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CRS Clinical Trial
Summary: The primary efficacy objective is to assess the effect of RenalPro Therapy in reducing the rates of AKI after cardiac surgery in patients at risk of developing CSA-AKI.
Study Design: This is a multicenter, randomized, controlled, parallel-arm, open-label adaptive design study performed to evaluate the safety and the efficacy of RenalPro Therapy in reducing the rate of AKI in patients undergoing cardiac surgery, compared to the standard of care. The trial will consist of 4 phases: screening and baseline, treatment phase, post-op follow-up and long-term follow-up.
Proposed Indication for Use: The RenalPro Therapy is designed to maintain an increased urine flow rate with matched replacement of IV infusion. This maintains the patient’s intravascular fluid volume, which is intended to assist in reducing the rate of AKI in patients at risk for CSA-AKI. For patients undergoing cardiac surgery, the device is initiated at the start of anesthesia, runs through the duration of surgery, and continues for six hours post-admission to the intensive care unit.
Study Design: This is a multicenter, randomized, controlled, parallel-arm, open-label adaptive design study performed to evaluate the safety and the efficacy of RenalPro Therapy in reducing the rate of AKI in patients undergoing cardiac surgery, compared to the standard of care. The trial will consist of 4 phases: screening and baseline, treatment phase, post-op follow-up and long-term follow-up.
Proposed Indication for Use: The RenalPro Therapy is designed to maintain an increased urine flow rate with matched replacement of IV infusion. This maintains the patient’s intravascular fluid volume, which is intended to assist in reducing the rate of AKI in patients at risk for CSA-AKI. For patients undergoing cardiac surgery, the device is initiated at the start of anesthesia, runs through the duration of surgery, and continues for six hours post-admission to the intensive care unit.