Protection From Acute Kidney Injury (AKI) With Basisâ„¢ Treatment (NCT04342975) | Clinical Trial Compass
CompletedPhase 2
Protection From Acute Kidney Injury (AKI) With Basisâ„¢ Treatment
United States54 participantsStarted 2020-12-01
Plain-language summary
This study is a single-center, prospective, randomized, double-blinded, placebo-controlled phase II clinical trial to evaluate the efficacy of "NAD+ supplementation" with Basisâ„¢ (Nicotinamide Riboside and Pterostilbene) in preventing acute kidney injury (AKI) in patients undergoing complex aortic aneurysm repair and open aortic arch reconstruction.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female;
✓. Age \> 18 years old;
✓. Patients who match the criteria for indication of elective open aortic arch replacement or repair:
✓. Total arch;
✓. Non-total arch;
✓. Patients who match the criteria for indication of elective complex aortic aneurysm repair has to respect the following conditions:
✓. Patients will be allowed to participate in concomitant endovascular aortic stent-graft trials and prospective cohort studies as long as these do not involve another investigational study drug.
Exclusion criteria
✕.2.1 General Exclusion Criteria
✕. Unwilling to comply with the follow-up schedule;
✕. Inability or refusal to give informed consent by the patient or a legally authorized representative;
✕. Pregnant or breastfeeding;
✕. Subject who takes multivitamins containing vitamin B3 derivatives in a dose \> 200 mg/day; 5.2.2 Clinical / Laboratory Exclusion Criteria
✕. Renal failure defined as eGFR\< 15 mL/min/1.73m2