In a multi-centre, open-label, randomised, controlled trial (NCT00497328), we prospectively enrolled 548 patients with at least moderate renal impairment undergoing cardiac catheterisation with or without percutaneous coronary intervention. Patients were randomly assigned to 3 groups: 1) NAC: 154 mEq/L sustained sodium chloride regime (1 mL/kg/h 12 h before, during and 6 h after the procedure) with oral NAC at 1.2 g bid for 3 days (n = 185); 2) SOB: 154 mEq/L abbreviated SOB regime at 3 mL/kg/h 1 h before the procedure, and 1 mL/kg/h during and 6 h after the procedure (n = 182); and 3) COM: combination of abbreviated SOB regime and oral NAC (n = 181). The primary end point was incidence of CIN. The secondary end points were rise in serum creatinine, hospitalisation duration, haemodialysis, morbidity and mortality within 30 days.
The 3 groups had similar baseline characteristics: age 68 ± 10 years, 76% male, 48% diabetic and baseline glomerular filtration rate (GFR) 47.7 ± 13.0 mL/min. There were 41 (8.8%) patients with GFR < 30. The CIN incidences were NAC 6.5%, SOB 12.8% and COM 10.6%. The COM regimen was not superior to either the NAC (relative risk (RR) = 1.61, 95% confidence interval (CI): 0.76 to 3.45, p = 0.225) or SOB (RR = 0.83, 95% CI: 0.44 to 1.56, p = 0.593) regimens. The CIN incidence was lower in the NAC group than the SOB group (adjusted odds ratio (OR) = 0.40, 95% CI: 0.17 to 0.92; p = 0.032). Multivariate analysis showed contrast volume (OR = 1.99, 95% CI: 1.33 to 2.96, p < 0.001 per 100 mL), female (OR = 2.47, 95% CI: 1.22 to 5.00, p = 0.012) and diabetes (OR = 2.03, 95% CI: 1.03 to 3.99, p = 0.041) were independent risk predictors. There were no differences in the secondary outcomes among the 3 groups.
The combination regimen was not superior to individual regimens in preventing CIN in patients with baseline renal impairment. There was a trend suggesting that the 12-hour sustained sodium chloride pre-hydration regimen was more protective than the 1-hour abbreviated SOB regimen.