Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury

Exclusion Criteria

• •1. Patient requiring emergency surgery
• •2. Surgery to be performed without CPB
• •3. Patient receiving furosemide at a dose\>100 mg/day orally (or the equivalent dose of an alternative loop diuretic) in the last week
• •4. Patient who cannot be urethrally catheterize for any reason
• •5. Patients already dialysis dependent
• •6. Patients with CKD-EPI eGFR \<20 mL/min/1.73 m²
• •7. Known or suspected AKI (KDIGO criteria) at the time of screening
• •8. IV contrast within 48 hours of surgery
• •9. Patients participating in another interventional drug or device study or have received an investigational drug or device treatment within the last 30 days
• •10. Pregnant patient, self-reported
• •11. Patients whose planned surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature \< 28°Celsius (82.4° Fahrenheit)
• •12. Patient with suspected or confirmed bacteraemia, endocarditis, or pyelonephritis at hospital admission
• •13. Patients with pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious aetiology reported on chest x-ray or CT scan in the last 7 days
• •14. Patients in cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices (Impella, IABP) within 24 hours prior to surgery
• •15. Patients on extracorporeal membrane oxygenation (ECMO) or durable ventricular assist device (VAD) at the time of screening, or planned use within 24h prior to surgery
• •16. Patients currently treated with chemotherapy or radiation therapy that may have an impact on kidney function.
• •17. Patient underwent prior solid organ transplantation
• •18. Patients underwent major surgery within the last 3 months
• •19. Any condition which, in the judgement of the investigator, might increase the risk to the patient