Table 1.
Baseline characteristics.
| n | All | Metoclopramide |
Ceftriaxone |
Paracetamol |
||||
|---|---|---|---|---|---|---|---|---|
| Yes | None | Yes | None | Yes | None | |||
| Patients randomised | 1492a | 704 | 708 | 593 | 482 | 706 | 738 | |
| Age | 1492 | 79.7 (7.7) | 79.7 (7.8) | 79.6 (7.8) | 79.6 (8.1) | 79.6 (7.8) | 79.7 (7.7) | 79.9 (7.7) |
| Sex, male (%) | 1492 | 751 (50.3) | 345 (49) | 368 (52) | 308 (51.9) | 229 (47.5) | 355 (50.3) | 368 (49.9) |
| Pre-stroke mRS, median [IQR] | 1490 | 0 [0,2] | 0 [0,2] | 0 [0,2] | 0 [0,2] | 0 [0,2] | 0 [0,2] | 0 [0,2] |
| Ethnicity, White (%) | 1490 | 1435 (96.3) | 677 (96.3) | 680 (96.2) | 575 (97.1) | 474 (98.5) | 672 (95.2) | 717 (97.4) |
| Medical history (%) | ||||||||
| Atrial fibrillation (%) | 1490 | 441 (29.6) | 199 (28.3) | 208 (29.4) | 168 (28.4) | 152 (31.6) | 220 (31.2) | 210 (28.5) |
| Hypercholesterolaemia (%) | 1490 | 528 (35.4) | 250 (35.6) | 253 (35.8) | 214 (36.1) | 175 (36.4) | 266 (37.7) | 251 (34.1) |
| Hypertension (%) | 1490 | 1084 (72.8) | 514 (73.1) | 515 (72.8) | 431 (72.8) | 375 (78) | 500 (70.8) | 549 (74.6) |
| Diabetes mellitus (%) | 1492 | 321 (21.5) | 159 (22.6) | 146 (20.6) | 131 (22.1) | 113 (23.4) | 157 (22.2) | 152 (20.6) |
| Obstructive pulmonary disease (%) | 1490 | 114 (7.7) | 68 (9.7) | 41 (5.8) | 51 (8.6) | 34 (7.1) | 45 (6.4) | 67 (9.1) |
| Previous stroke (%) | 1490 | 294 (19.7) | 139 (19.8) | 137 (19.4) | 116 (19.6) | 97 (20.2) | 141 (20) | 137 (18.6) |
| Immunocompromised (%) | 1490 | 15 (1) | 9 (1.3) | 6 (0.8) | 6 (1) | 5 (1) | 6 (0.8) | 8 (1.1) |
| Smoking status (%) | ||||||||
| Current | 1492 | 152 (10.2) | 72 (10.2) | 74 (10.5) | 79 (13.3) | 47 (9.8) | 68 (9.6) | 76 (10.3) |
| Ever | 1492 | 343 (23) | 167 (23.7) | 160 (22.6) | 119 (20.1) | 98 (20.3) | 165 (23.4) | 166 (22.5) |
| Never/unknown | 1492 | 997 (66.8) | 465 (66.1) | 474 (66.9) | 395 (66.6) | 337 (69.9) | 473 (67) | 496 (67.2) |
| Pre-stroke feeding status (%) | . | |||||||
| Normal | 1490 | 1482 (99.5) | 699 (99.4) | 704 (99.6) | 588 (99.3) | 480 (99.8) | 704 (99.7) | 731 (99.3) |
| Oral softened food or fluids only | 1490 | 8 (0.5) | 4 (0.6) | 3 (0.4) | 4 (0.7) | 1 (0.2) | 2 (0.3) | 5 (0.7) |
| Nasogastric tube | 1490 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Percutaneous endoscopic gastrostomy (PEG) | 1490 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Intravenous only | 1490 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Use of drugs 3 days before randomisation (%) | ||||||||
| Antipyretic inc. paracetamol | 1490 | 129 (8.7) | 67 (9.5) | 57 (8.1) | 42 (7.1) | 40 (8.3) | 66 (9.3) | 56 (7.6) |
| Antiemetic inc. metoclopramide | 1490 | 59 (4) | 34 (4.8) | 23 (3.3) | 20 (3.4) | 14 (2.9) | 32 (4.5) | 26 (3.5) |
| Antibiotics inc. ceftriaxone | 1490 | 19 (1.3) | 10 (1.4) | 9 (1.3) | 5 (0.8) | 5 (1) | 9 (1.3) | 10 (1.4) |
| Time from onset to randomisation (hours) | 1490 | 14.6 [7.8, 20.5] | 14.8 [7.6, 20.4] | 14.4 [7.8, 20.8] | 13.4 [7.5, 19.9] | 14.3 [8.6, 20.5] | 14.8 [7.8, 20.7] | 14.5 [7.7, 20.3] |
| Stroke type (%) | ||||||||
| Ischaemic stroke | 1488 | 1263 (84.9) | 590 (84) | 608 (86) | 509 (86.3) | 420 (87.3) | 582 (82.4) | 644 (87.7) |
| Intracerebral haemorrhage | 1488 | 204 (13.7) | 99 (14.1) | 95 (13.4) | 75 (12.7) | 53 (11) | 113 (16) | 80 (10.9) |
| Other diagnosis | 1488 | 21 (1.4) | 13 (1.9) | 4 (0.6) | 6 (1) | 8 (1.7) | 11 (1.6) | 10 (1.4) |
| NIHSS total score (/42) | 1492 | 12 [8,17] | 11 [8,17] | 12 [8,17] | 11 [8,17] | 11 [8,16] | 12 [8,17] | 12 [8,17] |
| Systolic blood pressure (mmHg) | 1483 | 152.8 (26) | 153.4 (25.6) | 152.2 (26.3) | 151 (25.7) | 151.9 (26.3) | 151.7 (26.4) | 153.8 (25.5) |
| Diastolic blood pressure (mmHg)) | 1483 | 80.6 (16.8) | 81 (17.1) | 80.5 (16.5) | 79.5 (16.6) | 80.3 (17) | 80.5 (16.7) | 80.6 (16.7) |
| Heart rate (bpm) | 1470 | 78.1 (17.8) | 78.3 (18.4) | 77.7 (17.2) | 77.6 (17.5) | 79.1 (18) | 78 (18) | 77.8 (17.7) |
| Temperature (°C) | 1380 | 36.5 (0.5) | 36.5 (0.5) | 36.5 (0.5) | 36.5 (0.5) | 36.5 (0.6) | 36.5 (0.5) | 36.5 (0.5) |
| Acute stroke treatment (%) | ||||||||
| Intravenous thrombolysis | 1282 | 598 (46.6) | 281 (46.8) | 287 (46.9) | 253 (49.2) | 193 (45.1) | 282 (47.6) | 295 (45.2) |
| Mechanical thrombectomy | 1282 | 305 (23.8) | 149 (24.8) | 133 (21.7) | 149 (29) | 107 (25) | 138 (23.3) | 161 (24.7) |
Data are n (%), mean (SD) or median [IQR].
inc indicates including; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke scale; BP, blood pressure.
a
Note that the Medical Ethics Committee of UMC Utrecht did not allow to use any data of the patient whose consent form was lost.