Table 1.
Parameter | Total patients (n = 87) | Control group (n = 44) | Intervention (TPE) group (n = 43) | P-value |
---|---|---|---|---|
Age (years) | 49 (34–63) | 49 (33–63) | 48.3 (33.3–63.3) | 0.43 |
Sex male [n (%)] | 72 (82.8) | 36 (81.8) | 36 (83.7) | 0.81 |
BMI (kg/m2) | 26 (21–31) | 25.5 (19.5–32.5) | 27 (22–32) | 0.30 |
Co-morbidities [n (%)] | 41 (47.1) | 19 (43.2) | 22 (51.2) | 0.46 |
Diabetes mellitus [n (%)] | 18/41 (43.9) | 8/19 (42.1) | 10/22 (45.5) | 0.83 |
Hypertension [n (%)] | 35/41 (85.4) | 16/19 (84.2) | 19/22 (86.4) | 0.85 |
Coronary artery disease [n (%)] | 2/41 (4.9) | 1/19 (5.3) | 1/22 (4.5) | 0.92 |
Symptoms onset to ICU admission (days) | 6 (3–9) | 7 (4–10) | 6 (3–9) | 0.19 |
Parameters during hospitalisation | ||||
APACHE II score upon ICU admission | 22 (20–24) | 22 (21–23) | 23 (21–25) | 0.25 |
SOFA score upon ICU admission | 10 (7–13) | 9 (6–12) | 10 (8–13) | 0.07 |
Acute kidney injury requiring CRRT [n (%)] | 12 (13.8) | 6 (13.6) | 6 (14.0) | 0.97 |
Pulmonary embolism [n (%)] | 19 (21.8) | 6 (13.6) | 13 (30.2) | 0.05* |
PaO2/FiO2 ratio at baseline | 125 (65–185) | 125 (75.5–174.5) | 135 (72–198) | 0.50 |
PaO2/FiO2 ratio baseline stratification | ||||
PaO2/FiO2 ratio ≤150 [n (%)] | 50 (57.5) | 27 (61.4) | 23 (53.5) | 0.52 |
PaO2/FiO2 ratio >150 [n (%)] | 37 (42.5) | 17 (38.6) | 20 (46.5) | 0.49 |
Cytokine release syndrome risk group | ||||
Low-risk group (≤3 criteria) [n (%)] | 14 (16.1) | 14 (31.8) | 0 (0) | 0.001* |
High-risk group (>3 criteria) [n (%)] | 73 (83.9) | 30 (68.2) | 43 (100) | 0.001* |
Hospital-acquired infection [n (%)] | 13 (14.9) | 6 (13.6) | 7 (16.3) | 0.85 |
No infections [n (%)] | 74 (85.1) | 38 (86.4) | 36 (83.7) | 0.89 |
Ventilator-associated pneumonia [n (%)] | 8 (9.2) | 4 (9.1) | 4 (9.3) | 0.91 |
Bloodstream infection [n (%)] | 5 (5.7) | 2 (4.5) | 3 (7.0) | 0.73 |
Randomisation and TPE data | ||||
Time to randomisation after ICU admission (days) | 2 (0.5–2.5) | – | – | - |
Onset of TPE after ICU admission (days) | – | – | 2 (1–3) | - |
Number of TPE sessions | – | – | 3 (1–5) | – |
Outcome measures | ||||
Duration of mechanical ventilation (days) | 17 (7–27) | 19 (7.7–30.3) | 15 (8–22) | 0.007* |
ICU length of stay (days) | 22 (8–36) | 26 (11.5–31.5) | 19 (12–27) | 0.02* |
Mortality on Day 35 [n (%)] | 24 (27.6) | 15 (34.1) | 9 (20.9) | 0.09 |
NOTE: Values are median and interquartile range unless otherwise stated.
TPE, therapeutic plasma exchange; BMI, body mass index; ICU, intensive care unit; APACHE, Acute Physiology and Chronic Health Evaluation; SOFA, Sequential Organ Function Assessment; CRRT, continuous renal replacement therapy; PaO2/FiO2, partial arterial pressure of oxygen/fractional inspired concentration of oxygen.
Comparisons between the two groups were considered significant at P ≤ 0.05.