Characteristic | Usual care before vs. during the trial | Usual care pre-trial vs. non-enrolled vs. usual care controls | |||
---|---|---|---|---|---|
Pre-trial period (N = 200) | During-trial period (N = 229) | Pre-trial group (N = 200) | Non-enrolled group (N = 155) | Usual care control group (N = 74) | |
Age, years (mean [SD]) | 74.5 (7.2) | 75.2 (6.9) | 74.5 (7.2) | 75.1 (6.8) | 75.4 (7.2) |
Males (n - %) | 110 (55) | 148 (64.6) | 110 (55) | 101 (65.2) | 47 (63.5) |
APACHE II score (median [IQR]) | 26 (20–31) | 26 (21–31) | 26 (20–31) | 27 (22–31) | 25.5 (20–29) |
Comorbidities (n [%]) | |||||
Cardiac | |||||
Supraventricular arrhythmia | 48 (24) | 66 (28.8) | 48 (24) | 47 (30.3) | 19 (25.7) |
Ventricular arrhythmia | 0 (0) | 3 (1.3) | 0 (0) | 3 (1.9) | 0 (0) |
Angina, MI, previous PCI, or CABG | 51 (25.5) | 63 (27.5) | 51 (25.5) | 55 (35.5) | 8 (10.8) |
CHF class I-III | 24 (12.1) | 42 (18.3) | 24 (12.1) | 32 (20.7) | 10 (13.5) |
CHF class IV | 3 (1.5) | 5 (2.2) | 3 (1.5) | 0 (0) | 5 (6.8) |
Vascular | |||||
Chronic hypertension | 126 (63) | 153 (66.8) | 126 (63) | 102 (65.8) | 51 (68.9) |
Peripheral vascular disease or claudication | 37 (18.5) | 29 (12.7) | 37 (18.5) | 23 (14.8) | 6 (8.1) |
Cerebrovascular disease | 19 (9.5) | 40 (17.5) | 19 (9.5) | 22 (14.2) | 18 (24.3) |
Endocrine | |||||
Diabetes | 75 (37.5) | 87 (38) | 75 (37.5) | 57 (36.8) | 30 (40.5) |
Renal | |||||
Chronic dialysis | 15 (7.5) | 9 (3.9) | 15 (7.5) | 4 (2.6) | 5 (6.8) |
Gastrointestinal | |||||
Moderate to severe liver disease | 7 (3.5) | 9 (3.9) | 7 (3.5) | 6 (3.9) | 3 (4.1) |
Respiratory | |||||
Chronic lung disease | 54 (27) | 66 (28.8) | 54 (27) | 50 (32.3) | 16 (21.6) |
Immunosuppression | |||||
Chemotherapy or chronic immunosuppressive | 42 (21) | 35 (15.3) | 42 (21) | 28 (18.1) | 7 (9.5) |
medications or transplantation | |||||
Neurologic | |||||
Cognitive impairment | 16 (8) | 16 (7) | 16 (8.0) | 14 (9) | 2(2.7) |
Reason for ICU Admission (n [%]) | |||||
Medical | |||||
Cardiovascular/Vascular | 3 (0.7) | 10 (2.3) | 3 (0.7) | 9 (2.1) | 1 (0.2) |
Respiratory | 38 (8.9) | 52 (12.1) | 38 (8.9) | 40 (9.3) | 12 (2.8) |
Gastrointestinal | 11 (2.6) | 13 (3.0) | 11 (2.6) | 8 (1.9) | 5 (1.2) |
Sepsis | 99 (23.1) | 101 (23.5) | 99 (23.1) | 64 (14.9) | 37 (8.6) |
Other | 8 (1.9) | 8 (1.9) | 8 (1.9) | 3 (0.7) | 5 (1.2) |
Surgical | |||||
Cardiovascular/vascular | 4 (0.9) | 3 (0.7) | 4 (0.9) | 3 (0.7) | 0 (0) |
Respiratory | 14 (3.3) | 6 (1.4) | 14 (3.3) | 6 (1.4) | 0 (0) |
Gastrointestinal | 19 (4.4) | 30 (7.0) | 19 (4.4) | 18 (4.2) | 12 (2.8) |
Other | 4 (0.9) | 6 (1.4) | 4 (0.9) | 4 (0.9) | 2 (0.5) |
Life support at baseline (n [%]) | |||||
Invasive ventilation | 102 (51.0) | 144 (62.9) | 102 (51.0) | 95 (61.3) | 49 (66.2) |
Non-invasive ventilation | 75 (37.5) | 50 (21.8) | 75 (37.5) | 33 (21.3) | 17 (23) |
Renal replacement therapy | 17 (8.5) | 10 (4.4) | 17 (8.5) | 6 (3.9) | 4 (5.4) |
MAP at inclusion, mmHg (mean [SD]) | 68.2 (13.7) | 70 (13.1) | 68.2 (13.7) | 68.9 (14.4) | 72.2 (9.7) |
Vasopressor dose-rate at inclusion, ug/kg/min (mean [SD]) | 0.15 (0.23) | 0.15 (0.18) | 0.15 (0.23) | 0.13 (0.17) | 0.19 (0.19) |