A Study to Evaluate the Effectiveness of Nicotinamide Riboside and Pterostilbene Treatment to Protect the Kidneys in Patients with Complex Aortic Aneurysm Repair and Aortic Arch Reconstruction

Overview

About this study

The purpose of this study is to determine the effectiveness of Basis™ (Nicotinamide Riboside and Pterostilbene) in preventing acute kidney injury (AKI) among patients undergoing complex aortic aneurysm repair and aortic arch reconstruction.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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 undergoing complex aortic aneurysm open reconstruction with a suprarenal clamp:
      • thoracoabdominal aortic aneurysms Crawford extent I to IV;
      • abdominal aortic aneurysms of juxtarenal, pararenal, or paravisceral type.
    • For endovascular approach:
      • patients with pararenal or thoracoabdominal aortic aneurysms Crawford extent I to IV and known stage III or IV CKD;
      • patients with pararenal or thoracoabdominal aortic aneurysms Crawford extent I to IV and solitary or single functioning kidney and known stage III or IV CKD.
  • 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.

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.

Clinical / Laboratory Exclusion Criteria:

  • Renal failure defined as eGFR< 15 mL/min/1.73m2.
  • Patients in permanent Renal Replacement Therapy.
  • Patients with chronic liver disease: Child-Pugh score class B and C.

Medication Exclusion Criteria:

  • Patients in chemotherapy scheme.
  • Patients taking any immunosuppressant, except for corticosteroids.
  • Patients taking any of these well-known P-glycoprotein substrates: digoxin, fexofenadine, indinavir, sirolimus.
    • For some types of P-glycoprotein substrates, subjects will be closely monitored.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Eduardo Chini, M.D., Ph.D.

Contact us for the latest status

Contact information:

Anesthesia Clinical Research Unit

(507) 422-0582

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20469594

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