About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nicotinamide (NAM)
- Placebo control