This study is a single-center, prospective, randomized, double-blinded, placebo-controlled phase II clinical trial to evaluate the efficacy of "NAD+ supplementation" with Basis™ (Nicotinamide Riboside and Pterostilbene) in preventing acute kidney injury (AKI) in patients undergoing complex aortic aneurysm repair and open aortic arch reconstruction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
54
It will be administered a total of 1000 mg/day of NR and 200 mg/day of Ptero in a regimen of 2 capsules of Basis™ (each capsule 250 mg of NR and 50 mg of Ptero) 2 times a day by mouth for 2 weeks before surgery and 6 weeks after surgery. Each intake has to be apart from each other by, at least, 6 hours of interval.
The correspondent placebo will be administered in a regimen of 2 capsules 2 times a day by mouth for 2 weeks before surgery and 6 weeks after surgery. Each intake has to be apart from each other by, at least, 6 hours of interval.
Mayo Clinic
Rochester, Minnesota, United States
AKI
The primary endpoint will be change in incidence of AKI measured by estimated glomerular filtration rate (eGFR) using the RIFLE criteria.
Time frame: 6 months
Myocardial infarction
The secondary endpoint will be change in the incidence of myocardial infarction
Time frame: 6 months
Bowel ischemia
The secondary endpoint will be change in the incidence of bowel ischemia
Time frame: 6 months
Spinal cord injury
The secondary endpoint will be change in the incidence of spinal cord injury
Time frame: 6 months
Nicotinamide Adenine Dinucleotide (NAD), Nicotinamide Mononucleotide (NMN), and Nicotinamide Riboside (NR)
NAD, NMN, NR levels in peripheral blood mononuclear cells (PBMCs)
Time frame: 6 months
Tissue Inhibitor of Metalloproteinases 2 (TIMP2), Kidney Injury Molecule 1 (KIM-1), Insulin-like Growth Factor-binding Protein 7 (IGFBP7)
TIMP2, KIM-1, IGFBP7 levels in urine
Time frame: 6 months
Quinolinate and Tryptophan
Quinolinate and Tryptophan levels in urine
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.