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NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
RECRUITINGPhase 2Sponsored by Kaiser Permanente
Actively Recruiting
PhasePhase 2
SponsorKaiser Permanente
Started2021-09-13
Est. completion2025-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT04750616
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions4
Acute Kidney InjuryHeart DiseaseIschemia-Reperfusion InjuryMyocardial Injury
Locations1 site
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94115
Ali Poyan Mehr, MD
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Actively Recruiting
PhasePhase 2
SponsorKaiser Permanente
Started2021-09-13
Est. completion2025-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT04750616