Table 1. Baseline Characteristics of All Participants and Those With a MODS of More Than 9a.
| Variables | All Participants, No. (%) | MODS >9 Population, No. (%) | ||
|---|---|---|---|---|
| Polymyxin-B Hemoperfusion (n = 224) |
Sham (n = 226) |
Polymyxin-B Hemoperfusion (n = 147) |
Sham (n = 148) |
|
| Age, mean (SD), y | 60.9 (15.1) | 58.8 (14.7) | 59.5 (15.1) | 59.2 (14.0) |
| Sex | ||||
| Women | 84 (37.5) | 93 (41.2) | 51 (34.7) | 57 (38.5) |
| Men | 140 (62.5) | 133 (58.8) | 93 (65.3) | 91 (61.5) |
| Race/ethnicity | ||||
| White | 183 (81.7) | 187 (82.7) | 119 (81.0) | 112 (75.7) |
| Black | 22 (9.8) | 13 (5.8) | 13 (8.8) | 13 (8.8) |
| Hispanic | 10 (4.5) | 12 (5.3) | 7 (4.8) | 10 (6.8) |
| Asian | 3 (1.3) | 9 (4.0) | 2 (1.4) | 8 (5.4) |
| Otherb | 6 (2.7) | 5 (2.2) | 6 (4.1) | 5 (3.4) |
| Arterial pressure, mean (SD), mm Hg | 71.8 (9.9) | 73.3 (10.5) | 71.0 (9.7) | 72.9 (10.6) |
| APACHE II score, mean (SD)c | 29.4 (9.0) | 28.1 (8.5) | 32.0 (8.8) | 30.5 (8.1) |
| MODS score, mean (SD) | 10.0 (3.3) | 10.0 (3.3) | 11.9 (2.0) | 11.9 (1.8) |
| Mechanical ventilation | 208 (93.0) | 217 (96.0) | 142 (97.9) | 147 (99.3) |
| Microorganismsd | ||||
| No growth | 73 (32.9) | 78 (34.7) | 49 (33.3) | 44 (29.7) |
| Gram negative | 53 (23.9) | 30 (13.3) | 36 (24.5) | 21 (14.2) |
| Gram positive | 49 (22.1) | 51 (22.7) | 31 (21.1) | 41 (27.7) |
| Other | 15 (6.8) | 15 (6.7) | 10 (6.8) | 9 (6.1) |
| Mixed | 32 (14.4) | 51 (22.7) | 21 (14.3) | 33 (22.3) |
| Bacteremiae | 72 (33.0) | 62 (28.1) | 48 (33.1) | 45 (30.8) |
| Site of infection | ||||
| Intra-abdominal | 71 (32.4) | 80 (35.7) | 48 (33.6) | 56 (37.8) |
| Lung | 75 (34.3) | 87 (38.8) | 50 (35.0) | 56 (37.8) |
| Mixed | 10 (4.6) | 13 (5.8) | 7 (4.9) | 7 (4.7) |
| Otherf | 63 (28.8) | 44 (19.6) | 38 (26.6) | 29 (19.6) |
| Cumulative vasopressor index, mean (SD)g | ||||
| 0 to ≤5 | 102 (45.7) | 89 (39.4) | 55 (37.7) | 49 (33.1) |
| 6 to ≤10 | 86 (38.6) | 109 (48.2) | 63 (43.2) | 77 (52.0) |
| 11 to ≤15 | 33 (14.8) | 25 (11.1) | 27 (18.5) | 19 (12.8) |
| 16 to ≤20 | 2 (0.9) | 3 (1.3) | 1 (0.7) | 3 (2.0) |
| Norepinephrine dose, mean (SD), μg/kg/min | ||||
| 0 to ≤0.05 | 18 (8.0) | 11 (4.9) | 8 (5.4) | 4 (2.7) |
| 0.05 to ≤0.1 | 34 (15.2) | 27 (12.0) | 22 (15.0) | 15 (10.1) |
| >0.1 | 159 (71.0) | 177 (78.3) | 112 (76.2) | 122 (82.4) |
| Missing or not applicable | 13 (5.8) | 11 (4.9) | 5 (3.4) | 7 (4.7) |
| AKIN AKI stageh | ||||
| No AKI | 59 (26.3) | 59 (26.1) | 26 (17.7) | 27 (18.2) |
| Stage 1 | 28 (12.5) | 31 (13.7) | 18 (12.2) | 19 (12.8) |
| Stage 2 | 33 (14.7) | 27 (12.0) | 19 (12.9) | 18 (12.2) |
| Stage 3 | 104 (46.4) | 109 (48.2) | 84 (57.1) | 84 (56.8) |
| Renal replacement therapy | 47 (21.0) | 62 (27.4) | 37 (25.2) | 45 (30.4) |
| Endotoxin activity assay levels, mean (SD) | 0.77 (0.1) | 0.77 (0.1) | 0.80 (0.2) | 0.80 (0.2) |
| Range, No. (%) | ||||
