Table 2 28-Day all-cause mortality by study and by selected subgroups

PAFase (Opal et al. 2004) [28]

Severe sepsis (1,261)

Primary

24% (150/618)

25% (161/643)

APACHE II score:

   <16

13% (16/122)

11% (16/146)

   16–20

21% (31/151)

19% (30/158)

   21–25

22% (35/156)

25% (44/173)

   >25

36% (68/188)

43% (70/162)

TFPI (Abraham et al. 2003) [29]

Severe sepsis (1,955)

All patients

33% (323/992)

32% (311/963)

Primary:

   INR ≥ 1.2

34% (296/874)

34% (301/880)

   INR <1.2

23% (27/118)

12% (10/83)

Shock and INR ≥ 1.2:

   Yes

35% (234/666)

36% (231/635)

   No

30% (62/208)

29% (70/245)

APACHE II score and INR ≥ 1.2:

   <20

22% (45/207)

18% (33/188)

   ≥20

37% (249/665)

39% (267/689)

Low-dose steroids (Annane et al. 2002) [27]

Septic shock (299)

All patients

61% (91/149)

55% (82/150)

Primary:

   Nonresponder to corticotropin stimulation test

63% (73/115)

53% (60/114)

   Responder

53% (18/34)

61% (22/61)

ATIII (Warren et al. 2001) [35]

Severe sepsis (2,314)

Primary

39% (448/1,157)

39% (449/1,157)

Shock:

   Yes (n = 1,118)

43%

44%

   No (n = 1,191)

35%

34%

SAPS II score:

   <30% (n = 652)

19%

22%

   30–60% (n = 1,008)

41%

37%

   >60% (n = 654)

55%

59%

Ibuprofen (Bernard et al. 1997) [44]

Severe sepsis (455)

Primary

40% (92/231)

37% (83/224)

Shock:

   Yes

45% (66/147)

42% (61/146)

   No

31% (26/84)

28% (22/78)

IL-1ra (1st phase III) 1 mg/kg per hour (Fisher et al. 1994 [32]; Knaus et al. 1996 [6])

Severe sepsis (600)

Low dose

34% (102/302)

31% (91/298)

Shock:

   Yes

36% (85/239)

31% (76/244)

   No

27% (17/63)

28% (15/54)

Predicted risk for death:

   ≥24%

45% (85/189)

38% (72/192)

   <24%

15% (17/113)

18% (19/106)

Organ dysfunctions at baseline:

   None

19% (22/115)

13% (14/105)

   1 or more

43% (80/187)

40% (77/193)

IL-1ra (1st phase III) 2 mg/kg per hour (Fisher et al. 1994) [32]

Severe sepsis (595)

High dose

34% (102/302)

29% (86/293)

Shock:

   Yes

36% (85/239)

31% (71/230)

   No

27% (17/63)

24% (15/63)

Predicted risk of death

   ≥24%

45% (85/189)

35% (70/199)

   <24%

15% (17/113)

17% (16/94)

Organ dysfunctions at baseline:

   None

19% (22/115)

24% (26/110)

   1 or more

43% (80/187)

33% (60/183)

IL-1ra (2nd phase III) 2 mg/kg per hour (Opal et al. 1997) [34]

Severe sepsis (906)

Primary

36%

34%

Evaluable

36% (126/346)

33.1% (116/350)

Predicted risk for death

   ≤24% (n = 461)

42%

42%

   <24% (n = 235)

24%

18%

Organ dysfunctions at baseline:

   None

24% (22/91)

18% (17/93)

   Single

36% (47/132)

32% (43/134)

   Multiple

46% (57/123)

46% (56/123)

ARDS:

   Yes (n = 173)

38%

37%

E5 (1st phase III study; Greenman et al. 1991) [30]

Severe sepsis (468)

All Patients

41%

40%

Primary:

   Gram-negative sepsis

41% (62/152)

38% (62/164)

G-ram-negative sepsis by shock status:

   No (n = 137)

43%

30%

   Yes (n = 179)

40%

45%

E5 (2nd phase III study; Bone et al. 1995) [52]

Severe sepsis (530)

Primary

26% (69/266)

30% (79/264)

Organ dysfunctions at baseline:

   0 (391)

18% (36/196)

26% (51/195)

   ≥1 (139)

47% (33/70)

41% (28/69)

E5 (3rd phase III study; Angus et al. 2000) [45]

Severe sepsis (1,090)

Primary

40% (219/544)

38% (210/546)

Shock:

   Yes

46% (145/317)

46% (140/304)

   No

33% (74/227)

29% (70/242)

Hypotension:

   Yes

43% (176/409)

43% (168/393)

   No

32% (43/135)

28% (70/242)

Lenercept (Abraham et al. 2001) [33]

Severe sepsis (1,342)

Primary

28% (190/680)

27% (178/662)

SAPS II risk quartile:

   0–18%

13% (23/178)

15% (25/164)

   19–31%

19% (34/178)

25% (39/155)

   32–45%

33% (53/160)

25% (43/172)

