NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Collaborators: Beth Israel Deaconess Medical Center; Cedars-Sinai Medical Center; National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Niacin; Niacinamide; Nicotinic Acids

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