Table 1.
Severe AKI |
||||
---|---|---|---|---|
Overall (N = 313) | Yes (N = 207) | No (N = 106) | P-value | |
Age Group at Randomization | ||||
<1 year | 151 (48%) | 110 (53%) | 41 (39%) | 0.0171 |
1–4 years | 75 (24%) | 46 (22%) | 29 (27%) | 0.3301 |
5–12 years | 48 (15%) | 28 (14%) | 20 (19%) | 0.2461 |
> 13 years | 39 (12%) | 23 (11%) | 16 (15%) | 0.3661 |
Male sex | 184 (59%) | 126 (61%) | 58 (55%) | 0.3321 |
Preexisting severe AKI (up to 2 hours after intervention initiation)2 | 150 (48%) | 150 (72%) | 0 (0%) | <.0011 |
Preexisting conditions | ||||
None | 30 (10%) | 20 (10%) | 10 (9%) | 1.0001 |
Lung or airway disease | 101 (32%) | 56 (27%) | 45 (42%) | 0.0071 |
Neurologic condition | 100 (32%) | 61 (29%) | 39 (37%) | 0.2021 |
Gastrointestinal disorder | 97 (31%) | 63 (30%) | 34 (32%) | 0.7971 |
Prenatal condition | 77 (25%) | 49 (24%) | 28 (26%) | 0.6781 |
Congenital heart disease | 173 (55%) | 119 (57%) | 54 (51%) | 0.2821 |
Cyanotic heart disease | 39 (12%) | 28 (14%) | 11 (10%) | 0.4741 |
Two ventricles | 109 (35%) | 72 (35%) | 37 (35%) | 0.3961 |
Post-operative cardiac surgery patient | 98 (31% | 81 (39%) | 17 (16%) | <.0011 |
Norwood procedure | 12 (4%) | 11 (5%) | 1 (1%) | 0.6861 |
Acquired heart disease | 51 (16%) | 37 (18%) | 14 (13%) | 0.3341 |
Arrhythmia | 65 (21%) | 51 (25%) | 14 (13%) | 0.0191 |
Immunocompromised condition or taking immunosuppressive medication | 42 (13%) | 28 (14%) | 14 (13%) | 1.0001 |
Transplant | 19 (6%) | 15 (7%) | 4 (4%) | 0.3181 |
Endocrine condition | 20 (6%) | 16 (8%) | 4 (4%) | 0.2261 |
Renal condition | 38 (12%) | 32 (15%) | 6 (6%) | 0.0111 |
Other | 138 (44%) | 92 (44%) | 46 (43%) | 0.9051 |
Primary aetiology of cardiac arrest | ||||
Cardiovascular event | 154 (49%) | 111 (54%) | 43 (41%) | 0.0321 |
Respiratory event | 99 (32%) | 54 (26%) | 45 (42%) | 0.0051 |
Congenital heart disease | 45 (14%) | 32 (15%) | 13 (12%) | 0.4991 |
Neurological event | 4 (1%) | 2 (1%) | 2 (2%) | 0.6061 |
Multiple organ system failure | 2 (1%) | 2 (1%) | 0 (0%) | 0.5511 |
Drug overdose | 2 (1%) | 1 (0%) | 1 (1%) | 1.0001 |
Electrolyte imbalance | 1 (0%) | 1 (0%) | 0 (0%) | 1.0001 |
Unknown | 6 (2%) | 4 (2%) | 2 (2%) | 1.0001 |
Initial rhythm | ||||
Asystole | 22 (7%) | 15 (7%) | 7 (7%) | 1.0001 |
Bradycardia | 179 (57%) | 118 (57%) | 61 (58%) | 1.0001 |
Pulseless electrical activity (PEA) | 66 (21%) | 43 (21%) | 23 (22%) | 0.8841 |
Ventricular fibrillation or tachycardia | 33 (11%) | 21 (10%) | 12 (11%) | 0.8461 |
