Table 1.
Baseline Parameters
| 100 mg IVIb (n = 31) | 200 mg IVIb (n = 30) | 400 mg IVIb (n = 31) | Placebo (n = 28) |
Total (n = 120) |
|
|---|---|---|---|---|---|
| N: Critically Ill | 14 (45%) | 12 (40%) | 14 (45%) | 13 (46%) | 53 (44%) |
| N: Non-Critically Ill | 17 (55%) | 18 (60%) | 17 (55%) | 15 (54%) | 67 (56%) |
| In ICU at BL | 17 (55%) | 15 (50%) | 17 (55%) | 16 (57%) | 65 (54%) |
| On Mechanical Ventilation at BL | 14 (45%) | 12 (40%) | 14 (45%) | 13 (46%) | 53 (44%) |
| On Presssor Support at BL | 2 (7%) | 2 (7%) | 0 (0%) | 0 (0%) | 4 (3%) |
| Age (yrs) | 40.1 (± 19.0 SD) |
34.5 (± 15.0 SD) |
39.2 (± 17.2 SD) |
37.0 (± 19.1 SD) |
37.8 (± 17.5 SD) |
| Gender | 23 M, 8 F | 22 M, 8 F | 22 M, 9 F | 21 M, 7 F | 88 M, 32 F |
| Race | Asian 10; Black 5; Caucasian 13; Hispanic: 2; Haitian 1. |
Asian 10; Black 4; Caucasian 15; Hispanic 1; Haitian 0. |
Asian 10; Black 1; Caucasian 16; Hispanic 4; Haitian 0. |
Asian 10; Black 3; Caucasian 14; Hispanic: 1; Haitian 0. |
Asian 40; Black 13; Caucasian 58; Hispanic 8; Haitian 1. |
| Temperature (/°C) | 39.07 ± 0.61 | 39.07 ± 0.71 | 39.16 ± 0.72 | 38.89 ± 0.48 | N/A |
| Highest Temp Prior to BL (°C) | 39.4 ± 0.7 SD | 39.4 ± 0.6 | 39.4 ± 0.7 | 39.2 ± 0.8 | 39.4 ± 0.7 |
| Heart Rate (bpm) | 106.0 ± 20.4 | 105.4 ± 18.4 | 102.7 ± 18.4 | 102.9 ± 15.4 | 104.3 ± 18.1 |
| Mean Arterial Pressure | 81.7 ± 12.9 | 83.3 ± 11.7 | 87.8 ± 12.7 | 88.1 ± 15.6 | 85.2 ± 13.4 |
|
Height (cm) |
170.3 ± 10.3 | 170.1 ± 10.5 | 168.2 ± 10.1 | 168.8 ± 11.8 | 169.4 (±10.6 SD) |
|
Weight (kg) |
77.9 ± 32.6 | 80.3 ± 29.2 | 72.5 ± 23.4 | 78.4 ± 26.6 | 77.2 (± 28.0) |
| Positive Blood Culture | 13 (42%) (8 ± Malaria) |
13 (43%) (10 ± Malaria) |
12 (39%) 9 ± Malaria |
13 (46%) 10 ± Malaria |
51 (43%) 37 ± Malaria |
| Modified APACHE II | 11.4 (± 7.6 SD) |
12.0 (± 7.7 SD) |
13.4 (± 7.8 SD) |
12.5 (± 9.7 SD) |
12.3 (± 8.1 SD) |
| Glasgow Coma Score | 3 to 8: 4 (13%) 9 to 12: 3 (10%) >13:24 (77%) |
3 to 8: 6 (20%) 9 to 12: 3 (10%) >13:21 (70%) |
3 to 8: 7 (23%) 9 to 12: 4 (13%) >13:20 (65%) |
3 to 8: 5 (18%) 9 to 12: 3 (11%) >13:20 (71%) |
3 to 8: 22 (18%) 9 to 12: 13 (11%) >13:85 (71%) |
|
Emerg. PostOp Elect Post Op Non Operative |
2 (6%) 0 (0%) 29 (94%) |
4 (13%) 0 (%) 26 (87%) |
2 (6%) 3 (10%) 26 (84%) |
1 (4%) 0 (0%) 27 (96%) |
9 (%) 3 (%) 108 (%) |
|
Chronic Conditions (from Modified APACHE II) |
Liver 0(0%) CV 0 (0%) Resp 1(3%) Renal 0(0%) Immun 2(6%) None 28(90%) |
Liver 0(0%) CV 0 (0%) Resp 1(3%) Renal 0 (0%) Immun 2(7%) None 27(90%) |
Liver 0 (0%) CV 0 (0%) Resp 1(3%) Renal 0 (0%) Immun1(3%) None 29 (94%) |
Liver 0 (0%) CV 0 (0%) Resp 1 (4%) Renal 0 (0%) Immun (7%) None 25 (9%) |
Liver 0 0%) CV 0 (0%) Resp 4(3%) Renal 0 (0%) Immun 7(6%) None109 (91%) |
| WBC | 11.6 ± 7.2 | 10.9 ± 6.6 | 9.6 ± 5.0 | 11.6 ± 6.4 | 10.9 ± 6.3 |
| Creatinine (mg/dL) | 0.95 ± 0.26 | .97 ± 0.25 | 0.97 ± 0.35 | 1.0 ± 0.44 | 0.97 (±0.33) |
|
Hematocrit (%) |
36.8 ± 7.7 | 34.1 ± 6.5 | 33.7 ± 6.0 | 34.5 ± 6.9 | 34.8 ± 6.8 |
| Hemoglobin (g/dL) | 12.3 ± 2.5 | 11.4 ± 2.2 | 11.4 ± 2.1 | 11.6 ± 2.3 | 11.7 ± 2.3 |
| Platelet Count | 221.6 (± 158.7) |
189.7 (± 111.3) |
173.6 (±116.3) |
220.0 (±123.61) |
200.9 (± 129.1) |
| Probable Site Infection | None 1(3%); Blood 9 (29%); Lung 9 (29%); Abdom 2 (6%) Other 3 (10%) CNS 2 (6%) Urine Tr 0 (0%) Skin/Tis 2 (6%) Up Resp 2(6%) GYN 0 (0%) IV 1(3%) Unk 2(6%) |
None (3%) Blood 10 (33%) Lung 7 (23%) Abdom 4 (13%) Other 3 (10%) CNS 3 (10%) Urine Tr 0(0%) Skin/Tis1 (3%) Up Resp 0(0%) GYN 0 (0%) IV 0 (0%) Unk 1 (3%) |
None 2 (6%) Blood 10 (32%) Lung 9 (29%) Abdom 1 (3%) Other 4 (13%) CNS 1 (3%) Urine Tr 3 (10%) Skin/Tis 0 (0%) Up Resp1 (3%) GYN 0(0%) IV 0(0%) Unk 0(0%) |
None 2 (7%) Blood 11 (39%) Lung 5 (18%) Abdom 4 (14%) Other 1 (4%) CNS 0 (0%) Urine Tr 2 (7%) Skin/Tis1(4%) Up Resp 0 (0%) GYN 1 (4%) IV 0(0%) Unk 1(4%) |
None 6(5%) Blood 40 (33%) Lung 30 (25%) Abdom 11 (9%) Other 11 (9%) CNS 6(5%) Urine Tr 5 (4%) Skin/Tis 4 (3%) Up Resp 3 (3%) GYN (1%) IV 1(1%) Unk 2(2%) |
BL, Baseline.