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Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury
Sponsor: CardioRenal Systems, Inc.
Summary
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). The study is planned to be conducted in 2 clinical sites in the Malaysia - Universiti Malaya Medical Centre and Institut Jantung Negara, Kuala Lumpur, Malaysia. 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.
Official title: Assessing the Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) - SAFEGUARD Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-09-01
Completion Date
2027-06-30
Last Updated
2025-08-14
Healthy Volunteers
No
Interventions
RenalGuard® Therapy
RenalGuard Therapy®
Standard of Care (SOC)
Standard of care
Locations (2)
Institut Jantung Negara
Kuala Lumpur, Malaysia
Universiti Malaya Medical Centre
Kuala Lumpur, Malaysia