Table 3.
Main results for analysis of primary, safety, and secondary outcomes. Values are number (percentage) unless stated otherwise
| No included in analysis | Summary measure | Fully adjusted prespecified primary analysis model | Minimally adjusted analysis model (post hoc)* | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention (n=1251) | Usual Care (n=1247) | Intervention | Usual Care | Adjusted odds ratio (95% CI) | P value | Adjusted difference in percentage points (95% CI) | Adjusted odds ratio (95% CI) | P value | Adjusted difference in percentage points (95% CI) | ||||
| Postoperative infection <30 days of randomisation (primary outcome) | 1247 (99.7) | 1247 (100) | 289 (23.2) | 283 (22.7) | 1.03 (0.84 to 1.25) | 0.81 | 0.4 (−3.4 to 4.2) | 1.03 (0.85 to 1.25) | 0.75 | 0.5 (−3.3 to 4.3) | |||
| Acute cardiac event <24 hours of randomisation (safety outcome) | 1250 (99.9) | 1247 (100) | 38 (3.0) | 21 (1.7) | 1.82 (1.06 to 3.13) | 0.03 | 1.3 (0.1 to 2.5) | 1.84 (1.07 to 3.17) | 0.03 | 1.4 (0.0 to 2.7) | |||
| Acute cardiac event <30 days of randomisation (safety outcome) | 1249 (99.8) | 1247 (100) | 85 (6.8) | 79 (6.3) | 1.06 (0.77 to 1.47) | 0.71 | 0.4 (−1.6 to 2.3) | 1.09 (0.79 to 1.50) | 0.61 | 0.5 (−1.4 to 2.4) | |||
| Acute kidney injury <30 days of randomisation | 1250 (99.9) | 1247 (100) | 40 (3.2) | 32 (2.6) | 1.24 (0.77 to 2.00) | 0.37 | 0.6 (−1.1 to 2.3) | 1.26 (0.78 to 2.02) | 0.35 | 0.6 (−1.1 to 2.3) | |||
| Mortality <180 days of randomisation | 1241 (99.2) | 1239 (99.4) | 68 (5.4) | 84 (6.7) | 0.76 (0.54 to 1.07) | 0.12 | −1.5 (−3.5 to 0.5) | 0.79 (0.56 to 1.11) | 0.17 | −1.3 (−3.1 to 0.6) | |||
ASA=American Society of Anesthesiologists.
*
Adjusted for minimisation factors: country, surgical procedure, and ASA class only.