Table 3.

Primary end point, components of the primary end point, and secondary end points (full analysis set)

EndpointsArm 1, n=113Arm 2, n=34Arm 3, n=34Arm 4, n=116Arm 5, n=104
Development of AKI using the full KDIGO definition
 Incidence, %77.979.476.575.974.0
 95% CI69.1 to 85.162.1 to 91.358.8 to 89.367.0 to 83.364.5 to 82.1
 Odds ratioa1.160.970.910.84
 95% CI0.45 to 3.010.39 to 2.440.49 to 1.690.45 to 1.58
P valueb0.760.950.760.59
Increase in serum creatinine ≥0.3 mg/dl within 48 h
 Incidence, %53.158.855.955.251.9
 95% CI43.5 to 62.540.7 to 75.437.9 to 72.845.7 to 64.441.9 to 61.8
 Odds ratio1.371.211.121.01
 95% CI0.61 to 3.060.54 to 2.680.65 to 1.920.58 to 1.74
Increase in serum creatinine ≥50% within 7 d
 Incidence, %20.432.423.520.722.1
 95% CI13.4 to 29.017.4 to 50.510.7 to 41.213.7 to 29.214.6 to 31.3
 Odds ratio1.871.201.021.11
 95% CI0.80 to 4.380.48 to 3.000.54 to 1.940.58 to 2.13
Urine output <0.5 ml/kg per hour for ≥6 h consecutively
 Incidence, %60.258.855.951.761.5
 95% CI50.5 to 69.340.7 to 75.437.9 to 72.842.3 to 61.151.5 to 70.9
 Odds ratio0.950.850.711.09
 95% CI0.44 to 2.080.39 to 1.840.42 to 1.200.63 to 1.89
Development of AKI using the serum creatinine–based KDIGO definition
 Incidence, %54.958.858.856.051.9
 95% CI45.2 to 64.240.7 to 75.440.7 to 75.446.5 to 65.241.9 to 61.8
 Odds ratio1.261.261.070.93
 95% CI0.57 to 2.800.57 to 2.800.63 to 1.830.54 to 1.61
Composite of death, dialysis, or ≥30% decline in GFR at day 30
 Incidence, %11.320.020.013.218.3
 95% CI6.0 to 18.97.7 to 38.67.7 to 38.67.4 to 21.210.6 to 28.4
 Odds ratio2.002.011.191.74
 95% CI0.68 to 5.880.68 to 5.940.52 to 2.720.76 to 3.96
Severity of AKI,c no. (%)
 AKI stage 153 (46.9)15 (44.1)14 (41.2)59 (50.9)39 (37.5)
 AKI stage 232 (28.3)10 (29.4)11 (32.4)26 (22.4)33 (31.7)
 AKI stage 33 (2.7)5 (5.9)1 (2.9)3 (2.6)5 (4.8)
Duration of AKI within the first 7 d
 Median3.02.02.02.53.0
 Interquartile range1–61–51–41–72–7
  • 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.