Efficacy of nicorandil treatment for prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization: A prospective randomized controlled trial.

BACKGROUND: Contrast-induced nephropathy (CIN) remains to be a potentially serious complication of radiographic procedures and is the third leading cause of the acute kidney injury (AKI) among hospitalized patients. This clinical trial was performed to assess the preventive effect of oral nicorandil on CIN in high-risk patients undergoing cardiac catheterization. METHODS: In this prospective, randomized, controlled trial, 128 patients with at least two risk factors for CIN undergoing elective percutaneous coronary intervention (PCI) were randomly assigned to either the nicorandil group or the control group. Patients in the nicorandil group (n = 64) received 10 mg nicorandil, daily from 30 min before and up to 3 days after procedure and intravenous hydration for 2 h before and 6 h after the procedure, whereas patients in the control group (n = 64) just received intravenous hydration. Serum creatinine (SCr) was measured before contrast exposure and at 72 h. CIN was defined as an increase of 25% in SCr or > 0.5 mg/dL 72 h after contrast administration. RESULTS: Contrast-induced nephropathy occurred in 14 out of 64 (21.9%) patients in the control group and in 3 out of 64 (4.7%) patients in the nicorandil group. There was a significant difference in the incidence of CIN between the two groups at 72 h after administering the radiocontrast agent (p = 0.008). Moreover, there were significant differences between the two groups in SCr and estimated glomerular filtration rate 72 h after radiocontrast administration (p < 0.05). CONCLUSIONS: The findings revealed that oral nicorandil had substantial efficacy over hydration protocol for the development of CIN in high-risk patients undergoing cardiac catheterization.