start of study drug, mL

0.0093

Median (25th, 75th percentile)

4858 (3210, 7840)

4458 (2746, 6865)

4635 (2904, 7508)

4222 (2755, 6460)

Intravenous fluids in 24 hours before start of vasopressors, mL

<0.0001

Median (25th, 75th percentile)

2902 (1850, 4384)

3250 (2197, 5100)

2850 (1600, 4350)

3250 (2105, 5000)

Vasopressor score

<0.0001

Median (25th, 75th percentile)

50.0 (23.0, 98.0)

27.0 (12.2, 46.4)

50.0 (22.9, 90.9)

21.9 (12.6, 44.4)

Total sequential organ failure assessment

<0.0001

Median (25th, 75th percentile)

11.0 (9.0, 13.0)

10.0 (8.0, 12.0)

11.0 (9.0, 13.0)

10.0 (8.0, 12.0)

Lactate, mmol/L

<0.0001

Median (25th, 75th percentile)

3.0 (1.9, 4.8)

2.2 (1.4, 3.3)

3.1 (2.0, 5.1)

2.1 (1.4, 3.3)