A Clinical Trial of Comparison between Sodium Bicarbonate and Sodium Chloride Effects for Prevention of Contrast-Induced Acute Kidney Injury Following Diagnostic Coronary Angiography

Objectives: The purpose of this study is to compare the incidence of contrast-induced acute kidney injury (CI-AKI) following coronary angiography after administration of sodium bicarbonate and sodium chloride. Design: This investigation is randomized and single-blinded. Setting and conduct: All patients undergoing coronary angiography are assessed and those who fulfill inclusion criteria are enrolled. One-hundred fifty eight patients are entered into two groups including seventy nine patients. A written informed consent is obtained from all of the patients. And then, all of them will be followed concerning incidence of CI-AKI at 48 hours after coronary angiography. Participants including major eligibility criteria: The major inclusion criteria include creatinin level greater than 1.5 mg/dl in men and greater than 1.4 mg/dl in women; creatinin clearance less than 60 ml/min/1.73 m2; older than 18 years; and history of diabetes mellitus for more than one year. The exclusion criteria include cardiogenic shock; heart failure; acute coronary syndrome recently undergone angiography or angioplasty; recent dialysis; single kidney; and any infusion of contrast media such as radiologic interventions. Intervention: Group 1 receives sodium chloride 0.9% as 1 mg/kg/h through 12 hours before and after coronary angiography. Group 2 undergoes infusion of sodium bicarbonate (154 mEq in serum DW5%) as 3 mg/kg/h during 1 hour prior to coronary angiography and as 1 mg/kg/h during 6 hours after coronary angiography. Main outcome measures: The patients with rising in their creatinin level either up to 0.5 mg/dl or 25% more than basic amount are considered as CI-AKI

No 1, Vice chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah, Iran.