Post-Marketing Study to Assess the Safety & Efficacy of RenalGuard® Therapy for Prevention CSA-AKI

Launched by CARDIORENAL SYSTEMS, INC. · Feb 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called RenalGuard Therapy to see if it can help prevent Acute Kidney Injury (AKI) in patients at risk who are undergoing cardiac surgery. AKI can happen after surgery, especially in certain patients, and this trial aims to find out if using the RenalGuard system can lower the chances of developing this condition compared to standard care practices. Participants will be randomly assigned to either receive RenalGuard Therapy during and after their surgery or to follow the usual care guidelines.

To be eligible for this trial, patients must be over 18 years old, able to give consent, and scheduled for specific cardiac surgeries that require a heart-lung machine. They also need to have at least one risk factor for developing AKI, like being older than 75 or having certain heart or kidney conditions. During the trial, participants will be monitored for up to a week after surgery, with a follow-up check at 90 days post-surgery. It’s important to know that this study is currently recruiting participants, and those interested should discuss with their doctor to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female and \>18 years of age
• • 2. Patient able to give written consent
• 3. Scheduled for the following non-emergent cardiac surgery procedure requiring CPB, isolated or in combination:
• • coronary artery bypass graft (CABG)
• • aortic valve replacement or repair alone, with or without aortic root repair
• • mitral, tricuspid, or pulmonic valve replacement or repair
• • simultaneous replacement of several cardiac valves
• • CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
• • Surgery on the aorta: aortic root and/ or ascending aorta
• • Atrial fibrillation (AF) ablation surgery if combined with other cardiac procedures.
• • Atrial septal defect (ASD) closure if combined with other cardiac procedures.
• • Excision of myxoma if combined with other cardiac procedures
• 4. Have at least one of the following risk factors for CSA-AKI:
• • CKD-EPI eGFR 20-59 mL/min/1.73 m²
• • Age ≥ 75 years
• • Undergoing combined surgery (e.g. CABG + Valve)
• • Logistic EuroScore of ≥5 or, Euroscore II of ≥4 or Society of Thoracic Surgeons (STS) Score ≥4
• • Left ventricular ejection fraction (LVEF) ≤ 35% by invasive or noninvasive diagnostic cardiac imaging performed within 90 days prior to surgery.
• • Insulin-requiring diabetes
• • Non-insulin-requiring diabetes with HbA1C ≥ 6.1% in the last 6 months
• • Preoperative anemia within 4 weeks of surgery
• 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. Patients participating in another interventional drug or device study or have received an investigational drug or device treatment within the last 30 days
• • 9. Pregnant patient, self-reported
• • 10. Patients whose planned surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature \< 28°Celsius (82.4° Fahrenheit)
• • 11. Patient with suspected or confirmed bacteraemia, endocarditis, or pyelonephritis at hospital admission
• • 12. 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
• • 13. Patients in cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices (Impella Heart Pump, IABP) within 24 hours prior to surgery
• • 14. 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
• • 15. Patients currently treated with chemotherapy or radiation therapy that may have an impact on kidney function.
• • 16. Patient underwent prior solid organ transplantation
• • 17. Patients underwent major surgery within the last 3 months
• • 18. Any condition which, in the judgement of the investigator, might increase the risk to the patient.