Table 1. Baseline Characteristics of the Patients.
| Characteristic | Participants, No. (%) | |
|---|---|---|
| Iloprost (n = 142) | Placebo (n = 136) | |
| Age, median (IQR), y | 70 (59-77) | 68 (58-75) |
| Sex | ||
| Female | 54 (38) | 53 (39) |
| Male | 88 (62) | 83 (61) |
| Coexisting conditionsa | ||
| Cardiovascular diseaseb | 73 (51) | 65 (48) |
| Pulmonary diseasec | 44 (31) | 34 (25) |
| Metastatic cancerd | 10 (7) | 13 (10) |
| Active hematologic cancere | 10 (7) | 15 (11) |
| Kidney diseasef | 3 (2) | 5 (4) |
| Source of ICU admission | ||
| Emergency department | 41 (29) | 37 (27) |
| Hospital ward | 70 (49) | 66 (49) |
| Operating or recovery room | 28 (20) | 25 (18) |
| Other ICU | 3 (2) | 8 (6) |
| Primary infectious focus | ||
| Gastrointestinal tract | 57 (40) | 47 (35) |
| Lungs | 33 (23) | 33 (24) |
| Urinary tract | 15 (11) | 13 (10) |
| Skin or soft tissue | 12 (8) | 15 (11) |
| Other | 3 (2) | 11 (8) |
| Unknown | 22 (15) | 17 (13) |
| COVID-19g | 6 (4) | 3 (2) |
| Predicted 90-d mortality, median (IQR)h | 47 (34-57) | 47 (36-57) |
| SOFA score at baseline, median (IQR) | 10 (9-12) | 10 (8-12) |
| Norepinephrine dose at baseline, median (IQR), μg/kg/min | 0.38 (0.03-1.39) | 0.48 (0.06-1.80) |
| Any vasopressor at baseline | 141 (99) | 136 (100) |
| Mechanical ventilation at baseline | 100 (70) | 90 (66) |
| Kidney replacement therapy at baseline | 22 (16) | 34 (25) |
| sTM-concentration at baseline, median (IQR), ng/mL | 20.9 (15.9-27.6) | 20.7 (15.2-26.2) |
| Time from sepsis diagnosis to randomization, median (IQR), min | 392 (241-592) | 348 (222-544) |
| Time from randomization to initiation of treatment with iloprost or placebo, median (IQR), min | 37 (29-55) | 33 (24-50) |
Abbreviations: ICU, intensive care unit; SOFA, Sequential Organ Failure Assessment; sTM, soluble thrombomodulin.
a
These were considered potential effect modifiers and were collected from records review.
b
History of ischemic heart disease, heart failure or atrial fibrillation or flutter.
c
History of chronic obstructive pulmonary disease, asthma, or other chronic pulmonary disease.
d
Metastatic cancer confirmed by surgery or computed tomography scan or otherwise confirmed.
e
Leukemia, lymphoma, or multiple myeloma or plasma cell myeloma.
f
Defined as chronic hemodialysis, hemofiltration, or peritoneal dialysis at least once weekly.
g
Defined as a positive COVID-19 test in the current admission.
h
Based on the Simplified Mortality Score.20