Table 2.
Outcomes. CI, confidence interval; ICU, intensive care unit; IQR, inter-quartile range; SAE, serious adverse event. ∗Data regarding primary outcome were missing for one patient in the higher oxygenation group. †Stratification variables: trial site and active haematological malignancy for 90-day mortality. ‡Baseline characteristics: age; active metastatic cancer; type of admission (medical, elective surgical, or acute surgical); Sequential Organ Failure Assessment score ranging from 0 to 24, with higher values indicating more severe organ failure. ¶Life support was defined as any use of mechanical ventilation (invasive ventilation, noninvasive ventilation or non-intermittent continuous positive airway pressure), circulatory support (vasopressor or inotropic infusion), or renal replacement therapy.
| Lower oxygenation group | Higher oxygenation group | Relative risk (95% CI) | Risk difference (95% CI) | Odds ratio (95% CI) | P-value | |
|---|---|---|---|---|---|---|
| Primary outcome∗ | ||||||
| 90-Day all-cause mortality, n/n-total (%) | 122/277 (44.0) | 132/285 (46.3) | ||||
| Adjusted for stratification variables† | 0.98 (0.82–1.17) | −2.59 (−10.70 to 5.51) | 0.83 | |||
| Adjusted for stratification variables† and baseline characteristics‡ | 0.92 (0.64–1.32) | 0.65 | ||||
| Secondary outcomes | ||||||
| 1-Yr all-cause mortality, n (%) | 145/277 (52.3) | 159/285 (55.8) | ||||
| Adjusted for site | 0.97 (0.83–1.13) | −3.21 (−11.35 to 4.93) | 0.67 | |||
| Median number of days alive without life support in 90 days (IQR)¶ | 78 (1–87) | 70 (0–86) | 0.24 | |||
| Mechanical ventilation | 79 (1–87) | 70 (0–87) | ||||
| Circulatory support | 83 (3–88) | 78 (3–88) | ||||
| Renal replacement therapy | 90 (7–90) | 85 (7–90) | ||||
| Median number of days alive out of hospital in 90 days (IQR) | 45 (0–74) | 36 (0–71) | 0.60 | |||
| Number of patients with one or more SAE in the ICU within 90 days, n/n-total (%) | 110/277 (39.7) | 111/285 (38.8) | 1.03 (0.84–1.26) | 0.89 (−7.16 to 8.93) | 0.77 | |
| New shock | 101 (36.5) | 106 (37.1) | ||||
| New myocardial infarction | 3 (1.1) | 1 (0.4) | ||||
| New ischemic stroke | 5 (1.8) | 5 (1.8) | ||||
| New intestinal ischemia | 8 (2.9) | 7 (2.5) |