Table 4.
Severe AKI |
||||
---|---|---|---|---|
Overall (N = 204) | Yes (N = 146) | No (N = 58) | P-value | |
Age Group at Randomization | ||||
<1 year | 117 (57%) | 90 (62%) | 27 (47%) | 0.0601 |
1–4 years | 52 (25%) | 32 (22%) | 20 (34%) | 0.0751 |
5–12 years | 22 (11%) | 13 (9%) | 9 (16%) | 0.2101 |
> 13 years | 13 (6%) | 11 (8%) | 2 (3%) | 0.3571 |
Male sex | 124 (61%) | 90 (62%) | 34 (59%) | 0.7511 |
Preexisting severe AKI (up to 2 hours after intervention initiation)2 | 114 (56%) | 114 (78%) | 0 (0%) | <.0011 |
Preexisting conditions | ||||
Lung or airway disease | 56 (27%) | 36 (25%) | 20 (34%) | 0.1671 |
Neurologic condition | 64 (31%) | 43 (29%) | 21 (36%) | 0.4041 |
Gastrointestinal disorder | 72 (35%) | 51 (35%) | 21 (36%) | 0.8721 |
Prenatal condition | 56 (27%) | 38 (26%) | 18 (31%) | 0.4901 |
Congenital heart disease | 173 (85%) | 119 (82%) | 54 (93%) | 0.0501 |
Cyanotic heart disease | 39 (19%) | 28 (19%) | 11 (19%) | 1.0001 |
Two ventricles | 109 (53%) | 72 (49%) | 37 (64%) | 0.3961 |
Post-operative cardiac surgery patient | 98 (48%) | 81 (55%) | 17 (29%) | 0.0011 |
Norwood procedure | 12 (6%) | 11 (8%) | 1 (2%) | 0.6861 |
Acquired heart disease | 51 (25%) | 37 (25%) | 14 (24%) | 1.0001 |
Other | 164 (80%) | 119 (82%) | 45 (78%) | 0.5601 |
Primary aetiology of cardiac arrest | ||||
Cardiac | 158 (77%) | 117 (80%) | 41 (71%) | 0.1931 |
ALTE/SUID | 1 (0%) | 0 (0%) | 1 (2%) | 0.2841 |
Other Respiratory | 41 (20%) | 25 (17%) | 16 (28%) | 0.1201 |
Other/Unknown | 4 (2%) | 4 (3%) | 0 (0%) | 0.5791 |
Initial rhythm noted | ||||
Asystole | 8 (4%) | 7 (5%) | 1 (2%) | 0.4451 |
Bradycardia | 125 (61%) | 89 (61%) | 36 (62%) | 1.0001 |
Pulseless electrical activity (PEA) | 45 (22%) | 30 (21%) | 15 (26%) | 0.4551 |
Ventricular fibrillation or tachycardia | 20 (10%) | 15 (10%) | 5 (9%) | 0.8011 |
Unknown | 6 (3%) | 5 (3%) | 1 (2%) | 0.6771 |
Estimated duration of chest compressions (minutes) – Median (Q1, Q3) | 30.0 (8.0, 52.5) | 36.0 (13.0, 55.0) | 12.0 (4.0, 33.0) | <.0013 |
Total number of doses of adrenaline administered – Median (Q1, Q3) | 4.0 (2.0, 9.0) | 5.0 (3.0, 9.0) | 3.0 (2.0, 7.0) | 0.0063 |
Assigned to Hypothermia treatment | 107 (52%) | 72 (49%) | 35 (60%) | 0.1651 |
ECMO at treatment initiation | 130 (64%) | 106 (73%) | 24 (41%) | <.0011 |
PRBC volume Day 0–1 per day (cc/kg) – Median (Q1, Q3) | 7.5 (0.0, 19.8) | 9.7 (4.9, 26.4) | 0.0 (0.0, 10.0) | <.0013 |
Minimum percentile of gender/height-adjusted systolic blood pressure: Median (Q1, Q3) | 1.0 (1.0, 4.0) | 1.0 (1.0, 2.0) | 4.0 (1.0, 26.0) | <.0013 |
Aminoglycoside (Day 0–1) | 19 (9%) | 13 (9%) | 6 (10%) | 0.7921 |
Vancomycin (Day 0–1) | 104 (51%) | 77 (53%) | 27 (47%) | 0.4391 |
Baseline Lactate4 (mmol/L) – Median (Q1, Q3) | 6.6 (2.5, 12.7) | 8.8 (4.2, 14.3) | 3.3 (1.7, 7.2) | <.0013 |
Peak Lactate (Day 0–1) (mmol/L) – Median (Q1, Q3) | 7.7 (3.6, 13.7) | 10.5 (5.1, 16.0) | 3.5 (2.0, 7.9) | <.0013 |
Baseline glucose concentration (mmol/L) – Median (Q1, Q3) | 180 (119, 243) | 194 (115, 263) | 175 (123, 227) | 0.7863 |
Baseline ALT concentration (U/L) – Median (Q1, Q3) | 45 (25, 156) | 52 (28, 165) | 32 (21, 89) | 0.0263 |
Peak ALT (Day 0–5) concentration (U/L) – Median (Q1, Q3) | 83 (40, 296) | 117 (49, 500) | 41 (31, 125) | <.0013 |
Milrinone (Day 0–1) | 128 (63%) | 94 (64%) | 34 (59%) | 0.5211 |
Vasopressin (Day 0–1) | 35 (17%) | 28 (19%) | 7 (12%) | 0.3041 |
Vasoactive Agents (Day 0–1) | ||||
Adrenaline | 126 (62%) | 96 (66%) | 30 (52%) | 0.0791 |
Dopamine | 67 (33%) | 58 (40%) | 9 (16%) | <.0011 |
Noradrenaline | 18 (9%) | 15 (10%) | 3 (5%) | 0.2891 |
Dobutamine | 18 (9%) | 12 (8%) | 6 (10%) | 0.5961 |
Phenylephrine | 7 (3%) | 2 (1%) | 5 (9%) | 0.0211 |
Number of Vasoactive Agents (Day 0–1) | 0.1371 | |||
0 | 55 (27%) | 35 (24%) | 20 (34%) | |
1 | 76 (37%) | 51 (35%) | 25 (43%) | |
2 | 60 (29%) | 49 (34%) | 11 (19%) | |
3 | 12 (6%) | 10 (7%) | 2 (3%) | |
4 | 1 (0%) | 1 (1%) | 0 (0%) |
P-value is based on Fisher’s exact test.
Preexisting severe AKI status was unknown for 16 (8%) subjects.
P-value is based on the Wilcoxon rank-sum test.
First non-missing lactate value occurring = 8 hours after randomization.