| 0.60 to 0.69 | 70 (31.3) | 78 (34.5) | 49 (33.3) | 49 (33.1) |
| 0.70 to 0.79 | 54 (24.1) | 63 (27.9) | 28 (19.1) | 39 (26.4) |
| 0.80 to 0.89 | 57 (25.5) | 49 (21.7) | 36 (24.5) | 31 (21.0) |
| 0.90 to 0.99 | 23 (10.3) | 22 (9.7) | 17 (11.6) | 18 (12.2) |
| ≥1.00 | 20 (8.9) | 14 (6.2) | 17 (11.6) | 11 (7.4) |
Abbreviations: AKIN AKI, Acute Kidney Injury Network Acute Kidney Injury; APACHE, Acute Physiology and Chronic Health Evaluation; MODS, Multiple Organ Dysfunction Score.
MODS score measures altered organ function in acutely ill patients using 6 organ systems with weighted scores (range of score, 0 for normal to 4 for the most severe) of each organ system (MODS range, 0-24). A higher score is associated with greater burden of organ dysfunction. A MODS of 9 to 12 points has a hospital mortality of approximately 50%. Prior to the protocol amendment, the MODS score was calculated at baseline. After the amendment, MODS > 9 was included in the screening process and required to obtain EAA.
Race not coded as white, black, Hispanic, or Asian.
APACHE II score severity of disease classification is based on physiologic measures, age, and comorbid conditions. A higher score is associated with greater illness acuity and higher risk of death (APACHE II score range, 0-71). An APACHE II score of 30-34 is associated with a 70% hospital mortality. APACHE II score was obtained at baseline (time of randomization to the initiation of study treatment) using the worst physiologic variable during that period.
Microorganisms were determined by culture from blood, respiratory, urine, fluid, or tissue.
Bacteremia is defined as bacteria in the bloodstream from microbiology reports. No adjudication was performed.
Genitourinary, dermatologic, cardiovascular, or neurological.
CVI score includes cumulative points for equivalent doses of vasopressor support at a point in time. Dose points range from 1-4 for each vasopressor (dopamine, epinephrine, norepinephrine, phenylephrine, and vasopressin). Total CVI score range, 1-20; CVI score 16-20 = 5-6 high-dose vasopressors). CVI score was obtained at baseline with a single score calculated for the vasopressor dose at the time of the assessment.
The AKIN AKI classification scheme for acute kidney injury using changes in baseline serum creatinine and urine output. Range: no AKI to stage 3 AKI. Stage 1 AKI defined as an increase in serum creatinine (SCr) ≥ 0.3 mg/dL over 48 hours or ≥1.5x baseline over 7 days or an episode of urine output (UO) <0.5 mL/kg/h for ≥ 6 hours. Stage 2 AKI defined as an increase in SCr ≥2x baseline or UO <0.5 mL/kg/h for ≥ 12 hours. Stage 3 AKI defined as an increase in SCr ≥3x baseline or UO < 0.3 ml/kg/h for ≥24 hours or anuria for ≥12 hours. Stage 2 and 3 are associated with increased mortality. Among patients with AKI and sepsis, mortality is approximately 30%. AKIN AKI stage was obtained at baseline.