Assessing RenalGuard Therapy for preventing kidney injury after heart surgery

Post-Marketing Clinical Follow Up Study to Further Assess the Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI)

This study tests if RenalGuard Therapy can help prevent kidney injury in patients at risk after heart surgery compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CardioRenal Systems, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 8 sites (Hasselt and 7 other locations)
• Trial ID: NCT06811805 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of RenalGuard Therapy in reducing the incidence of Acute Kidney Injury (AKI) within 72 hours following cardiac surgery in patients at risk for Cardiac Surgery Associated AKI (CSA-AKI). Participants will be randomly assigned to receive either RenalGuard treatment or standard care during and after their surgery. The RenalGuard treatment aims to maintain a specific urine output threshold to protect kidney function. The study will compare outcomes between the two groups to determine the therapy's safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 scheduled for non-emergent cardiac surgeries with specific risk factors for CSA-AKI.

Not a fit: Patients not undergoing cardiac surgery or those without risk factors for CSA-AKI may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly reduce the occurrence of kidney injury in patients undergoing cardiac surgery.

How similar studies have performed: Previous studies have shown promising results with similar interventions aimed at preventing AKI in surgical settings.

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.

Where this trial is running

Hasselt and 7 other locations

• Jessa Medica Center — Hasselt, Belgium (Recruiting)
• TUM Klinikum Deutsches Herzzentrum — Munich, Germany (Recruiting)
• Uniklinikum Munster — Munster, Germany (Recruiting)
• Rambam Medical Center — Haifa, Israel (Recruiting)
• Rabin Medical Center - Belinson Campus — Petah Tikva, Israel (Recruiting)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
• Hospital Universitario Ramón y Cajal — Madrid, Spain (Recruiting)
• Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)

Study contacts

• Principal investigator: Alex Zarbock, MD — Uniklinikum Munster
• Study coordinator: Shmulik Adler SVP Regulatory and Clinical Affairs

Conditions AKI - Acute Kidney Injury; Cardiac Surgery Associated - Acute Kidney Injury; RenalGuard; AKI; Acute Kidney Injury; Cardiac Surgery Associated AKI; CSA-AKI; AKI Prevention