Table 1. Demographic and Baseline Disease Characteristics.
| Characteristic | Selepressin (n = 562) | Placebo (n = 266) |
|---|---|---|
| Demographics | ||
| Age, mean (SD), y | 66.6 (12.8) | 65.7 (14.6) |
| Sex, No. (%) | ||
| Men | 342 (61) | 145 (55) |
| Women | 220 (39) | 121 (45) |
| Medical patients, No. (%) | 382 (68) | 204 (77) |
| Weight, mean (SD), kg | 80.2 (23.6) | 78.7 (22.2) |
| Body mass index, mean (SD)a | 27.9 (8.4) [n = 559] | 27.5 (7.2) [n = 265] |
| Severity of illness | ||
| Modified SOFA, median (IQR)b | 9 (8-11) [n = 543] | 9 (8-11) [n=258] |
| APACHE II, mean (SD)c | 25.7 (7.8) [n = 559] | 26.0 (7.7) |
| Heart rate, mean (SD), /min | 102 (23) | 101 (23) |
| Mean arterial pressure, median (IQR), mm Hg | 70 (65-76) [n = 561] | 69 (64-76) |
| Norepinephrine, median (IQR), μg/kg/min | 0.25 (0.14-0.45) [n = 561] | 0.26 (0.15-0.44) [n=265] |
| Lactate, median (IQR), mmol/L | 2.7 (1.6-4.5) [n = 526] | 2.6 (1.7-4.2) [n =255] |
| Pao2:Fio2, mean (SD), mm Hg | 221 (118) [n = 514] | 230 (141) [n = 248] |
| Hours of vasopressor therapyd | 8.2 (2.8) | 8.2 (3.0) |
| Site of infection, No. (%) | ||
| Lower respiratory tract | 222 (40) | 99 (37) |
| Intra-abdominal | 159 (28) | 63 (24) |
| Urinary tract | 82 (15) | 51 (19) |
| Skin or soft tissue | 45 (8) | 22 (8) |
| Other | 54 (10) | 31 (12) |
| Preexisting conditions, No. (%) | ||
| Cardiovascular | 332 (59) | 151 (57) |
| Cancer | 182 (32) | 70 (26) |
| Diabetes mellitus | 139 (25) | 67 (25) |
| COPD | 114 (20) | 41 (15) |
| Kidney disease | 93 (17) | 41 (15) |
| Liver cirrhosis | 43 (8) | 23 (9) |
| Charlson Comorbidity Index, mean (SD)e | 2.5 (2.0) [n = 477] | 2.5 (2.1) [n=223] |
Abbreviations: APACHE, Acute Physiologic Assessment and Chronic Health Evaluation; COPD, chronic obstructive pulmonary disease; Fio2, fraction of inspired oxygen; IQR, interquartile range; SOFA, Sequential Organ Failure Assessment.
Calculated as weight in kilograms divided by height in meters squared.
Denotes the SOFA modified to not include Glasgow Coma Scale (range, 0-16, with higher scores indicating more severe or widespread organ dysfunction). For the purpose of the trial, study drug, vasopressin, terlipressin, and phenylephrine attributed 3 points on the cardiovascular scale, and any dose of the positive inotropes milrinone and levosimendan attributed 2 points on the cardiovascular scale.
Scores range from 0 to 71, with higher scores indicating greater severity of illness. A score of approximately 26 for patients with sepsis is typically associated with a short-term mortality rate of 30% to 40%, depending on reason for admission.
Duration of vasopressor treatment administered for sepsis when study drug was initiated.
Measures the effect of coexisting conditions on mortality, with scores ranging from 0 to 29 and higher scores indicating a greater burden of illness. Age was not included in the calculation.