The purpose of this single-center, randomized, double-blinded placebo-controlled pilot trial is to demonstrate feasibility and help design a larger trial to assess the effectiveness of nicotinamide (NAM) supplementation in reducing risk of post-operative AKI in patients undergoing cardiac surgery.
Age ≥18 years
Undergoing coronary artery bypass graft (CABG) and/or valve surgery with cardiopulmonary bypass (CPB) at BIDMC. Includes combination surgeries that involve CABG and/or valve plus other procedures (e.g., Maze procedure, aortic aneurysm repair).
AKI risk score ≥6 at the time of screening
Increase in serum creatinine ≥0.3 mg/dl in 48h
Increase in serum creatinine ≥50% in 7d (if no value available in last 7d, use most recent value in last 3 months)
Urine output ≤0.5 ml/kg/h x 6 consecutive hours (only assessed in patients with hourly monitoring via Foley catheter)
Receipt of renal replacement therapy (RRT) within 7d
Parallel
Nicotinamide (NAM)
Dietary supplementA one time 3000 mg nicotinamide dose administered orally on the morning of cardiac surgery
Placebo control
Dietary supplementA visually identically placebo
Post Operative day 1 urinary KIM-1
Measurement of urinary KIM-1 pre-bypass and on post-operative day 1 compared via t-test.
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This trial is not recruiting at the moment. You can still explore other options:
