Evaluation of Sodium Bicarbonate to Reduce Contrast-Induced Nephropathy (CIN) in Subjects with Advanced Chronic Kidney Disease (CKD) who are Undergoing Angiography [BOSS TRIAL]
ID Number 10-0956Principal Investigator(s)
Michael C. Kim
Department(s) or Division(s)
The purpose of this study is to evaluate two different solutions to see which works better in preventing kidney disease (nephropathy) and kidney failure that occurs in some patients after completing the contrast procedure. In this study, the participant will be given either the saline solution or the investigational sodium bicarbonate solution before, during, and after the contrast procedure at hospital. Sodium bicarbonate solution has not been approved for this use by the U.S. Food and Drug Administration (FDA). The number of participants expected in this study is 536 subjects in 4-20 centers in the United States. The total enrollment number at Mount Sinai Medical Center will be 10 subjects. Participation in this study is expected to last 6 months. The telephone follow-ups and blood test will be at 180-day and 190-day.
Recruiting Patients: Yes