Ā | Phenotype 1 | Phenotype 2 | ||||
---|---|---|---|---|---|---|
Ilofotase alfa (nā=ā164) | Placebo (nā=ā166) | p value | Ilofotase alfa (nā=ā122) | Placebo (nā=ā118) | p value | |
Age (years) | 71.00 [64.00, 76.00] | 70.00 [61.00, 76.75] | Ā | 69.00 [61.25, 76.00] | 69.50 [60.00, 77.00] | Ā |
BMI | 29.19 [24.41, 33.46] | 27.26 [25.13, 34.92] | Ā | 28.55 [25.38, 32.69] | 26.96 [24.57, 32.54] | Ā |
Sex (% males) | 105 (64.0%) | 110 (66.3%) | Ā | 73 (59.8%) | 70 (59.3%) | Ā |
Pre-AKI eGFR (mL/min/1.73 m2) | 74.08 [59.77, 90.22] | 74.98 [64.29, 89.96] | Ā | 74.87 [61.59, 87.22] | 72.13 [53.99, 86.86] | Ā |
APACHE II score | 19.50 [16.00, 25.00] | 21.00 [17.00, 24.25] | Ā | 27.00 [22.00, 32.00] | 26.00 [22.00, 30.75] | Ā |
mSOFA score | 8.00 [7.00, 10.00] | 8.00 [7.00, 10.00] | Ā | 9.00 [8.00, 11.00] | 10.00 [9.00, 12.00] | ** |
Bicarbonate (mmol/L) | 22.00 [19.62, 24.60] | 22.00 [20.00, 24.90] | Ā | 17.05 [15.00, 19.00] | 18.00 [16.00, 20.00] | Ā |
Hematocrit (%) | 32.60 [28.70, 37.00] | 33.00 [27.08, 38.15] | Ā | 35.95 [30.00, 40.62] | 34.30 [29.55, 39.05] | Ā |
Lactate (mmol/L) | 1.70 [1.10, 2.15] | 1.70 [1.20, 2.48] | Ā | 3.90 [2.60, 5.40] | 4.25 [3.00, 6.62] | Ā |
MAKE90 (%) | 81 (49.4%) | 76 (45.8%) | Ā | 66 (54.1%) | 80 (67.8%) | * |
ā>ā25% drop in eGFR at day 90 compared with pre-AKI reference-eGFR | 12 (7.3%) | 17 (10.2%) | Ā | 7 ( 5.7%) | 8 ( 6.8%) | Ā |
On RRT at day 90 OR on RRT through day28 (%) | 35 (21.3%) | 38 (22.9%) | Ā | 42 (34.4%) | 57 (48.3%) | * |
28-day in-hospital mortality (%) | 39 (23.8%) | 31 (18.7%) | Ā | 39 (32.0%) | 42 (35.6%) | Ā |
90-day in-hospital mortality (%) | 51 (31.1%) | 43 (25.9%) | Ā | 46 (37.7%) | 51 (43.2%) | Ā |