Status:
RECRUITING
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Beth Israel Deaconess Medical Center
Conditions:
Ischemia Reperfusion Injury
Myocardial Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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
Exclusion
Key Trial Info
Start Date :
September 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT04750616
Start Date
September 13 2021
End Date
June 30 2025
Last Update
March 12 2025
Active Locations (1)
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1
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States, 94115