RecruitingPhase 2NCT04750616
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial
Sponsor
Kaiser Permanente
Enrollment
304 participants
Start Date
Sep 13, 2021
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Min Age: 18 Years
Inclusion Criteria16
- 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 Criteria8
- 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
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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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04750616
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