Phase
Condition
Organ Transplant
Myocardial Ischemia
Kidney Disease
Treatment
Placebo
Niacinamide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Study Description
Connect with a study center
Kaiser Permanente San Francisco Medical Center
San Francisco, California 94115
United StatesActive - Recruiting
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