Baseline characteristics and intensive care data*
| Entire SAILS cohort† | Eligible for ALTOS‡ | Patient-reported outcomes evaluation§ | Performance-based physical outcomes evaluation§ | |||||
|---|---|---|---|---|---|---|---|---|
| Rosuvastatin (n=379) | Placebo (n=366) | Rosuvastatin (n=293) | Placebo (n=275) | Rosuvastatin (n=128) | Placebo (n=144) | Rosuvastatin (n=36) | Placebo (n=48) | |
| Baseline patient data | ||||||||
| Age, years | 54 (17) | 54 (16) | 53 (18) | 54 (15) | 50 (16) | 52 (14) | 49 (14) | 50 (15) |
| Women, No (%) | 195 (51) | 185 (51) | 145 (49) | 139 (51) | 68 (53) | 75 (52) | 13 (36) | 27 (56) |
| White, No (%) | 301/365 (82) | 289/356 (82) | 240/288 (83) | 211/267 (79) | 107/126 (85) | 122/141 (87) | 31/35 (89) | 42/47 (89) |
| BMI, kg/m2 | 31.0 (9.9) | 30.4 (10.1) | 31 (9.5) | 30.1 (10) | 31.4 (10) | 31.5 (10) | 35.5 (14) | 29.7 (8) |
| Diabetes, No (%) | 84 (22) | 86 (24) | 60 (20) | 67 (24) | 25 (20) | 37 (26) | 6 (17) | 6 (13) |
| Baseline intensive care data | ||||||||
| Medical ICU admission, No (%) | 330 (87) | 317 (87) | 253 (86) | 239 (87) | 108 (84) | 124 (86) | 28 (78) | 40 (83) |
| APACHE III score | 92 (28) | 95 (28) | 91 (29) | 93 (28) | 87 (27) | 89 (28) | 82 (29) | 84 (30) |
| PaO2/FiO2 ratio (mm Hg) | 170 (71) | 170 (67) | 171 (73) | 171 (67) | 171 (71) | 165 (66) | 182 (74) | 160 (56) |
| PaO2/FiO2 ratio ≤200 (mm Hg), No (%) | 267/371 (72) | 253/361 (70) | 209/289 (72) | 189/272 (69) | 91/127 (72) | 104/143 (73) | 25/36 (69) | 39/48 (81) |
| Baseline shock, No (%) | 173 (46) | 166 (45) | 131 (45) | 119 (43) | 50 (39) | 55 (38) | 15 (42) | 22 (46) |
| Primary lung injury risk factor, No (%) | ||||||||
| Pneumonia | 267/377 (71) | 260/365 (71) | 200/291 (69) | 202/274 (74) | 88/128 (69) | 107/143 (75) | 21/36 (58) | 35/48 (73) |
| Non-pulmonary infection | 72/377 (19) | 73/365 (20) | 58/291 (20) | 49/274 (18) | 30/128 (23) | 25/143 (17) | 11/36 (31) | 11/48 (23) |
| Aspiration | 26/377 (7) | 23/365 (6) | 23/291 (8) | 16/274 (5) | 9/128 (7) | 7/143 (5) | 4/36 (11) | 1/48 (2) |
| Other | 12/377 (3) | 9/365 (2) | 10/291 (4) | 7/274 (3) | 1/128 (1) | 4/143 (3) | 0/36 (0) | 1/48 (2) |
| Organ failure-free days to day 14¶ | ||||||||
| Cardiovascular | 9 (5) | 9 (5) | 9 (5) | 9 (5) | 11 (3) | 10 (4) | 10 (3) | 10 (4) |
| Renal | 10 (5) | 11 (5) | 11 (5) | 11 (4) | 12 (5) | 13 (3) | 11 (5) | 13 (3) |
| Hepatic | 11 (5) | 12 (4) | 11 (5) | 12 (4) | 12 (4) | 13 (3) | 12 (4) | 13 (3) |
| Coagulation | 11 (5) | 11 (5) | 11 (5) | 12 (4) | 12 (4) | 13 (3) | 13 (3) | 13 (3) |
| Ventilator-free days to day 28** | 15 (11) | 15 (11) | 16 (11) | 15 (11) | 20 (7) | 20 (7) | 20 (6) | 20 (8) |
| ICU-free days to day 28 | 14 (10) | 14 (10) | 15 (10) | 15 (10) | 19 (7) | 19 (8) | 19 (8) | 18 (8) |
*Figures are means (SD) unless stated otherwise. Proportions might not add to 100% because of rounding. Median (Q1, Q3) values for continuous variables for the rosuvastatin versus placebo for the ‘eligible for ALTOS’ subset are age: 54 (40, 66) vs 54 (43, 64), BMI: 30 (25, 35) vs 28 (23, 34), APACHE III score: 91 (69, 109) vs 90 (73, 112), PaO2/FiO2 ratio: 163 (120, 205) vs 163 (124, 216), ventilator-free days to day 28: 20 (0, 25) vs 20 (0, 25), ICU-free days to day 28: 19 (4, 24) vs 18 (2, 24), for the ‘patient-reported outcomes evaluation’ subset are age: 52 (37, 62) vs 53 (43, 61), BMI: 30 (25, 36) vs 29 (25, 36), APACHE III score: 84 (68, 105) vs 86 (70, 107), PaO2/FiO2 ratio: 161 (120, 208) vs 153 (118, 210), ventilator-free days to day 28: 23 (18, 25) vs 23 (18, 26), ICU-free days to day 28: 22 (16, 24) vs 21 (16, 25), for the ‘performance-based physical outcomes evaluation’ subset are age: 51 (37, 59) vs 52 (41, 58), BMI: 35 (26, 40) vs 27 (25, 33), APACHE III score: 80 (59, 104) vs 79 (65, 104), PaO2/FiO2 ratio: 162 (132, 216) vs 158 (116, 192), ventilator-free days to day 28: 23 (15, 26) vs 24 (17, 26), ICU-free days to day 28: 22 (14, 25) vs 21 (15, 25).
†The entire cohort of the SAILS trial1 presented alongside cohorts evaluated in this prospective follow-up study.
‡Less than the 745 patient sample size of the SAILS trial due to two sites not participating in this study and a temporary cessation of recruitment into this study.
§Eligible patients from 35 hospitals were recruited for phone-based assessment of patient-reported outcomes. In 12 of these 35 hospitals, patients were also recruited for in-person assessment of their physical performance.
¶Data presented as overall average for each patient's mean value of available daily data. Corticosteroids data available until earlier of 48 h after cessation of mechanical ventilation or day 7. Vasopressor data available until earlier of death, study hospital discharge or day 14. Proportions calculated among days in ICU in which medication data were available. Days without organ failure until day 14 calculated as previously published.
**Those who died before day 28 were assigned 0 ventilator-free days.
ALTOS, ARDSNet Long-Term Outcomes Study; APACHE III, Acute Physiology and Chronic Health Evaluation III; BMI, body mass index; FiO2, fraction of inspired oxygen; ICU, intensive care unit; PaO2, pO2 in arterial blood; SAILS, Statins for Acutely Injured Lungs from Sepsis.