Table 1.
Baseline characteristics, interventions, and mortality
| Randomised group | Total (n = 3141) | |||
|---|---|---|---|---|
| Albumin bolus (n = 1050) | Saline bolus (n = 1047) | Control (no bolus) (n = 1044) | ||
| Baseline characteristics | ||||
| Age (median (IQR) months) | 23 (14, 37) | 23 (13, 37) | 25 (14, 40) | 24 (13, 38) |
| Female sex | 474 (45%) | 480 (46%) | 498 (48%) | 1452 (46%) |
| Malariaa | 590 (57%) | 612 (59%) | 593 (57%) | 1795 (57%) |
| Impaired consciousnessb | 811 (77%) | 828 (79%) | 759 (73%) | 2398 (76%) |
| Respiratory distress | 874 (83%) | 854 (82%) | 857 (83%) | 2585 (83%) |
| Impaired perfusion | ||||
| Capillary refill > 2 s | 263 (25%) | 299 (29%) | 257 (25%) | 819 (26%) |
| Lower limb temperature gradientc | 620 (59%) | 629 (61%) | 610 (58%) | 1859 (59%) |
| Weak radial pulse | 210 (20%) | 239 (23%) | 206 (19%) | 655 (21%) |
| Severe tachycardiad | 736 (70%) | 721 (69%) | 738 (71%) | 2195 (70%) |
| Interventions | ||||
| One or more boluses received | 1045 (99%) | 1041 (99%) | 1 (< 1%) | 2087 (67%) |
| Two or more boluses received | 318 (30%) | 306 (29%) | 6 (< 1%) | 630 (20%) |
| Mortality | ||||
| Deaths by 48 h | 111 (11%) | 110 (11%) | 76 (7%) | 297 (9%) |
| Deaths by 28 days | 128 (12%) | 126 (12%) | 91 (9%) | 345 (11%) |
| Cardiogenic deaths | 56 (5%) | 51 (5%) | 29 (3%) | 137 (4%) |
| Neurological deaths | 33 (3%) | 33 (3%) | 36 (3%) | 102 (3%) |
| Respiratory deaths | 27 (3%) | 29 (3%) | 16 (2%) | 72 (2%) |
| Unknown/other TCE | 12 (1%) | 12 (1%) | 10 (1%) | 34 (1%) |
| Median time to death (hours) (IQR)e | 10.4 (2.8, 26.5) | 8.1 (2.9, 21.8) | 7.8 (1.8, 27.0) | 8.5 (2.5, 23.8) |
aPositive for malaria parasitaemia on either a rapid diagnostic test or a microscopy slide
bImpaired consciousness was defined as prostration or coma. Prostration: the inability of a child older than 8 months of age to sit upright or the inability of a child 8 months of age or younger to breast-feed. Coma: the inability to localise a painful stimulus)
cLower limb temperature gradient, defined as a notable temperature change from cold (dorsum of foot) to warm (knee) when running the back of hand from the toe to the knee
dWeak pulse: weak radial pulse or severe tachycardia, defined as heart rate > 180 beats per minute (bpm) for children < 1 year old, > 160 bpm for those 1 to 4 years old, and > 140 bpm for those ≥ 5 years old)
eMedian test p = 0.53 comparing the two bolus groups