Using Niacinamide to Prevent Kidney Injury in Heart Surgery Patients
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial
This study is testing if taking Niacinamide can help prevent kidney injury in patients having heart surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kaiser Permanente Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04750616 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of oral Niacinamide (Nam) in preventing acute kidney injury in patients undergoing on-pump cardiac surgery. It is a randomized, double-blind, placebo-controlled study where participants will receive either Nam or a placebo on the day of surgery and for two days post-surgery. Patients will be stratified based on their chronic kidney disease status and surgical site to ensure appropriate matching. The trial will last for 42 months, including 39 months of recruitment and treatment followed by a three-month follow-up period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for non-emergent cardiac surgeries with increased risk for adverse cardiovascular outcomes.
Not a fit: Patients not undergoing on-pump cardiac surgery or those without risk factors for surgery-related complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of acute kidney injury in patients undergoing cardiac surgery.
How similar studies have performed: Other studies have shown promise in using similar approaches to mitigate kidney injury during cardiac procedures, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 LVEF ≤ 35% within six months before surgery * Documented history of heart failure * Insulin-requiring diabetes * Non-insulin-requiring diabetes and the presence of ≥+2 proteinuria on urinalysis (or equivalent on urine protein-to-creatinine ratio or urine albumin-to-creatinine ratio) * Preoperative anemia (hemoglobin \<11g/dl for men and women) * History of prior CABG * Age ≥65 Exclusion Criteria * Preexisting AKI within seven days before surgery as defined by KDIGO stage ≥1 (serum creatinine-based) * Kidney transplant status * Off-pump cardiac surgery * ESRD * Emergent cardiac surgery * Pregnancy * Patient enrolled in competing research studies that may affect outcomes * Patients held in an institution by legal or official order
Where this trial is running
San Francisco, California
- Kaiser Permanente San Francisco Medical Center — San Francisco, California, United States (Recruiting)
Study contacts
- Study coordinator: Ali Poyan Mehr, MD
- Email: ali.x.poyanmehr@kp.org
- Phone: 4152644750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.