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)

Kaiser Permanente San Francisco Medical Center

San Francisco, California, United States

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NCT04750616


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