Protection From Acute Kidney Injury (AKI) With Basis™ Treatment

Inclusion criteria

• A patient may be included in the study if the following conditions are present:

• 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:

a. Patients undergoing complex aortic aneurysm open reconstruction with a suprarenal clamp; i. thoracoabdominal aortic aneurysms Crawford extent I to IV ; ii. abdominal aortic aneurysms of juxtarenal, pararenal, or paravisceral type; b. For endovascular approach: i. patients with pararenal or thoracoabdominal aortic aneurysms Crawford extent I to IV and known stage III or IV of chronic kidney disease (CKD); ii. 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.

Exclusion criteria

• Patients must be excluded from the study if any of the following conditions are true:

5.2.1 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
• Patients in permanent Renal Replacement Therapy;
• Patients with chronic liver disease: Child-Pugh score class B and C; 5.2.3 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.