Table 3.
Early secondary outcomes and treatment restrictions.
| N | Metoclopramide |
Ceftriaxone |
Paracetamol |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Yes | None | DIM/OR (95% CI) | p | Yes | None | DIM/OR (95% CI) | p | Yes | None | DIM/OR (95% CI) | p | ||
| 24 h | |||||||||||||
| Body temperature °C | 1258 | 36.8 (0.6) | 36.7 (0.6) | 0.02 (−0.05, 0.08) | 0.61 | 36.8 (0.6) | 36.8 (0.6) | −0.00 (−0.08, 0.07) | 0.96 | 36.7 (0.5) | 36.8 (0.6) | −0.12 (−0.19, −0.06) | <0.001 |
| Temperature ≥ 38 °C (%) | 1258 | 19 (3.2) | 20 (3.3) | 0.99 (0.44, 2.25) | 0.98 | 18 (3.6) | 15 (3.7) | 0.95 (0.38, 2.35) | 0.91 | 7 (1.2) | 30 (4.8) | 0.32 (0.13, 0.78) | 0.012 |
| Day 7 | |||||||||||||
| mRS | |||||||||||||
| All patients | 1482 | 4 [3,5] | 4 [3,5] | 0.88 (0.71, 1.10) | 0.27 | 4 [3,5] | 4 [3,5] | 0.89 (0.69, 1.15) | 0.38 | 4 [3,5] | 4 [3,5] | 1.05 (0.84, 1.30) | 0.68 |
| Ischaemic stroke | 1259 | 4 [3,5] | 4 [3,5] | 0.88 (0.71, 1.10) | 0.26 | 4 [3,5] | 4 [3,5] | 0.87 (0.67, 1.12) | 0.28 | 4 [3,5] | 4 [3,5] | 1.06 (0.85, 1.31) | 0.63 |
| Intracerebral haemorrhage | 203 | 4 [4,5] | 5 [4,5] | 0.86 (0.48, 1.53) | 0.61 | 5 [4,5] | 4 [4,5] | 1.73 (0.80, 3.74) | 0.16 | 5 [4,5] | 5 [4,5] | 0.77 (0.43, 1.37) | 0.37 |
| Death at 7 days (%) | 1482 | 46 (6.6) | 42 (6) | 1.07 (0.62, 1.84) | 0.81 | 34 (5.8) | 29 (6) | 0.77 (0.40, 1.46) | 0.42 | 44 (6.3) | 45 (6.1) | 1.11 (0.65, 1.90) | 0.69 |
| Infection (number of participants), clinical diagnosis | |||||||||||||
| Any infection (%) | 1482 | 199 (28.5) | 175 (24.8) | 1.20 (0.90, 1.60) | 0.22 | 129 (21.9) | 159 (33.1) | 0.55 (0.39, 0.78) | <0.001 | 177 (25.2) | 207 (28.3) | 0.79 (0.60, 1.05) | 0.11 |
| Pneumonia (%) | 1482 | 138 (19.8) | 111 (15.7) | 1.38 (0.98, 1.95) | 0.063 | 102 (17.3) | 89 (18.5) | 0.77 (0.52, 1.15) | 0.21 | 121 (17.2) | 134 (18.3) | 0.84 (0.60, 1.17) | 0.31 |
| Urinary tract infection (%) | 1482 | 52 (7.4) | 48 (6.8) | 1.00 (0.60, 1.65) | 1.00 | 12 (2) | 59 (12.3) | 0.21 (0.11, 0.44) | <0.001 | 41 (5.8) | 64 (8.7) | 0.53 (0.31, 0.88) | 0.015 |
| Other infections (%) | 1482 | 24 (3.4) | 26 (3.7) | 0.89 (0.47, 1.68) | 0.71 | 20 (3.4) | 20 (4.2) | 0.85 (0.40, 1.79) | 0.66 | 25 (3.6) | 25 (3.4) | 1.32 (0.70, 2.49) | 0.39 |
| Infection (number of participants), panel adjudicated | |||||||||||||
| All any infection (%) | 1487 | 71 (10.1) | 61 (8.6) | 1.07 (0.70, 1.64) | 0.74 | 54 (9.2) | 55 (11.4) | 0.76 (0.48, 1.23) | 0.27 | 60 (8.5) | 80 (10.9) | 0.72 (0.48, 1.09) | 0.12 |
| Pneumonia (%) | 1487 | 46 (6.6) | 35 (5) | 1.27 (0.76, 2.14) | 0.36 | 41 (6.9) | 29 (6) | 0.96 (0.54, 1.69) | 0.88 | 40 (5.7) | 48 (6.5) | 0.79 (0.48, 1.32) | 0.37 |
| Urinary tract infection (%) | 1487 | 19 (2.7) | 21 (3) | 0.67 (0.31, 1.44) | 0.31 | 6 (1) | 21 (4.4) | 0.35 (0.13, 0.95) | 0.039 | 16 (2.3) | 24 (3.3) | 0.63 (0.29, 1.35) | 0.24 |
| Other infections (%) | 1487 | 7 (1) | 7 (1) | 1.24 (0.36, 4.27) | 0.73 | 7 (1.2) | 5 (1) | 1.33 (0.30, 5.94) | 0.71 | 5 (0.7) | 10 (1.4) | 0.68 (0.19, 2.40) | 0.55 |
mRS, modified Rankin Scale. Data are n (%), mean (SD) or median [IQR]. Treatments effects are adjusted for stratification (country), minimisation (age, sex, stroke type, stroke severity, diabetes), and other baseline prognostic factors (e.g. pre-morbid mRS, atrial fibrillation, reperfusion treatment [alteplase and/or thrombectomy], time from onset to randomisation), and treatment allocation to the other two strata of the trial, unless otherwise stated. aOR: adjusted odds ratio, aDIM: adjusted difference in means. Comparison by adjusted ordinal logistic regression (aOLR), binary logistic regression (aBLR) or multiple linear regression (aMLR).