Table 1.
Baseline participant characteristics
| Interferon-gamma group (N = 55) | Placebo group (N = 54) | |
|---|---|---|
| Age, years, median (25–75th percentile) | 57 (41–64) | 58 (44–67) |
| Sex, n/N (%) | ||
| Female | 21/55 (38.2) | 16/54 (29.6) |
| Male | 34/55 (61.8) | 38/54 (70.4) |
| Weight, kg, median (25–75th percentile) | 77 (64–83) | 79 (70–94) |
| Body Mass Index, kg/m2, median (25–75th percentile) | 25 (22–29) | 27 (23–31) |
| Race, n/N (%) | ||
| White | 55/55 (100) | 53/54 (98.1) |
| Asian | 0 (0.0) | 1/54 (1.9) |
| African | 0 (0.0) | 0/54 (0) |
| Functional/Chronic Health status, n/N (%) | ||
| 1–2 (normal activity or moderate limitation) | 52/55 (94.5) | 51/54 (94.4) |
| 3–5 (Severe activity limitation to dependent) | 3/55 (5.5) | 3/54 (5.6) |
| Comorbidities, n/N (%) | ||
| Cardiac insufficiency (NYHA > 2, Marked limitation of physical activity) | 1/55 (1.8) | 3/54 (5.6) |
| Chronic kidney failure (MDRD GFR < 50 mL/min) | 0/55 (0) | 0/54 (0) |
| Neurological history | 5/55 (9.1) | 9/54 (16.7) |
| Chronic obstructive pulmonary disease | 1/55 (1.8) | 3/54 (5.6) |
| Active smoking | 15/55 (27.3) | 19/54 (35.2) |
| Diabetes mellitus | 5/55 (9.1) | 6/54 (11.1) |
| Cancer within 5 last years | 1/55 (1.8) | 4/54 (7.4) |
| Main diagnosis leading to hospitalization, n/N (%) | ||
| Trauma | 27/55 (49.1) | 24/54 (44.4) |
| Medical non-septic | 16/55 (29.1) | 22/54 (40.7) |
| Surgical | 9/55 (16.4) | 6/54 (11.1) |
| Sepsis | 3/55 (5.5) | 2/54 (3.7) |
| Main diagnoses on ICU admission, n/N (%) | ||
| Trauma | 27/55 (49.1) | 24/54 (44.4) |
| Surgical | 17/55 (30.9) | 20/54 (37) |
| Medical non septic | 9/55 (16.4) | 6/54 (11.1) |
| Sepsis | 2/55 (3.6) | 4/54 (7.4) |
| Time from hospitalization to randomization, days median (25–75th percentile) | 1 (1–2) | 1 (1–2) |
| Time from ICU admission to randomization, hours median (25–75th percentile) | 31 (18–43) | 24 (17–33) |
| SAPS-II, median (25–75th percentile) | 45 (37–54) | 45 (37–52) |
| SOFA, median (25–75th percentile) | 7 (5–10) | 7 (5–9) |
| Organ failure at inclusion, yes, n/N (%) | ||
| Neurological/comatosea | 48/55 (87.3) | 43/54 (79.6) |
| Hemodynamicb | 20/55 (36.4) | 15/54 (27.8) |
| Respiratoryc | 7/55 (12.7) | 8/54 (14.8) |
| Kidneyd | 3/55 (5.5) | 4/54 (7.4) |
| Laboratory values at baseline, median (25–75th percentile) | ||
| Total Leukocytes, G/L | 11.4 (9.5–15.6) | 12.9 (10–15.9) |
| Lymphocytes, G/L | 0.9 (0.7–1.2) | 0.9 (0.7–1.3) |
| Neutrophils, G/L | 8.9 (7.4–13) | 10.0 (7.6–13) |
| Monocytes, G/L | 0.9 (0.6–1.2) | 0.9 (0.7–1.2) |
| Creatinine, µmol/L | 63 (54–83) | 65 (53–99) |
| Steroid therapy at inclusion (< 48 h), n/N (%) | 18/55 (32.7) | 12/53 (22.6) |
NYHA New York Heart Association, SAPS-II simplified acute physiological score II, SOFA Sequential Organ Failure Assessment
aComatose, defined as Glasgow coma scale < 13 before sedation
bShock, defined as norepinephrine, epinephrine, or any other vasopressor at a dose of ≥ 0.1 μg per kilogram of body weight per minute or ≥ 0.5 mg per hour for at least 6 h
cDefined as PaO2/FiO2 < 200
dCreatinine blood level > twofold higher than the basal value and/or oliguria < 0.5 mL/kg/h for at less 12 h