NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial
Kaiser Permanente
Summary
A Randomized, Double-blind, placebo-controlled Trial to Evaluate the Efficacy of Oral Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery
Description
This trial is a single-center, randomized, double-blind placebo-controlled Trial of Nam versus placebo in patients undergoing on-pump cardiac surgery. After screening and enrollment, patients will be stratified according to CKD status (eGFR\<45 ml/min/m2) and surgical site and randomized in a 1:1 manner to receive either Nam 3 grams or placebo on the day of surgery and post-surgical days one and two. The overall trial duration is planned for 42 months, consisting of 39 months of active recruitment and treatment period and three months of follow-up from the last patient enrolled.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Informed consent before any study-related activities. * Men or women \>18 years of age who are scheduled for non-emergent cardiac surgery procedures requiring CPB and are at increased risk for surgery-related adverse cardiovascular outcomes. Procedures include: * CABG * Aortic, mitral, tricuspid, or pulmonic valve replacement or repair * CABG with aortic, mitral, tricuspid, and/or pulmonic valve replacement Risk factors for surgery related to adverse cardiovascular outcomes include one or more of the following: * Valve surgery * eGFR \< 45 ml/min/1.73m2 * Documented L…
Interventions
- DrugNiacinamide
Niacinamide 3 grams on the day of surgery and post-surgical days one and two
- DrugPlacebo
Matched placebo on the day of surgery and post-surgical days one and two
Location
- Kaiser Permanente San Francisco Medical CenterSan Francisco, California