Feature | STARRT-AKI (pilot) [6] | ELAIN [2] | AKIKI [1] | IDEAL-ICU [7] | STARRT-AKI (main) |
---|---|---|---|---|---|
Country | Canada | Germany | France | France | Multiple |
Number of sites | 12 | 1 | 31 | 24 | >60 |
Number of participants | 100 | 231 | 620 | 864a | 2866a |
Setting/population | Mixed medical/surgical ICU | Mixed medical/surgical ICU (94.8 % surgical) | Mixed medical/surgical ICU (79.7 % medical) | Mixed medical/surgical ICU (septic shock) | Mixed medical/surgical ICU |
ARR for sample size calculation | N/A | 18 % | 15 % | 10 % | 6 % |
Control group mortality | N/A | 55 % | 55 % | 55 % | 40 % |
Interventions | |||||
Early | Two of: (i) 2× increase in SCr from baseline; (ii) UOP < 6 ml/kg in preceding 12 hours; (iii) blood NGAL ≥ 400 ng/ml (within 12 hours) | KDIGO stage 2 (within 8 hours) | KDIGO stage 3 (within 6 hours) | KDIGO stage 3b (within 12 hours) | KDIGO stage 2 (within 12 hours) |
Delayed (conservative) | Specific criteria/emergent indications (beyond 12 hours) | KDIGO stage 3 (within 12 hours) | Specific criteria/emergent indications | Specific criteria 48–60 hours after eligibility or emergent indications | Specific criteria/emergent indications (beyond 12 hours) |
Time difference | 41.6 hoursc | 25.5 hours | 57.0 hours | N/A | N/A |
Received RRT in delayed intervention | 75.0 % | 90.8 % | 51.0 % | N/A | N/A |
RRT modality | Physician discretion | CRRT | Physician discretion (initial IHD 55 %) | Physician discretion | Physician discretion |
Sepsis (%) | 56 % | N/A | 67 % | N/A | N/A |
SOFA score of enrolled patients | ~13.0 | ~16.0 | ~10.9 | N/A | N/A |
Mechanical ventilation (%) | 93 % | 88 % | 87 % | N/A | N/A |
Vasopressors (%) | 85 % | 88 % | 85 % | N/A | N/A |
Primary endpoint | 90-day mortality | 90-day mortality | 60-day mortality | 90-day mortality | 90-day mortality |
Early | 38 % | 39.3 % | 48.5 % | N/A | N/A |
Delayed | 37 % | 54.7 % | 49.7 % | N/A | N/A |