Table 3.
Primary end point, components of the primary end point, and secondary end points (full analysis set)
| Endpoints | Arm 1, n=113 | Arm 2, n=34 | Arm 3, n=34 | Arm 4, n=116 | Arm 5, n=104 |
|---|---|---|---|---|---|
| Development of AKI using the full KDIGO definition | |||||
| Incidence, % | 77.9 | 79.4 | 76.5 | 75.9 | 74.0 |
| 95% CI | 69.1 to 85.1 | 62.1 to 91.3 | 58.8 to 89.3 | 67.0 to 83.3 | 64.5 to 82.1 |
| Odds ratioa | 1.16 | 0.97 | 0.91 | 0.84 | |
| 95% CI | 0.45 to 3.01 | 0.39 to 2.44 | 0.49 to 1.69 | 0.45 to 1.58 | |
| P valueb | 0.76 | 0.95 | 0.76 | 0.59 | |
| Increase in serum creatinine ≥0.3 mg/dl within 48 h | |||||
| Incidence, % | 53.1 | 58.8 | 55.9 | 55.2 | 51.9 |
| 95% CI | 43.5 to 62.5 | 40.7 to 75.4 | 37.9 to 72.8 | 45.7 to 64.4 | 41.9 to 61.8 |
| Odds ratio | 1.37 | 1.21 | 1.12 | 1.01 | |
| 95% CI | 0.61 to 3.06 | 0.54 to 2.68 | 0.65 to 1.92 | 0.58 to 1.74 | |
| Increase in serum creatinine ≥50% within 7 d | |||||
| Incidence, % | 20.4 | 32.4 | 23.5 | 20.7 | 22.1 |
| 95% CI | 13.4 to 29.0 | 17.4 to 50.5 | 10.7 to 41.2 | 13.7 to 29.2 | 14.6 to 31.3 |
| Odds ratio | 1.87 | 1.20 | 1.02 | 1.11 | |
| 95% CI | 0.80 to 4.38 | 0.48 to 3.00 | 0.54 to 1.94 | 0.58 to 2.13 | |
| Urine output <0.5 ml/kg per hour for ≥6 h consecutively | |||||
| Incidence, % | 60.2 | 58.8 | 55.9 | 51.7 | 61.5 |
| 95% CI | 50.5 to 69.3 | 40.7 to 75.4 | 37.9 to 72.8 | 42.3 to 61.1 | 51.5 to 70.9 |
| Odds ratio | 0.95 | 0.85 | 0.71 | 1.09 | |
| 95% CI | 0.44 to 2.08 | 0.39 to 1.84 | 0.42 to 1.20 | 0.63 to 1.89 | |
| Development of AKI using the serum creatinine–based KDIGO definition | |||||
| Incidence, % | 54.9 | 58.8 | 58.8 | 56.0 | 51.9 |
| 95% CI | 45.2 to 64.2 | 40.7 to 75.4 | 40.7 to 75.4 | 46.5 to 65.2 | 41.9 to 61.8 |
| Odds ratio | 1.26 | 1.26 | 1.07 | 0.93 | |
| 95% CI | 0.57 to 2.80 | 0.57 to 2.80 | 0.63 to 1.83 | 0.54 to 1.61 | |
| Composite of death, dialysis, or ≥30% decline in GFR at day 30 | |||||
| Incidence, % | 11.3 | 20.0 | 20.0 | 13.2 | 18.3 |
| 95% CI | 6.0 to 18.9 | 7.7 to 38.6 | 7.7 to 38.6 | 7.4 to 21.2 | 10.6 to 28.4 |
| Odds ratio | 2.00 | 2.01 | 1.19 | 1.74 | |
| 95% CI | 0.68 to 5.88 | 0.68 to 5.94 | 0.52 to 2.72 | 0.76 to 3.96 | |
| Severity of AKI,c no. (%) | |||||
| AKI stage 1 | 53 (46.9) | 15 (44.1) | 14 (41.2) | 59 (50.9) | 39 (37.5) |
| AKI stage 2 | 32 (28.3) | 10 (29.4) | 11 (32.4) | 26 (22.4) | 33 (31.7) |
| AKI stage 3 | 3 (2.7) | 5 (5.9) | 1 (2.9) | 3 (2.6) | 5 (4.8) |
| Duration of AKI within the first 7 d | |||||
| Median | 3.0 | 2.0 | 2.0 | 2.5 | 3.0 |
| Interquartile range | 1–6 | 1–5 | 1–4 | 1–7 | 2–7 |
Arm 1 indicates placebo. Arm 2 =0.02-mg/kg preoperative and postoperative doses. Arm 3 =0.12-mg/kg preoperative and 0.02-mg/kg postoperative doses. Arm 4 =0.46-mg/kg preoperative and 0.02-mg/kg postoperative doses. Arm 5 =0.46-mg/kg preoperative and postoperative doses. 95% CI, 95% confidence interval.
a
Compared with arm 1 (placebo).
b
Unadjusted P value (two sided) from logistic regression with baseline eGFR as a covariate, comparing the active arm with arm 1 (placebo).
c
Using the KDIGO classification and the full KDIGO definition of AKI.