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NCT04750616PHASE2Recruiting

NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

Kaiser Permanente

Start Date

9/13/2021

Completion Date

6/30/2025

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

Detailed Description

This trial is a single-center, randomized, double-blind placebo-controlled Trial of Nam versus placebo in patients undergoing on-pump cardiac surgery. After screening and enrollment, patients will be stratified according to CKD status (eGFR\<45 ml/min/m2) and surgical site and randomized in a 1:1 manner to receive either Nam 3 grams or placebo on the day of surgery and post-surgical days one and two. The overall trial duration is planned for 42 months, consisting of 39 months of active recruitment and treatment period and three months of follow-up from the last patient enrolled.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Niacinamide

DRUG

Placebo

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Conditions

Ischemia Reperfusion InjuryMyocardial InjuryAcute Kidney Injury

Locations

Kaiser Permanente San Francisco Medical Center

San Francisco, California 94115

United States