Table 1.
Incidence of acute kidney injury in POISE-2 and associated statistical power to detect an intervention effect
| All patients (n=4880)* | Patients with a preoperative eGFR >60 mL/min/1.73 m2 (n=3690) | Patients with a preoperative eGFR ≤60 mL/min/1.73 m2 (n=1190) | Statistical power to detect a 20% relative risk reduction (6500 patients) | |
|---|---|---|---|---|
| AKI (primary definition) | 580 (11.9%) | 398 (10.8%) | 182 (15.3%) | 88% |
| Alternate definitions | ||||
| AKI or death | 583 (12.0%) | 399 (10.8%) | 184 (15.5%) | 88% |
| AKI for at least 2 days | 309 (6.3%) | 190 (5.2%) | 119 (10.0%) | 57% |
| Stage 2 AKI or more | 138 (2.8%) | 97 (2.6%) | 41 (3.5%) | 32% |
*Number of POISE-2 AKI substudy patients randomised as of April 2013. By December 2013, we expect over 6500 patients will be enrolled into the study.
Two-tailed α=0.05, χ2 test, assumes that the incidence observed in all patients (n=4880) will be the incidence observed in the placebo group.
AKI, acute kidney injury; eGFR, estimated-glomerular filtration rate, POISE-2, Perioperative Ischaemic Evaluation-2.