NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

Launched by KAISER PERMANENTE · Feb 10, 2021

Keywords

ClinConnect Summary

The NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial is a research study looking at whether a supplement called Nam can help prevent kidney problems in patients who are having heart surgery that requires a heart-lung machine. This surgery can sometimes lead to complications such as heart and kidney injuries, especially in patients who are at higher risk. The study is currently recruiting participants who are 18 years or older and scheduled for certain types of planned heart surgeries, such as valve replacements or coronary artery bypass grafting (CABG). To qualify, patients should have specific health issues that increase their risk during surgery, like advanced age, diabetes, or heart failure.

If you decide to participate in this trial, you will be randomly assigned to receive either the Nam supplement or a placebo (a pill that has no active ingredients) without knowing which one you got. This helps researchers determine if Nam is effective. Throughout the study, you will be monitored closely for any kidney problems or other complications after your surgery. It's important to note that certain conditions, such as recent kidney injury or emergency surgeries, would make you ineligible for this trial. Your involvement could help advance our understanding of protecting kidney health during heart surgeries.

Gender

ALL

Eligibility 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