The goal of this clinical trial is to assess the effect of RenalGuard Therapy in reducing the rates of Acute Kidney Injury (AKI) within 72 hours after cardiac surgery in patients at risk of developing Cardiac Surgery Associated AKI (CSA-AKI) compared to standard-of-care (SoC).
Participants will be randomized (1:1) to one of the two study groups. The Treatment study group will be managed with the RenalGuard System. The RenalGuard treatment will start after induction of anesthesiology and will run during surgery and for 6-7 hours in the Intensive Care Unit (ICU). The treatment will aim to achieve a urine rate above a predefined urine rate threshold. Patients in the control group will be managed based on the usual clinical practice in cardiac surgery centres as detailed in the recommendations for CSA-AKI prevention by accepted clinical guidelines.
For both study groups general anaesthesia, cardiopulmonary bypass (CPB) run and overall patient care will be based on SoC for cardiac surgery.
Patients will be followed up for up to 7 days post surgery or until discharge, which ever comes first.
Long-term follow up will be performed at 90 days post surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Male or female and \>18 years of age
âś“. Patient able to give written consent
âś“. Scheduled for the following non-emergent cardiac surgery procedure requiring CPB, isolated or in combination:
âś“. Have at least one of the following risk factors for CSA-AKI:
Exclusion criteria
âś•. Patient requiring emergency surgery
âś•. Surgery to be performed without CPB
âś•. Patient receiving furosemide at a dose\>100 mg/day orally (or the equivalent dose of an alternative loop diuretic) in the last week
âś•. Patient who cannot be urethrally catheterize for any reason
âś•. Patients already dialysis dependent
✕. Patients with CKD-EPI eGFR \<20 mL/min/1.73 m²
. Known or suspected AKI (KDIGO criteria) at the time of screening
âś•. Patients participating in another interventional drug or device study or have received an investigational drug or device treatment within the last 30 days