NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Ischemia Reperfusion Injury, Myocardial Injury, Acute Kidney Injury
In brief
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
Key facts
- Study ID
- NCT04750616
- Run by
- Kaiser Permanente
- People needed
- 304
- Starts
- 2021-09-13
- Expected to finish
- 2025-06-30
- Last updated by the study team
- 2025-03-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Kaiser Permanente San Francisco Medical Center — San Francisco, California, United States (enrolling)
Full record on ClinicalTrials.gov
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