Unknown | 13 (4%) | 10 (5%) | 3 (3%) | 0.5541 |
Arrest occurred at study hospital | 291 (93%) | 194 (94%) | 97 (92%) | 0.4891 |
Estimated duration of chest compressions (minutes) – Median (Q1, Q3) | 22.0 (7.0, 47.0) | 33.0 (8.0, 54.0) | 12.0 (5.0, 32.0) | <.0013 |
Total number of doses of adrenaline (epinephrine) administered – Median (Q1, Q3) | 4.0 (2.0, 8.0) | 5.0 (2.0, 9.0) | 3.0 (2.0, 6.0) | 0.0053 |
Assigned to Hypothermia treatment | 159 (51%) | 100 (48%) | 59 (56%) | 0.2341 |
ECMO at treatment initiation | 167 (53%) | 133 (64%) | 34 (32%) | <.0011 |
PRBC volume Day 0–1 per day (cc/kg) – Median (Q1, Q3) | 6.6 (0.0, 16.6) | 8.1 (0.7, 20.8) | 0.0 (0.0, 8.8) | <.0013 |
Minimum percentile of gender/height-adjusted systolic blood pressure: Median (Q1, Q3) | 1.0 (1.0, 5.0) | 1.0 (1.0, 2.0) | 2.0 (1.0, 23.0) | <.0013 |
Aminoglycoside (Day 0–1) | 27 (9%) | 17 (8%) | 10 (9%) | 0.8321 |
Vancomycin (Day 0–1) | 166 (53%) | 109 (53%) | 57 (54%) | 0.9051 |
Baseline Lactate4 (mmol/L) – Median (Q1, Q3) | 6.3 (2.5, 11.9) | 8.1 (4.0, 13.8) | 3.4 (1.8, 6.9) | <.0013 |
Peak Lactate (Day 0–1) (mmol/L) – Median (Q1, Q3) | 7.2 (3.2, 12.9) | 9.6 (4.9, 16.0) | 3.8 (2.0, 7.7) | <.0013 |
Baseline glucose concentration (mmol/L) – Median (Q1, Q3) | 186 (116, 276) | 177 (106, 274) | 191 (125, 278) | 0.3433 |
Baseline ALT concentration (U/L) – Median (Q1, Q3) | 49 (25, 146) | 55 (28, 161) | 36 (23, 93) | 0.0143 |
Peak ALT (Day 0–5) concentration (U/L) – Median (Q1, Q3) | 95 (42, 300) | 134 (53, 438) | 67 (36, 136) | <.0013 |
Milrinone (Day 0–1) | 155 (50%) | 112 (54%) | 43 (41%) | 0.0311 |
Vasopressin (Day 0–1) | 56 (18%) | 45 (22%) | 11 (10%) | 0.0131 |
Vasoactive Agents (Day 0–1) | ||||
Adrenaline | 189 (60%) | 136 (66%) | 53 (50%) | 0.0101 |
Dopamine | 110 (35%) | 84 (41%) | 26 (25%) | 0.0061 |
Noradrenaline (Norepinephrine) | 40 (13%) | 30 (14%) | 10 (9%) | 0.2831 |
Dobutamine | 22 (7%) | 16 (8%) | 6 (6%) | 0.6421 |
Phenylephrine | 9 (3%) | 3 (1%) | 6 (6%) | 0.0661 |
Number of Vasoactive Agents (Day 0–1) | 0.0181 | |||
0 | 85 (27%) | 49 (24%) | 36 (34%) | |
1 | 112 (36%) | 68 (33%) | 44 (42%) | |
2 | 93 (30%) | 72 (35%) | 21 (20%) | |
3 | 93 (30%) | 15 (7%) | 5 (5%) | |
4 | 3 (1%) | 3 (1%) | 0 (0%) |
P-value is based on Fisher’s exact test.
Preexisting severe AKI status was unknown for 25 (8%) subjects.
P-value is based on the Wilcoxon rank-sum test.
First non-missing lactate value occurring = 8 hours after randomization.