   >45%

51% (84/164)

42% (72/171)

Hypotension:

   Yes

32% (36/111)

42% (47/111)

   No

28% (159/569)

24% (132/551)

Organ dysfunctions at baseline:

   0

18% (30/164)

20% (33/164)

   1

25% (78/319)

23% (71/310)

   2

37% (54/145)

33% (44/134)

   ≥3

52% (27/52)

56% (30/54)

ARDS:

   Yes

35% (35/101)

30% (31/104)

MAK 195F (Reinhart et al. 2001) [46]

Septic shock (446) (IL-6 level > 1,000 pg/ml)

Primary

58% (128/222)

54% (121/224)

BAYx1351 (1st phase III study) 7.5 mg/kg (Cohen and Carlet 1996) [47]

Severe sepsis (648)

Low Dose

33% (108/326)

30% (95/322)

Shock:

   Yes

46% (76/160)

38% (59/156)

   No

21% (35/166)

22% (36/166)

BAYx1351 (1st phase III study) 15 mg/kg (Cohen and Carlet 1996) [47]

Severe sepsis (649)

High dose

33% (108/326)

31% (101/323)

Shock:

   Yes

46% (76/160)

38% (61/162)

   No

21% (35/166)

25% (40/161)

BAYx1351 (2nd phase III study) 3 mg/kg (Abraham et al. 1995) [31]

Severe sepsis (348)

Low dose

40% (66/167)

31% (57/181)

Shock:

   Yes

43% (57/133)

37% (51/139)

   No

26% (9/34)

14% (6/42)

Shock patients by APACHE II score:

   ≤24

35% (25/72)

22% (18/82)

   >24

53% (31/59)

57% (32/56)

BAYx1351 (2^nd phase III study) 15 mg/kg (Abraham et al. 1995) [31]

Severe sepsis (372)

High dose

40% (66/167)

42% (87/205)

Shock:

   Yes

43% (57/133)

45% (66/148)

   No

26% (9/34)

37%% (21/57)

Shock patients by APACHE II score:

   ≤24

35% (25/72)

36% (30/84)

   >24

53% (31/59)

56% (36/64)

BAYx1351 (3rd phase III study; (Abraham et al. 1998) [36]

Septic shock (1,869)

Primary

43% (398/930)

40% (382/948)

IL-6 concentration:

   ≤1,000 pg/ml

36% (134/369)

33% (113/341)

   >1,000 pg/ml

47% (264/561)

44% (269/607)

rhAPC (Bernard et al. 2001 [26]; Ely et al. 2003 [24])

Severe sepsis (1,960)

Primary

31% (259/840)

25% (210/850)

Organ dysfunctions at baseline:

   1

21% (43/203)

20% (42/215)

   2

26% (71/273)

21% (56/270)

   3

34% (75/218)

26% (56/214)

   4

47% (54/116)

39% (46/119)

   5

53% (16/30)

32% (10/31)

IL-6 concentration quartile (low to high):

   1st

22% (48/217)

11% (20/191)

   2nd

27% (50/189)

26% (58/220)

   3rd

33% (67/202)

29% (59/207)

   4th

44% (87/200)

31% (65/209)

APACHE II score quartile:

   3–19

12% (26/215)

15% (33/218)

   20–24

26% (57/222)

23% (49/218)

   25–29

36% (58/162)

24% (48/204)

   30–55

49% (118/241)

38% (80/210)

Protrombin time:

   <14.5 s (n = 103)

28%

16%

   14.5–17.4 s (n = 1,039)

26%

17%

   >17.4 s (n = 81)

51%

39%

PAFra (Dhainaut et al. 1998) [48]

Severe sepsis (608)

Primary

49% (153/308)

47% (140/300)

MAB-T88 (Albertson et al. 2003) [49]

Severe sepsis (826)

All patients

34% (141/415)

37% (152/411)

Primary:

   Enterobacteriaceae infection

31% (70/227)

34% 978/229)

NOS inhibitor (Lopez et al. 2004) [50]

Severe sepsis (797)

All Patients

49% (174/358)

59% (259/439)

HA-1A (Ziegler et al. 1991) [25]

Severe sepsis (200)

All patients

43% (118/276)

39% (100/255)

Primary:

   Gram-negative bacteremia

49% (45/92)

30% (32/105)

APACHE II score:

   ≤25

38% (20/52)

20% (12/62)

   >25

60% (26/43)

48% (21/43)

Shock:

   No

40% (18/45)

27% (14/51)

   Yes

57% (27/47)

33% (18/54)

Afelimomab (Panacek et al. 2004) [37]

Severe sepsis (2,634)

All patients

36% (477/1,329)

32% (421/1,305)

Primary:

   IL-6 level > 1,000 pg/ml

48% (243/510)

44% (213/488)

   IL-6 level < 1,000 pg/ml

29% (234/819)

25% (208/817)

Filgrastim (Root et al. 2003) [51]

Pneumonia + severe sepsis (701)

All Patients

25% (90/353)

29% (101/348)